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

inclusion criteria: 1. age ≥18 years or the legal age of consent in the jurisdiction in which the trial was taking place at the time of signing the informed consent (specific for india; age ≥18 to ≤65 years at the time of signing the informed consent) 2. hospitalized due to sars-cov-2 infection confirmed by a hospital-approved polymerase chain reaction (pcr) test, documented by either of the following: 1. pcr positive in sample collected \<72 hours prior to randomization (visit 2); or 2. pcr positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample and progressive disease suggestive of ongoing sars-cov-2 infection 3. a score of 5 or 6 on the 8-point ordinal scale: 1. score 5: hospitalized, requiring supplemental oxygen 2. score 6: hospitalized, on non-invasive ventilation or high-flow oxygen device 4. contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies and according to appendix 3 in the protocol (see section 10.3) 5. written informed consent, consistent with international council for harmonization good clinical practice revision 2 and local laws, obtained before the initiation of any trial-related procedure 6. capable of giving signed informed consent as described in appendix 1 in the protocol (see section 10.1.3) which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol country specific: 7. specific for india: for subjects with an ordinal scale score of 5, moderate to severe covid-19 disease confirmed by at an spo2≤93 % or a respiratory rate≥24/min on room air. note: if a subject was on supplemental oxygen with spo2\>93% and respiratory rate\<24/min, but desaturation to ≤93 % or increase of respiratory rate to ≥24/min on lower supplemental oxygen or room air is documented during screening, the inclusion criterion was considered to be met.

inclusion criteria: 1. age ≥18 years or the legal age of consent in the jurisdiction in which the trial was taking place at the time of signing the informed consent (specific for india; age ≥18 to ≤65 years at the time of signing the informed consent) 2. hospitalized due to sars-cov-2 infection confirmed by a hospital-approved polymerase chain reaction (pcr) test, documented by either of the following: 1. pcr positive in sample collected \<72 hours prior to randomization (visit 2); or 2. pcr positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample and progressive disease suggestive of ongoing sars-cov-2 infection 3. a score of 5 or 6 on the 8-point ordinal scale: 1. score 5: hospitalized, requiring supplemental oxygen 2. score 6: hospitalized, on non-invasive ventilation or high-flow oxygen device 4. contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies and according to appendix 3 in the protocol (see section 10.3) 5. written informed consent, consistent with international council for harmonization good clinical practice revision 2 and local laws, obtained before the initiation of any trial-related procedure 6. capable of giving signed informed consent as described in appendix 1 in the protocol (see section 10.1.3) which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol country specific: 7. specific for india: for subjects with an ordinal scale score of 5, moderate to severe covid-19 disease confirmed by at an spo2≤93 % or a respiratory rate≥24/min on room air. note: if a subject was on supplemental oxygen with spo2\>93% and respiratory rate\<24/min, but desaturation to ≤93 % or increase of respiratory rate to ≥24/min on lower supplemental oxygen or room air is documented during screening, the inclusion criterion was considered to be met.

Dec. 15, 2023, 4 p.m. usa

inclusion criteria: age ≥18 years or the legal age of consent in the jurisdiction in which the trial was taking place at the time of signing the informed consent (specific for india; age ≥18 to ≤65 years at the time of signing the informed consent) hospitalized due to sars-cov-2 infection confirmed by a hospital-approved polymerase chain reaction (pcr) test, documented by either of the following: pcr positive in sample collected <72 hours prior to randomization (visit 2); or pcr positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample and progressive disease suggestive of ongoing sars-cov-2 infection a score of 5 or 6 on the 8-point ordinal scale: score 5: hospitalized, requiring supplemental oxygen score 6: hospitalized, on non-invasive ventilation or high-flow oxygen device contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies and according to appendix 3 in the protocol (see section 10.3) written informed consent, consistent with international council for harmonization good clinical practice revision 2 and local laws, obtained before the initiation of any trial-related procedure capable of giving signed informed consent as described in appendix 1 in the protocol (see section 10.1.3) which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol country specific: specific for india: for subjects with an ordinal scale score of 5, moderate to severe covid-19 disease confirmed by at an spo2≤93 % or a respiratory rate≥24/min on room air. note: if a subject was on supplemental oxygen with spo2>93% and respiratory rate<24/min, but desaturation to ≤93 % or increase of respiratory rate to ≥24/min on lower supplemental oxygen or room air is documented during screening, the inclusion criterion was considered to be met.

