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

inclusion criteria: 1. provide informed consent 2. be able to communicate effectively with the study personnel 3. aged ≥18 years 4. severe acute respiratory syndrome coronavirus (sars-cov-2) infection confirmed by polymerase chain reaction (pcr) test 5. patients at high risk for ards, with known comorbidities for being at high risk, such as, asthma (moderate to severe), chronic lung disease, diabetes, chronic kidney disease being treated with dialysis, severe obesity (bmi ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, immunocompromised 6. peripheral capillary oxygen saturation (spo2) ≤ 94% on room air at screening 7. subjects must agree to use acceptable methods of contraception * if subject is female or the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. acceptable methods of contraception are as follows: condom with spermicidal foam/gel/film/cream/suppository \[i.e., barrier method of contraception\], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) * if female subject or the female partner of a male subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used * if female subject or the female partner of a male subject has undergone documented placement of an intrauterine device (iud) or intrauterine system (ius), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used 8. subject is willing to comply with the requirements of the protocol through the end of the study

inclusion criteria: 1. provide informed consent 2. be able to communicate effectively with the study personnel 3. aged ≥18 years 4. severe acute respiratory syndrome coronavirus (sars-cov-2) infection confirmed by polymerase chain reaction (pcr) test 5. patients at high risk for ards, with known comorbidities for being at high risk, such as, asthma (moderate to severe), chronic lung disease, diabetes, chronic kidney disease being treated with dialysis, severe obesity (bmi ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, immunocompromised 6. peripheral capillary oxygen saturation (spo2) ≤ 94% on room air at screening 7. subjects must agree to use acceptable methods of contraception * if subject is female or the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. acceptable methods of contraception are as follows: condom with spermicidal foam/gel/film/cream/suppository \[i.e., barrier method of contraception\], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) * if female subject or the female partner of a male subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used * if female subject or the female partner of a male subject has undergone documented placement of an intrauterine device (iud) or intrauterine system (ius), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used 8. subject is willing to comply with the requirements of the protocol through the end of the study

Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: provide informed consent be able to communicate effectively with the study personnel aged ≥18 years severe acute respiratory syndrome coronavirus (sars-cov-2) infection confirmed by polymerase chain reaction (pcr) test patients at high risk for ards, with known comorbidities for being at high risk, such as, asthma (moderate to severe), chronic lung disease, diabetes, chronic kidney disease being treated with dialysis, severe obesity (bmi ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, immunocompromised peripheral capillary oxygen saturation (spo2) ≤ 94% on room air at screening subjects must agree to use acceptable methods of contraception if subject is female or the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. acceptable methods of contraception are as follows: condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) if female subject or the female partner of a male subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used if female subject or the female partner of a male subject has undergone documented placement of an intrauterine device (iud) or intrauterine system (ius), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used subject is willing to comply with the requirements of the protocol through the end of the study

inclusion criteria: provide informed consent be able to communicate effectively with the study personnel aged ≥18 years severe acute respiratory syndrome coronavirus (sars-cov-2) infection confirmed by polymerase chain reaction (pcr) test patients at high risk for ards, with known comorbidities for being at high risk, such as, asthma (moderate to severe), chronic lung disease, diabetes, chronic kidney disease being treated with dialysis, severe obesity (bmi ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, immunocompromised peripheral capillary oxygen saturation (spo2) ≤ 94% on room air at screening subjects must agree to use acceptable methods of contraception if subject is female or the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. acceptable methods of contraception are as follows: condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) if female subject or the female partner of a male subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used if female subject or the female partner of a male subject has undergone documented placement of an intrauterine device (iud) or intrauterine system (ius), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used subject is willing to comply with the requirements of the protocol through the end of the study

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

inclusion criteria: 1. provide informed consent 2. be able to communicate effectively with the study personnel 3. aged ≥18 years 4. severe acute respiratory syndrome coronavirus (sars-cov-2) infection confirmed by polymerase chain reaction (pcr) test 5. patients at high risk for ards, with known comorbidities for being at high risk, such as, asthma (moderate to severe), chronic lung disease, diabetes, chronic kidney disease being treated with dialysis, severe obesity (bmi ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, immunocompromised 6. peripheral capillary oxygen saturation (spo2) ≤ 94% on room air at screening 7. subjects must agree to use acceptable methods of contraception - if subject is female or the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. acceptable methods of contraception are as follows: condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) - if female subject or the female partner of a male subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used - if female subject or the female partner of a male subject has undergone documented placement of an intrauterine device (iud) or intrauterine system (ius), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used 8. subject is willing to comply with the requirements of the protocol through the end of the study

inclusion criteria: 1. provide informed consent 2. be able to communicate effectively with the study personnel 3. aged ≥18 years 4. severe acute respiratory syndrome coronavirus (sars-cov-2) infection confirmed by polymerase chain reaction (pcr) test 5. patients at high risk for ards, with known comorbidities for being at high risk, such as, asthma (moderate to severe), chronic lung disease, diabetes, chronic kidney disease being treated with dialysis, severe obesity (bmi ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, immunocompromised 6. peripheral capillary oxygen saturation (spo2) ≤ 94% on room air at screening 7. subjects must agree to use acceptable methods of contraception - if subject is female or the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. acceptable methods of contraception are as follows: condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) - if female subject or the female partner of a male subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used - if female subject or the female partner of a male subject has undergone documented placement of an intrauterine device (iud) or intrauterine system (ius), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used 8. subject is willing to comply with the requirements of the protocol through the end of the study