Created at Source Raw Value Validated value
June 25, 2024, noon usa

inclusion criteria: * signed informed consent. * documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry. laboratory-confirmed sars-cov-2 infection outside the us must be conducted at a daids-approved laboratory. * able to begin study treatment no later than 7 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: * subjective fever or feeling feverish * cough * shortness of breath or difficulty breathing at rest or with activity * sore throat * body pain or muscle pain/aches * fatigue * headache * chills * nasal obstruction or congestion * nasal discharge * loss of taste or smell * nausea or vomiting * diarrhea * temperature \> 38°c (100.4°f) * one or more of the following signs/symptoms within 24 hours of participating in the study: * subjective fever or feeling feverish * cough * shortness of breath or difficulty breathing at rest or with activity * sore throat * body pain or muscle pain/aches * fatigue * headache * chills * nasal obstruction or congestion * nasal discharge * loss of taste or smell * nausea or vomiting * diarrhea * temperature \> 38°c (100.4°f) * oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study staff within 24 hours of study entry. for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. * participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. * meet the protocol definition of being at "higher" risk of progression to hospitalization or death (brii-196/brii-198). * in phase iii, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (sng001, sab-185, bms 986414+bms 986413) * for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 \[iv\], azd7442 \[im\], sng001, camostat, sab-185, bms 986414+bms 986413). * participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 \[iv\], azd7442 \[im\], sab-185). * participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). * participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). * if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 24 weeks after investigational agent is administered. this would include oral contraceptives, implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier methods. * if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 \[iv\], azd7442 \[im\], sab-185). * if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). * if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat). * if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (bms 986414+bms 986413).

inclusion criteria: * signed informed consent. * documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry. laboratory-confirmed sars-cov-2 infection outside the us must be conducted at a daids-approved laboratory. * able to begin study treatment no later than 7 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: * subjective fever or feeling feverish * cough * shortness of breath or difficulty breathing at rest or with activity * sore throat * body pain or muscle pain/aches * fatigue * headache * chills * nasal obstruction or congestion * nasal discharge * loss of taste or smell * nausea or vomiting * diarrhea * temperature \> 38°c (100.4°f) * one or more of the following signs/symptoms within 24 hours of participating in the study: * subjective fever or feeling feverish * cough * shortness of breath or difficulty breathing at rest or with activity * sore throat * body pain or muscle pain/aches * fatigue * headache * chills * nasal obstruction or congestion * nasal discharge * loss of taste or smell * nausea or vomiting * diarrhea * temperature \> 38°c (100.4°f) * oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study staff within 24 hours of study entry. for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. * participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. * meet the protocol definition of being at "higher" risk of progression to hospitalization or death (brii-196/brii-198). * in phase iii, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (sng001, sab-185, bms 986414+bms 986413) * for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 \[iv\], azd7442 \[im\], sng001, camostat, sab-185, bms 986414+bms 986413). * participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 \[iv\], azd7442 \[im\], sab-185). * participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). * participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). * if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 24 weeks after investigational agent is administered. this would include oral contraceptives, implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier methods. * if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 \[iv\], azd7442 \[im\], sab-185). * if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). * if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat). * if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (bms 986414+bms 986413).

Sept. 18, 2021, 5 a.m. usa

inclusion criteria: - signed informed consent. - documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry. laboratory-confirmed sars-cov-2 infection outside the us must be conducted at a daids-approved laboratory. - able to begin study treatment no later than 7 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: - subjective fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or with activity - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - nasal obstruction or congestion - nasal discharge - loss of taste or smell - nausea or vomiting - diarrhea - temperature > 38°c (100.4°f) - one or more of the following signs/symptoms within 24 hours of participating in the study: - subjective fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or with activity - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - nasal obstruction or congestion - nasal discharge - loss of taste or smell - nausea or vomiting - diarrhea - temperature > 38°c (100.4°f) - oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study staff within 24 hours of study entry. for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. - meet the protocol definition of being at "higher" risk of progression to hospitalization or death (brii-196/brii-198). - in phase iii, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (sng001, sab-185, bms 986414+bms 986413) - for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 [iv], azd7442 [im], sng001, camostat, sab-185, bms 986414+bms 986413). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 [iv], azd7442 [im], sab-185). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 24 weeks after investigational agent is administered. this would include oral contraceptives, implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier methods. - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 [iv], azd7442 [im], sab-185). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (bms 986414+bms 986413).

