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

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 all of the following criteria: <br/ >a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARS-CoV-2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARS-CoV-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 OR continued to be present without improvement OR are aggravated <br/ >AND <br/ >c. Patient meet the below-mentioned criterion (# 3) for â??moderateâ?? COVID-19 disease severity <br/ >3. Patients clinically assigned as â??moderateâ?? (Pneumonia with no signs of severe disease, respiratory rate â?¥24 breaths/minute, SpO2 <94% (90%-94%) on room air) <br/ >Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV). <br/ >4. 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/ >5. Able and willing to provide informed consent <br/ >6. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ >7. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment

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 all of the following criteria: <br/ >a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARS-CoV-2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARS-CoV-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 OR continued to be present without improvement OR are aggravated <br/ >AND <br/ >c. Patient meet the below-mentioned criterion (# 3) for â??moderateâ?? COVID-19 disease severity <br/ >3. Patients clinically assigned as â??moderateâ?? (Pneumonia with no signs of severe disease, respiratory rate â?¥24 breaths/minute, SpO2 <94% (90%-94%) on room air) <br/ >Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV). <br/ >4. 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/ >5. Able and willing to provide informed consent <br/ >6. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ >7. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment

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

Nov. 6, 2020, 11:45 p.m. oms

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 all of the following criteria: <br/ >a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARS-CoV-2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARS-CoV-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 OR continued to be present without improvement OR are aggravated <br/ >AND <br/ >c. Patient meet the below-mentioned criterion (# 3) for â??moderateâ?? COVID-19 disease severity <br/ >3. Patients clinically assigned as â??moderateâ?? (Pneumonia with no signs of severe disease, respiratory rate â?¥24 breaths/minute, SpO2 <94% (90%-94%) on room air) <br/ >Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV). <br/ >4. 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/ >5. Able and willing to provide informed consent <br/ >6. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ >7. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment

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 all of the following criteria: <br/ >a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARS-CoV-2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARS-CoV-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 OR continued to be present without improvement OR are aggravated <br/ >AND <br/ >c. Patient meet the below-mentioned criterion (# 3) for â??moderateâ?? COVID-19 disease severity <br/ >3. Patients clinically assigned as â??moderateâ?? (Pneumonia with no signs of severe disease, respiratory rate â?¥24 breaths/minute, SpO2 <94% (90%-94%) on room air) <br/ >Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV). <br/ >4. 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/ >5. Able and willing to provide informed consent <br/ >6. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ >7. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment

Oct. 26, 2020, 8:29 a.m. oms

Male, female and transgender patients aged â?¥ 18 years and â?¤ 65 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 all of the following criteria: <br/ >a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARS-CoV-2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARS-CoV-2 after previous treatment <br/ >AND <br/ >b. Clinical symptoms associated with COVID-19 (fever, cough, difficulty in breathing, fatigue, body ache, headache, diarrhea, nasal congestion) have either re-appeared after previous treatment OR continued to be present without improvement OR are aggravated <br/ >AND <br/ >c. Patient meet the below-mentioned criterion (# 3) for â??moderateâ?? COVID-19 disease severity <br/ >3. Patients clinically assigned as â??moderateâ?? (Pneumonia with no signs of severe disease, respiratory rate 15 to 30/minute, SpO2 90%-94%) <br/ >Note: The severity is as defined by the Guidance document on appropriate management of suspect/confirmed cases of COVID-19 published by the Ministry of Health & Family Welfare on 07 Apr 2020. <br/ >4. 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/ >5. Able and willing to provide informed consent <br/ >6. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ >7. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment

Male, female and transgender patients aged â?¥ 18 years and â?¤ 65 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 all of the following criteria: <br/ >a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARS-CoV-2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARS-CoV-2 after previous treatment <br/ >AND <br/ >b. Clinical symptoms associated with COVID-19 (fever, cough, difficulty in breathing, fatigue, body ache, headache, diarrhea, nasal congestion) have either re-appeared after previous treatment OR continued to be present without improvement OR are aggravated <br/ >AND <br/ >c. Patient meet the below-mentioned criterion (# 3) for â??moderateâ?? COVID-19 disease severity <br/ >3. Patients clinically assigned as â??moderateâ?? (Pneumonia with no signs of severe disease, respiratory rate 15 to 30/minute, SpO2 90%-94%) <br/ >Note: The severity is as defined by the Guidance document on appropriate management of suspect/confirmed cases of COVID-19 published by the Ministry of Health & Family Welfare on 07 Apr 2020. <br/ >4. 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/ >5. Able and willing to provide informed consent <br/ >6. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ >7. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment