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

inclusion criteria: inclusion criteria: 1. signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures. 2. men and women, ≥18 years of age at time of enrollment. 3. laboratory-confirmed diagnosis of sars-cov-2 infection as determined by pcr, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if rt-pcr test result not available only at the time of screening). 4. less than or equal to 9 days from covid-19 symptom onset to starting treatment. • symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other covid-19 symptoms as determined by the investigator. 5. hospitalized and i) requiring supplemental oxygen by face mask or nasal prongs, or ii) non-invasive ventilation or iii) high-flow oxygen (who category 4 or 5) 6. female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. male and female patients of reproductive potential must use a highly effective, protocol-specified method of contraception during the study and up to post 30 days after the last dose of study drug. for a list of protocol-specified contraceptive methods, and the definition of reproductive potential, refer to appendix 1.

inclusion criteria: inclusion criteria: 1. signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures. 2. men and women, ≥18 years of age at time of enrollment. 3. laboratory-confirmed diagnosis of sars-cov-2 infection as determined by pcr, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if rt-pcr test result not available only at the time of screening). 4. less than or equal to 9 days from covid-19 symptom onset to starting treatment. • symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other covid-19 symptoms as determined by the investigator. 5. hospitalized and i) requiring supplemental oxygen by face mask or nasal prongs, or ii) non-invasive ventilation or iii) high-flow oxygen (who category 4 or 5) 6. female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. male and female patients of reproductive potential must use a highly effective, protocol-specified method of contraception during the study and up to post 30 days after the last dose of study drug. for a list of protocol-specified contraceptive methods, and the definition of reproductive potential, refer to appendix 1.

June 4, 2022, 2 p.m. usa

inclusion criteria: inclusion criteria: signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures. men and women, ≥18 years of age at time of enrollment. laboratory-confirmed diagnosis of sars-cov-2 infection as determined by pcr, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if rt-pcr test result not available only at the time of screening). less than or equal to 9 days from covid-19 symptom onset to starting treatment. • symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other covid-19 symptoms as determined by the investigator. hospitalized and i) requiring supplemental oxygen by face mask or nasal prongs, or ii) non-invasive ventilation or iii) high-flow oxygen (who category 4 or 5) female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. male and female patients of reproductive potential must use a highly effective, protocol-specified method of contraception during the study and up to post 30 days after the last dose of study drug. for a list of protocol-specified contraceptive methods, and the definition of reproductive potential, refer to appendix 1.

inclusion criteria: inclusion criteria: signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures. men and women, ≥18 years of age at time of enrollment. laboratory-confirmed diagnosis of sars-cov-2 infection as determined by pcr, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if rt-pcr test result not available only at the time of screening). less than or equal to 9 days from covid-19 symptom onset to starting treatment. • symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other covid-19 symptoms as determined by the investigator. hospitalized and i) requiring supplemental oxygen by face mask or nasal prongs, or ii) non-invasive ventilation or iii) high-flow oxygen (who category 4 or 5) female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. male and female patients of reproductive potential must use a highly effective, protocol-specified method of contraception during the study and up to post 30 days after the last dose of study drug. for a list of protocol-specified contraceptive methods, and the definition of reproductive potential, refer to appendix 1.

Feb. 17, 2022, 5 p.m. usa

inclusion criteria: signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures. men and women, ≥18 years of age at time of enrollment. laboratory-confirmed diagnosis of sars-cov-2 infection as determined by pcr, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if rt-pcr test result not available only at the time of screening). less than or equal to 9 days from covid-19 symptom onset to starting treatment. • symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other covid-19 symptoms as determined by the investigator. hospitalized and i) requiring supplemental oxygen by face mask or nasal prongs, or ii) non-invasive ventilation or iii) high-flow oxygen (who category 4 or 5) female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. male and female patients of reproductive potential must use a highly effective, protocol-specified method of contraception during the study and up to post 30 days after the last dose of study drug. for a list of protocol-specified contraceptive methods, and the definition of reproductive potential, refer to appendix 1.

inclusion criteria: signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures. men and women, ≥18 years of age at time of enrollment. laboratory-confirmed diagnosis of sars-cov-2 infection as determined by pcr, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if rt-pcr test result not available only at the time of screening). less than or equal to 9 days from covid-19 symptom onset to starting treatment. • symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other covid-19 symptoms as determined by the investigator. hospitalized and i) requiring supplemental oxygen by face mask or nasal prongs, or ii) non-invasive ventilation or iii) high-flow oxygen (who category 4 or 5) female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. male and female patients of reproductive potential must use a highly effective, protocol-specified method of contraception during the study and up to post 30 days after the last dose of study drug. for a list of protocol-specified contraceptive methods, and the definition of reproductive potential, refer to appendix 1.

Dec. 18, 2020, 12:31 a.m. usa

inclusion criteria: - signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures. - men and women, ≥18 years of age at time of enrollment. - laboratory-confirmed diagnosis of sars-cov-2 infection as determined by pcr, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if rt-pcr test result not available at the time of screening). - less than or equal to 12 days from covid-19 symptom onset to starting treatment. - symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other covid-19 symptoms as determined by the investigator. - hospitalized for no more than 4 days duration, and: - requiring supplemental oxygen by mask or tongs, or ii) non-invasive ventilation or iii) high-flow oxygen (who category 4 or 5) - female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. male patients must agree to use appropriate contraceptive methods to prevent pregnancy with their partner(s), during the study and up to post 30 days after the last dose of study drug. female patients must be: - unable to have children (e.g., post-menopausal*, bilateral tubal ligation, hysterectomy, bilateral oophorectomy) or where the partner is sterile (e.g., vasectomy) or - willing to remain abstinent (not engage in sexual intercourse for the duration of the screening period and throughout the study, and for 30 days after the last dose) or - willing to use two effective barrier methods of birth control (partner using condom and female using iud, hormonal or nonhormonal contraceptive, diaphragm plus spermicide, or contraceptive sponge)

inclusion criteria: - signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures. - men and women, ≥18 years of age at time of enrollment. - laboratory-confirmed diagnosis of sars-cov-2 infection as determined by pcr, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if rt-pcr test result not available at the time of screening). - less than or equal to 12 days from covid-19 symptom onset to starting treatment. - symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other covid-19 symptoms as determined by the investigator. - hospitalized for no more than 4 days duration, and: - requiring supplemental oxygen by mask or tongs, or ii) non-invasive ventilation or iii) high-flow oxygen (who category 4 or 5) - female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. male patients must agree to use appropriate contraceptive methods to prevent pregnancy with their partner(s), during the study and up to post 30 days after the last dose of study drug. female patients must be: - unable to have children (e.g., post-menopausal*, bilateral tubal ligation, hysterectomy, bilateral oophorectomy) or where the partner is sterile (e.g., vasectomy) or - willing to remain abstinent (not engage in sexual intercourse for the duration of the screening period and throughout the study, and for 30 days after the last dose) or - willing to use two effective barrier methods of birth control (partner using condom and female using iud, hormonal or nonhormonal contraceptive, diaphragm plus spermicide, or contraceptive sponge)