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

inclusion criteria: * must be willing and able to give informed consent to participate in the study * has admitted to a hospital and has a positive severe acute respiratory syndrome coronavirus 2 (sars-cov-2) test by standard reverse transcription-polymerase chain reaction (rt-pcr) assay or equivalent test * has the presence of any symptom(s) suggestive of moderate or severe systemic illness with covid-19 on day 1 such as the presence of fever (greater than or equal to (\>=)38.0 degree celsius \[\>=100.4 degree fahrenheit\] by any route), "feeling hot," "feeling sweaty," headache, malaise, fatigue, muscle pain, diarrhea, nausea, vomiting, cough, sore throat, or shortness of breath upon exertion and/or at rest, or respiratory distress * has the presence of moderate to severe clinical signs indicative of moderate or severe illness with covid-19 on day 1. a. moderate: (1) clinical signs suggestive of moderate illness with covid-19, such as respiratory rate \>=20 breaths per minute, spo2 \>93% on room air at sea level, heart rate \>=90 beats per minute. (2) no clinical signs indicative of severe or critical covid-19. b. severe: (1) clinical signs suggestive of severe systemic illness with covid-19, such as respiratory rate \>=30 breaths per minute, heart rate \>=125 beats per minute, spo2 less than or equal to (\<=) 93% on room air at sea level or partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) less than (\<)300, heart rate \>=125 beats per minute. (2) no criteria met for critical covid-19 * has either normal renal function or mild or moderate renal impairment: estimated creatinine clearance \>30 milliliters per minute (ml/min) on day 1 * able to swallow the study drug (tablets) * men whose sexual partners are women of childbearing potential (wocbp) must agree to comply with one of the following contraception requirements from the time of first dose of study medication (day 1) until at least 30 days after the last dose of study medication: (a) vasectomy with documentation of azoospermia. (b) sexual abstinence. (c) male condom plus partner use of one of the contraceptive * wocbp must agree to comply with one of the following contraception requirements from the time of first dose of study medication (day 1) until at least 30 days after the last dose of study medication: (a) sexual abstinence (b) use of one of the contraceptive options (c) vasectomy of male partner with documentation of azoospermia

inclusion criteria: * must be willing and able to give informed consent to participate in the study * has admitted to a hospital and has a positive severe acute respiratory syndrome coronavirus 2 (sars-cov-2) test by standard reverse transcription-polymerase chain reaction (rt-pcr) assay or equivalent test * has the presence of any symptom(s) suggestive of moderate or severe systemic illness with covid-19 on day 1 such as the presence of fever (greater than or equal to (\>=)38.0 degree celsius \[\>=100.4 degree fahrenheit\] by any route), "feeling hot," "feeling sweaty," headache, malaise, fatigue, muscle pain, diarrhea, nausea, vomiting, cough, sore throat, or shortness of breath upon exertion and/or at rest, or respiratory distress * has the presence of moderate to severe clinical signs indicative of moderate or severe illness with covid-19 on day 1. a. moderate: (1) clinical signs suggestive of moderate illness with covid-19, such as respiratory rate \>=20 breaths per minute, spo2 \>93% on room air at sea level, heart rate \>=90 beats per minute. (2) no clinical signs indicative of severe or critical covid-19. b. severe: (1) clinical signs suggestive of severe systemic illness with covid-19, such as respiratory rate \>=30 breaths per minute, heart rate \>=125 beats per minute, spo2 less than or equal to (\<=) 93% on room air at sea level or partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) less than (\<)300, heart rate \>=125 beats per minute. (2) no criteria met for critical covid-19 * has either normal renal function or mild or moderate renal impairment: estimated creatinine clearance \>30 milliliters per minute (ml/min) on day 1 * able to swallow the study drug (tablets) * men whose sexual partners are women of childbearing potential (wocbp) must agree to comply with one of the following contraception requirements from the time of first dose of study medication (day 1) until at least 30 days after the last dose of study medication: (a) vasectomy with documentation of azoospermia. (b) sexual abstinence. (c) male condom plus partner use of one of the contraceptive * wocbp must agree to comply with one of the following contraception requirements from the time of first dose of study medication (day 1) until at least 30 days after the last dose of study medication: (a) sexual abstinence (b) use of one of the contraceptive options (c) vasectomy of male partner with documentation of azoospermia

