Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

1. Male, female and transgender patients aged â?¥ 18 years <br/ >2. Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab <br/ >Note: A re-treated/ relapsed patient may be enrolled if he/she meets <br/ >all of the following criteria: <br/ >a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARSCoV <br/ >2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARSCoV-2 after previous treatment <br/ >AND <br/ >b. Clinical symptoms associated with COVID-19 (fever, cough, fatigue, shortness of breath, expectoration, myalgia, rhinorrhea, sore throat, diarrhea, anosmia, ageusia) have either re-appeared after previous treatment <br/ >OR continued to be present without improvement OR are aggravated <br/ >c. Patient meet the below-mentioned criterion number 3 for moderate or severe COVID-19 disease severity <br/ >3. Patients clinically assigned as moderate [Presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% range 90-94% on room air, Respiratory Rate more or equal to 24 per minute] or severe (Clinical signs of Pneumonia plus one of the following, respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air) but not critically ill (acute respiratory distress syndrome [ARDS], multi organ failure or septic shock) <br/ >4. Patients with a score of â?¥ 5 (â??hospitalized, on oxygenâ??) on the 10- point ordinal scale of clinical status used by WHO in the SOLIDARITY trial at baseline assessment. <br/ >5. Females should have a negative serum pregnancy test at baseline, female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment <br/ >6. Able and willing to provide informed consent <br/ >7. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ >8. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment <br/ >

1. Male, female and transgender patients aged â?¥ 18 years <br/ >2. Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab <br/ >Note: A re-treated/ relapsed patient may be enrolled if he/she meets <br/ >all of the following criteria: <br/ >a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARSCoV <br/ >2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARSCoV-2 after previous treatment <br/ >AND <br/ >b. Clinical symptoms associated with COVID-19 (fever, cough, fatigue, shortness of breath, expectoration, myalgia, rhinorrhea, sore throat, diarrhea, anosmia, ageusia) have either re-appeared after previous treatment <br/ >OR continued to be present without improvement OR are aggravated <br/ >c. Patient meet the below-mentioned criterion number 3 for moderate or severe COVID-19 disease severity <br/ >3. Patients clinically assigned as moderate [Presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% range 90-94% on room air, Respiratory Rate more or equal to 24 per minute] or severe (Clinical signs of Pneumonia plus one of the following, respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air) but not critically ill (acute respiratory distress syndrome [ARDS], multi organ failure or septic shock) <br/ >4. Patients with a score of â?¥ 5 (â??hospitalized, on oxygenâ??) on the 10- point ordinal scale of clinical status used by WHO in the SOLIDARITY trial at baseline assessment. <br/ >5. Females should have a negative serum pregnancy test at baseline, female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment <br/ >6. Able and willing to provide informed consent <br/ >7. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ >8. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment <br/ >

Nov. 13, 2021, 5:33 p.m. oms

Jan. 15, 2021, 12:45 a.m. oms

1. Male, female and transgender patients aged â?¥ 18 years <br/ >2. Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab <br/ >Note: A re-treated/ relapsed patient may be enrolled if he/she meets <br/ >all of the following criteria: <br/ >a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARSCoV <br/ >2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARSCoV-2 after previous treatment <br/ >AND <br/ >b. Clinical symptoms associated with COVID-19 (fever, cough, fatigue, shortness of breath, expectoration, myalgia, rhinorrhea, sore throat, diarrhea, anosmia, ageusia) have either re-appeared after previous treatment <br/ >OR continued to be present without improvement OR are aggravated <br/ >c. Patient meet the below-mentioned criterion number 3 for moderate or severe COVID-19 disease severity <br/ >3. Patients clinically assigned as moderate [Presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% range 90-94% on room air, Respiratory Rate more or equal to 24 per minute] or severe (Clinical signs of Pneumonia plus one of the following, respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air) but not critically ill (acute respiratory distress syndrome [ARDS], multi organ failure or septic shock) <br/ >4. Patients with a score of â?¥ 5 (â??hospitalized, on oxygenâ??) on the 10- point ordinal scale of clinical status used by WHO in the SOLIDARITY trial at baseline assessment. <br/ >5. Females should have a negative serum pregnancy test at baseline, female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment <br/ >6. Able and willing to provide informed consent <br/ >7. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ >8. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment <br/ >

1. Male, female and transgender patients aged â?¥ 18 years <br/ >2. Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab <br/ >Note: A re-treated/ relapsed patient may be enrolled if he/she meets <br/ >all of the following criteria: <br/ >a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARSCoV <br/ >2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARSCoV-2 after previous treatment <br/ >AND <br/ >b. Clinical symptoms associated with COVID-19 (fever, cough, fatigue, shortness of breath, expectoration, myalgia, rhinorrhea, sore throat, diarrhea, anosmia, ageusia) have either re-appeared after previous treatment <br/ >OR continued to be present without improvement OR are aggravated <br/ >c. Patient meet the below-mentioned criterion number 3 for moderate or severe COVID-19 disease severity <br/ >3. Patients clinically assigned as moderate [Presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% range 90-94% on room air, Respiratory Rate more or equal to 24 per minute] or severe (Clinical signs of Pneumonia plus one of the following, respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air) but not critically ill (acute respiratory distress syndrome [ARDS], multi organ failure or septic shock) <br/ >4. Patients with a score of â?¥ 5 (â??hospitalized, on oxygenâ??) on the 10- point ordinal scale of clinical status used by WHO in the SOLIDARITY trial at baseline assessment. <br/ >5. Females should have a negative serum pregnancy test at baseline, female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment <br/ >6. Able and willing to provide informed consent <br/ >7. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ >8. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment <br/ >