inclusion criteria: - signed informed consent. - documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry. laboratory-confirmed sars-cov-2 infection outside the us must be conducted at a daids-approved laboratory. - able to begin study treatment no later than 7 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: - subjective fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or with activity - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - nasal obstruction or congestion - nasal discharge - loss of taste or smell - nausea or vomiting - diarrhea - temperature > 38°c (100.4°f) - one or more of the following signs/symptoms within 24 hours of participating in the study: - subjective fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or with activity - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - nasal obstruction or congestion - nasal discharge - loss of taste or smell - nausea or vomiting - diarrhea - temperature > 38°c (100.4°f) - oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study staff within 24 hours of study entry. for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. - meet the protocol definition of being at "higher" risk of progression to hospitalization or death (brii-196/brii-198). - in phase iii, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (sng001, sab-185, bms 986414+bms 986413) - for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 [iv], azd7442 [im], sng001, camostat, sab-185, bms 986414+bms 986413). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 [iv], azd7442 [im], sab-185). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 24 weeks after investigational agent is administered. this would include oral contraceptives, implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier methods. - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 [iv], azd7442 [im], sab-185). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (bms 986414+bms 986413).

Aug. 25, 2021, 7:30 p.m. usa

inclusion criteria: - signed informed consent. - documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry and conducted an any us clinic or laboratory that has a clinical laboratory improvement amendments (clia) certification or its equivalent or any non-us daids-approved laboratory. - able to begin study treatment no later than 7 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: - subjective fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or with activity - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - nasal obstruction or congestion - nasal discharge - loss of taste or smell - nausea or vomiting - diarrhea - temperature > 38°c (100.4°f) - one or more of the following signs/symptoms within 24 hours of participating in the study: - subjective fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or with activity - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - nasal obstruction or congestion - nasal discharge - loss of taste or smell - nausea or vomiting - diarrhea - temperature > 38°c (100.4°f) - oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study staff within 24 hours of study entry. for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. - meet the protocol definition of being at "higher" risk of progression to hospitalization or death (brii-196/brii-198). - in phase iii, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (sng001, sab-185, bms 986414+bms 986413) - for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 [iv], azd7442 [im], sng001, camostat, sab-185, bms 986414+bms 986413). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 [iv], azd7442 [im], sab-185). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 24 weeks after investigational agent is administered. this would include oral contraceptives, implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier methods. - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 [iv], azd7442 [im], sab-185). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (bms 986414+bms 986413).

inclusion criteria: - signed informed consent. - documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry and conducted an any us clinic or laboratory that has a clinical laboratory improvement amendments (clia) certification or its equivalent or any non-us daids-approved laboratory. - able to begin study treatment no later than 7 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: - subjective fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or with activity - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - nasal obstruction or congestion - nasal discharge - loss of taste or smell - nausea or vomiting - diarrhea - temperature > 38°c (100.4°f) - one or more of the following signs/symptoms within 24 hours of participating in the study: - subjective fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or with activity - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - nasal obstruction or congestion - nasal discharge - loss of taste or smell - nausea or vomiting - diarrhea - temperature > 38°c (100.4°f) - oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study staff within 24 hours of study entry. for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. - meet the protocol definition of being at "higher" risk of progression to hospitalization or death (brii-196/brii-198). - in phase iii, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (sng001, sab-185, bms 986414+bms 986413) - for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 [iv], azd7442 [im], sng001, camostat, sab-185, bms 986414+bms 986413). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 [iv], azd7442 [im], sab-185). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 24 weeks after investigational agent is administered. this would include oral contraceptives, implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier methods. - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 [iv], azd7442 [im], sab-185). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (bms 986414+bms 986413).