inclusion criteria: age ≥18 years or the legal age of consent in the jurisdiction in which the trial was taking place at the time of signing the informed consent (specific for india; age ≥18 to ≤65 years at the time of signing the informed consent) hospitalized due to sars-cov-2 infection confirmed by a hospital-approved polymerase chain reaction (pcr) test, documented by either of the following: pcr positive in sample collected <72 hours prior to randomization (visit 2); or pcr positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample and progressive disease suggestive of ongoing sars-cov-2 infection a score of 5 or 6 on the 8-point ordinal scale: score 5: hospitalized, requiring supplemental oxygen score 6: hospitalized, on non-invasive ventilation or high-flow oxygen device contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies and according to appendix 3 in the protocol (see section 10.3) written informed consent, consistent with international council for harmonization good clinical practice revision 2 and local laws, obtained before the initiation of any trial-related procedure capable of giving signed informed consent as described in appendix 1 in the protocol (see section 10.1.3) which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol country specific: specific for india: for subjects with an ordinal scale score of 5, moderate to severe covid-19 disease confirmed by at an spo2≤93 % or a respiratory rate≥24/min on room air. note: if a subject was on supplemental oxygen with spo2>93% and respiratory rate<24/min, but desaturation to ≤93 % or increase of respiratory rate to ≥24/min on lower supplemental oxygen or room air is documented during screening, the inclusion criterion was considered to be met.

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

inclusion criteria: age ≥18 years or the legal age of consent in the jurisdiction in which the trial is taking place at the time of signing the informed consent hospitalized due to severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection confirmed by polymerase chain reaction test, documented by either of the following: polymerase chain reaction (pcr) positive in sample collected <72 hours prior to randomization (visit 2); or pcr positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample and progressive disease suggestive of ongoing sars-cov-2 infection a score of 5 or 6 on the 8-point ordinal scale: score 5: hospitalized, requiring supplemental oxygen score 6: hospitalized, on non-invasive ventilation or high-flow oxygen device contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies written informed consent, consistent with international council for harmonization good clinical practice revision 2 and local laws, obtained before the initiation of any trial- related procedure capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol

inclusion criteria: age ≥18 years or the legal age of consent in the jurisdiction in which the trial is taking place at the time of signing the informed consent hospitalized due to severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection confirmed by polymerase chain reaction test, documented by either of the following: polymerase chain reaction (pcr) positive in sample collected <72 hours prior to randomization (visit 2); or pcr positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample and progressive disease suggestive of ongoing sars-cov-2 infection a score of 5 or 6 on the 8-point ordinal scale: score 5: hospitalized, requiring supplemental oxygen score 6: hospitalized, on non-invasive ventilation or high-flow oxygen device contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies written informed consent, consistent with international council for harmonization good clinical practice revision 2 and local laws, obtained before the initiation of any trial- related procedure capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol

May 13, 2021, 12:31 a.m. usa

inclusion criteria: 1. age ≥18 years or the legal age of consent in the jurisdiction in which the trial is taking place at the time of signing the informed consent 2. hospitalized due to severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection confirmed by polymerase chain reaction test, documented by either of the following: 1. polymerase chain reaction (pcr) positive in sample collected <72 hours prior to randomization (visit 2); or 2. pcr positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample and progressive disease suggestive of ongoing sars-cov-2 infection 3. a score of 5 or 6 on the 8-point ordinal scale: 1. score 5: hospitalized, requiring supplemental oxygen 2. score 6: hospitalized, on non-invasive ventilation or high-flow oxygen device 4. contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies 5. written informed consent, consistent with international council for harmonization good clinical practice revision 2 and local laws, obtained before the initiation of any trial- related procedure 6. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol

inclusion criteria: 1. age ≥18 years or the legal age of consent in the jurisdiction in which the trial is taking place at the time of signing the informed consent 2. hospitalized due to severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection confirmed by polymerase chain reaction test, documented by either of the following: 1. polymerase chain reaction (pcr) positive in sample collected <72 hours prior to randomization (visit 2); or 2. pcr positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample and progressive disease suggestive of ongoing sars-cov-2 infection 3. a score of 5 or 6 on the 8-point ordinal scale: 1. score 5: hospitalized, requiring supplemental oxygen 2. score 6: hospitalized, on non-invasive ventilation or high-flow oxygen device 4. contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies 5. written informed consent, consistent with international council for harmonization good clinical practice revision 2 and local laws, obtained before the initiation of any trial- related procedure 6. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol