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

1.Adult male or female subjectâ??s â?¥ 18 years. <br/ >2.Positive for COVID-19 by an approved test (RT PCR). <br/ >3.Subjects with COVID-19 with mild disease and who are at high risk for progressing to severe COVID-19 and/or hospitalization. <br/ >Mild disease defined as upper respiratory tract symptoms &/or fever WITHOUT shortness of breath or hypoxia. (Reference: Clinical guidance for management of adult Covid-19 subjects, Ministry of Health & Family welfare, Government of India, 24 May 2021). <br/ >High risk is defined as: Subjects who meet at least one of the following criteria: <br/ >â?¢Age > 60years OR <br/ >â?¢Cardiovascular disease, hypertension, OR CAD OR <br/ >â?¢DM (Diabetes mellitus) OR other immunocompromised states OR <br/ >â?¢Chronic lung/kidney/liver disease OR <br/ >â?¢Cerebrovascular disease OR <br/ >â?¢Obesity (BMI â?¥ 30 kg/m2) <br/ >4.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study. <br/ >5.Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol. <br/ >6.Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after administration of study dose. <br/ >

1.Adult male or female subjectâ??s â?¥ 18 years. <br/ >2.Positive for COVID-19 by an approved test (RT PCR). <br/ >3.Subjects with COVID-19 with mild disease and who are at high risk for progressing to severe COVID-19 and/or hospitalization. <br/ >Mild disease defined as upper respiratory tract symptoms &/or fever WITHOUT shortness of breath or hypoxia. (Reference: Clinical guidance for management of adult Covid-19 subjects, Ministry of Health & Family welfare, Government of India, 24 May 2021). <br/ >High risk is defined as: Subjects who meet at least one of the following criteria: <br/ >â?¢Age > 60years OR <br/ >â?¢Cardiovascular disease, hypertension, OR CAD OR <br/ >â?¢DM (Diabetes mellitus) OR other immunocompromised states OR <br/ >â?¢Chronic lung/kidney/liver disease OR <br/ >â?¢Cerebrovascular disease OR <br/ >â?¢Obesity (BMI â?¥ 30 kg/m2) <br/ >4.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study. <br/ >5.Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol. <br/ >6.Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after administration of study dose. <br/ >

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

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

1.Adult male or female subjectâ??s â?¥ 18 years. <br/ >2.Positive for COVID-19 by an approved test (RT PCR). <br/ >3.Subjects with COVID-19 with mild disease and who are at high risk for progressing to severe COVID-19 and/or hospitalization. <br/ >Mild disease defined as upper respiratory tract symptoms &/or fever WITHOUT shortness of breath or hypoxia. (Reference: Clinical guidance for management of adult Covid-19 subjects, Ministry of Health & Family welfare, Government of India, 24 May 2021). <br/ >High risk is defined as: Subjects who meet at least one of the following criteria: <br/ >â?¢Age > 60years OR <br/ >â?¢Cardiovascular disease, hypertension, OR CAD OR <br/ >â?¢DM (Diabetes mellitus) OR other immunocompromised states OR <br/ >â?¢Chronic lung/kidney/liver disease OR <br/ >â?¢Cerebrovascular disease OR <br/ >â?¢Obesity (BMI â?¥ 30 kg/m2) <br/ >4.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study. <br/ >5.Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol. <br/ >6.Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after administration of study dose. <br/ >

1.Adult male or female subjectâ??s â?¥ 18 years. <br/ >2.Positive for COVID-19 by an approved test (RT PCR). <br/ >3.Subjects with COVID-19 with mild disease and who are at high risk for progressing to severe COVID-19 and/or hospitalization. <br/ >Mild disease defined as upper respiratory tract symptoms &/or fever WITHOUT shortness of breath or hypoxia. (Reference: Clinical guidance for management of adult Covid-19 subjects, Ministry of Health & Family welfare, Government of India, 24 May 2021). <br/ >High risk is defined as: Subjects who meet at least one of the following criteria: <br/ >â?¢Age > 60years OR <br/ >â?¢Cardiovascular disease, hypertension, OR CAD OR <br/ >â?¢DM (Diabetes mellitus) OR other immunocompromised states OR <br/ >â?¢Chronic lung/kidney/liver disease OR <br/ >â?¢Cerebrovascular disease OR <br/ >â?¢Obesity (BMI â?¥ 30 kg/m2) <br/ >4.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study. <br/ >5.Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol. <br/ >6.Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after administration of study dose. <br/ >