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

1. Male and/or female patients aged â?¥ 18 and â?¤ 60 years of age (both inclusive). <br/ >2. Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent. <br/ >3. Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization. <br/ >4. Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization. <br/ >a. Respiratory rate â?¥ 24/min, breathlessness <br/ >b. SpO2: 90% to â?¤ 93% on room air <br/ >5. Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on). <br/ >6. Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit. <br/ >7. Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization. <br/ > Medically acceptable forms of contraceptive include: <br/ >a. Hormonal contraceptives (at least 1 month before screening visit) <br/ >b. Double barrier methods (e.g., diaphragm with spermicide, or condoms with spermicide) <br/ >c. Intrauterine device (IUD) <br/ >

1. Male and/or female patients aged â?¥ 18 and â?¤ 60 years of age (both inclusive). <br/ >2. Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent. <br/ >3. Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization. <br/ >4. Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization. <br/ >a. Respiratory rate â?¥ 24/min, breathlessness <br/ >b. SpO2: 90% to â?¤ 93% on room air <br/ >5. Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on). <br/ >6. Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit. <br/ >7. Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization. <br/ > Medically acceptable forms of contraceptive include: <br/ >a. Hormonal contraceptives (at least 1 month before screening visit) <br/ >b. Double barrier methods (e.g., diaphragm with spermicide, or condoms with spermicide) <br/ >c. Intrauterine device (IUD) <br/ >

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

Sept. 8, 2021, 1:30 a.m. oms

1. Male and/or female patients aged â?¥ 18 and â?¤ 60 years of age (both inclusive). <br/ >2. Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent. <br/ >3. Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization. <br/ >4. Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization. <br/ >a. Respiratory rate â?¥ 24/min, breathlessness <br/ >b. SpO2: 90% to â?¤ 93% on room air <br/ >5. Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on). <br/ >6. Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit. <br/ >7. Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization. <br/ > Medically acceptable forms of contraceptive include: <br/ >a. Hormonal contraceptives (at least 1 month before screening visit) <br/ >b. Double barrier methods (e.g., diaphragm with spermicide, or condoms with spermicide) <br/ >c. Intrauterine device (IUD) <br/ >

1. Male and/or female patients aged â?¥ 18 and â?¤ 60 years of age (both inclusive). <br/ >2. Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent. <br/ >3. Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization. <br/ >4. Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization. <br/ >a. Respiratory rate â?¥ 24/min, breathlessness <br/ >b. SpO2: 90% to â?¤ 93% on room air <br/ >5. Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on). <br/ >6. Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit. <br/ >7. Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization. <br/ > Medically acceptable forms of contraceptive include: <br/ >a. Hormonal contraceptives (at least 1 month before screening visit) <br/ >b. Double barrier methods (e.g., diaphragm with spermicide, or condoms with spermicide) <br/ >c. Intrauterine device (IUD) <br/ >