May 21, 2021, 12:31 a.m. usa

inclusion criteria: - signed informed consent. - documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry and conducted an any us clinic or laboratory that has a clinical laboratory improvement amendments (clia) certification or its equivalent or any non-us daids-approved laboratory. - able to begin study treatment no later than 8 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - one or more of the following signs/symptoms within 24 hours of participating in the study: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - oxygen levels of ≥92% when resting (measured by study staff within 24 hours of participating in the study). for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. - meet the protocol definition of being at "higher" risk of progression to severe covid-19 (brii-196/brii-198). - for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 [iv], azd7442 [im], sng001, camostat, sab-185, cl135-ls+c144-ls). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 [iv], azd7442 [im], sab-185). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 [iv], azd7442 [im], sab-185). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (c135-ls+c144-ls).

inclusion criteria: - signed informed consent. - documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry and conducted an any us clinic or laboratory that has a clinical laboratory improvement amendments (clia) certification or its equivalent or any non-us daids-approved laboratory. - able to begin study treatment no later than 8 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - one or more of the following signs/symptoms within 24 hours of participating in the study: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - oxygen levels of ≥92% when resting (measured by study staff within 24 hours of participating in the study). for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. - meet the protocol definition of being at "higher" risk of progression to severe covid-19 (brii-196/brii-198). - for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 [iv], azd7442 [im], sng001, camostat, sab-185, cl135-ls+c144-ls). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 [iv], azd7442 [im], sab-185). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 [iv], azd7442 [im], sab-185). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (c135-ls+c144-ls).

April 25, 2021, 12:31 a.m. usa

inclusion criteria: - signed informed consent. - documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry and conducted an any us clinic or laboratory that has a clinical laboratory improvement amendments (clia) certification or its equivalent or any non-us daids-approved laboratory. - able to begin study treatment no later than 8 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - one or more of the following signs/symptoms within 24 hours of participating in the study: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - oxygen levels of ≥92% when resting (measured by study staff within 24 hours of participating in the study). for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. - meet the protocol definition of being at "higher" risk of progression to severe covid-19 (brii-196/brii-198, azd7442 [iv]). - for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 [iv], azd7442 [im], sng001, camostat, sab-185, cl135-ls+c144-ls). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 [iv], azd7442 [im], sab-185). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 [iv], azd7442 [im], sab-185). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (c135-ls+c144-ls).

inclusion criteria: - signed informed consent. - documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry and conducted an any us clinic or laboratory that has a clinical laboratory improvement amendments (clia) certification or its equivalent or any non-us daids-approved laboratory. - able to begin study treatment no later than 8 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - one or more of the following signs/symptoms within 24 hours of participating in the study: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - oxygen levels of ≥92% when resting (measured by study staff within 24 hours of participating in the study). for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. - meet the protocol definition of being at "higher" risk of progression to severe covid-19 (brii-196/brii-198, azd7442 [iv]). - for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 [iv], azd7442 [im], sng001, camostat, sab-185, cl135-ls+c144-ls). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 [iv], azd7442 [im], sab-185). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 [iv], azd7442 [im], sab-185). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (c135-ls+c144-ls).

April 11, 2021, 12:31 a.m. usa

inclusion criteria: - signed informed consent. - documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry and conducted an any us clinic or laboratory that has a clinical laboratory improvement amendments (clia) certification or its equivalent or any non-us daids-approved laboratory. - able to begin study treatment no later than 8 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - one or more of the following signs/symptoms within 24 hours of participating in the study: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - oxygen levels of ≥92% when resting (measured by study staff within 24 hours of participating in the study). for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. - meet the protocol definition of being at "higher" risk of progression to severe covid-19 (brii-196/brii-198, azd7442 [iv]). - for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 [iv], azd7442 [im], sng001, camostat, cl135-ls+c144-ls). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 [iv], azd7442 [im]). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 [iv], azd7442 [im]). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (c135-ls+c144-ls).

inclusion criteria: - signed informed consent. - documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry and conducted an any us clinic or laboratory that has a clinical laboratory improvement amendments (clia) certification or its equivalent or any non-us daids-approved laboratory. - able to begin study treatment no later than 8 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - one or more of the following signs/symptoms within 24 hours of participating in the study: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - oxygen levels of ≥92% when resting (measured by study staff within 24 hours of participating in the study). for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. - meet the protocol definition of being at "higher" risk of progression to severe covid-19 (brii-196/brii-198, azd7442 [iv]). - for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 [iv], azd7442 [im], sng001, camostat, cl135-ls+c144-ls). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 [iv], azd7442 [im]). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 [iv], azd7442 [im]). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (c135-ls+c144-ls).

March 25, 2021, 12:31 a.m. usa

inclusion criteria: - signed informed consent. - documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry and conducted an any us clinic or laboratory that has a clinical laboratory improvement amendments (clia) certification or its equivalent or any non-us daids-approved laboratory. - able to begin study treatment no later than 8 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - one or more of the following signs/symptoms within 24 hours of participating in the study: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - oxygen levels of ≥92% when resting (measured by study staff within 24 hours of participating in the study). for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. - meet the protocol definition of being at "higher" risk of progression to severe covid-19 (brii-196/brii-198, azd7442 [iv]). - for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 [iv], azd7442 [im], sng001, camostat). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 [iv], azd7442 [im]). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 [iv], azd7442 [im]). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat).

inclusion criteria: - signed informed consent. - documentation of laboratory-confirmed sars-cov-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (np), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry and conducted an any us clinic or laboratory that has a clinical laboratory improvement amendments (clia) certification or its equivalent or any non-us daids-approved laboratory. - able to begin study treatment no later than 8 days from self-reported onset of covid-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - one or more of the following signs/symptoms within 24 hours of participating in the study: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - oxygen levels of ≥92% when resting (measured by study staff within 24 hours of participating in the study). for a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first. - meet the protocol definition of being at "higher" risk of progression to severe covid-19 (brii-196/brii-198, azd7442 [iv]). - for participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a clia certification or its equivalent, or by a point of care (poc)/clia-waived test. note: participants not of reproductive potential are eligible without requiring the use of a contraceptive method (brii-196/brii-198. azd7442 [iv], azd7442 [im], sng001, camostat). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. participants should refrain from sperm donation for 24 weeks after investigational agent administration (brii-196/brii-198, azd7442 [iv], azd7442 [im]). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. they are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. participants should refrain from sperm donation for 30 days after investigational agent administration (sng001). - participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. they are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (camostat). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (azd7442 [iv], azd7442 [im]). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (sng001). - if participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (camostat).

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria: - signed informed consent. - positive test for covid-19 up to 7 days before participation in study. - able to begin study treatment no later than 10 days from self-reported onset of covid-19 related symptom(s): - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - one or more of the following signs/symptoms within 48 hours of participating in the study: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - oxygen levels of ≥92% when resting (measured by study staff within 48 hours of participating in the study), unless participant is receiving long-term supplementary oxygen for an underlying lung condition. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first.

inclusion criteria: - signed informed consent. - positive test for covid-19 up to 7 days before participation in study. - able to begin study treatment no later than 10 days from self-reported onset of covid-19 related symptom(s): - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - one or more of the following signs/symptoms within 48 hours of participating in the study: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°c (100.4°f) - oxygen levels of ≥92% when resting (measured by study staff within 48 hours of participating in the study), unless participant is receiving long-term supplementary oxygen for an underlying lung condition. - participant must agree not to participate in another clinical trial for the treatment of covid-19 or sars-cov-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first.