Nov. 7, 2020, 11:31 p.m. usa

inclusion criteria: - must be willing and able to give informed consent to participate in the study - has admitted to a hospital and has a positive severe acute respiratory syndrome coronavirus 2 (sars-cov-2) test by standard reverse transcription-polymerase chain reaction (rt-pcr) assay or equivalent test - has the presence of any symptom(s) suggestive of moderate or severe systemic illness with covid-19 on day 1 such as the presence of fever (greater than or equal to (>=)38.0 degree celsius [>=100.4 degree fahrenheit] by any route), "feeling hot," "feeling sweaty," headache, malaise, fatigue, muscle pain, diarrhea, nausea, vomiting, cough, sore throat, or shortness of breath upon exertion and/or at rest, or respiratory distress - has the presence of moderate to severe clinical signs indicative of moderate or severe illness with covid-19 on day 1. a. moderate: (1) clinical signs suggestive of moderate illness with covid-19, such as respiratory rate >=20 breaths per minute, spo2 >93% on room air at sea level, heart rate >=90 beats per minute. (2) no clinical signs indicative of severe or critical covid-19. b. severe: (1) clinical signs suggestive of severe systemic illness with covid-19, such as respiratory rate >=30 breaths per minute, heart rate >=125 beats per minute, spo2 less than or equal to (<=) 93% on room air at sea level or partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) less than (<)300, heart rate >=125 beats per minute. (2) no criteria met for critical covid-19 - has either normal renal function or mild or moderate renal impairment: estimated creatinine clearance >30 milliliters per minute (ml/min) on day 1 - able to swallow the study drug (tablets) - men whose sexual partners are women of childbearing potential (wocbp) must agree to comply with one of the following contraception requirements from the time of first dose of study medication (day 1) until at least 30 days after the last dose of study medication: (a) vasectomy with documentation of azoospermia. (b) sexual abstinence. (c) male condom plus partner use of one of the contraceptive - wocbp must agree to comply with one of the following contraception requirements from the time of first dose of study medication (day 1) until at least 30 days after the last dose of study medication: (a) sexual abstinence (b) use of one of the contraceptive options (c) vasectomy of male partner with documentation of azoospermia

inclusion criteria: - must be willing and able to give informed consent to participate in the study - has admitted to a hospital and has a positive severe acute respiratory syndrome coronavirus 2 (sars-cov-2) test by standard reverse transcription-polymerase chain reaction (rt-pcr) assay or equivalent test - has the presence of any symptom(s) suggestive of moderate or severe systemic illness with covid-19 on day 1 such as the presence of fever (greater than or equal to (>=)38.0 degree celsius [>=100.4 degree fahrenheit] by any route), "feeling hot," "feeling sweaty," headache, malaise, fatigue, muscle pain, diarrhea, nausea, vomiting, cough, sore throat, or shortness of breath upon exertion and/or at rest, or respiratory distress - has the presence of moderate to severe clinical signs indicative of moderate or severe illness with covid-19 on day 1. a. moderate: (1) clinical signs suggestive of moderate illness with covid-19, such as respiratory rate >=20 breaths per minute, spo2 >93% on room air at sea level, heart rate >=90 beats per minute. (2) no clinical signs indicative of severe or critical covid-19. b. severe: (1) clinical signs suggestive of severe systemic illness with covid-19, such as respiratory rate >=30 breaths per minute, heart rate >=125 beats per minute, spo2 less than or equal to (<=) 93% on room air at sea level or partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) less than (<)300, heart rate >=125 beats per minute. (2) no criteria met for critical covid-19 - has either normal renal function or mild or moderate renal impairment: estimated creatinine clearance >30 milliliters per minute (ml/min) on day 1 - able to swallow the study drug (tablets) - men whose sexual partners are women of childbearing potential (wocbp) must agree to comply with one of the following contraception requirements from the time of first dose of study medication (day 1) until at least 30 days after the last dose of study medication: (a) vasectomy with documentation of azoospermia. (b) sexual abstinence. (c) male condom plus partner use of one of the contraceptive - wocbp must agree to comply with one of the following contraception requirements from the time of first dose of study medication (day 1) until at least 30 days after the last dose of study medication: (a) sexual abstinence (b) use of one of the contraceptive options (c) vasectomy of male partner with documentation of azoospermia