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

1.Evidence of moderate or severe COVID-19 disease as per the Clinical guidance for management of adult Covid-19 subjects, Ministry of Health & Family welfare, Government of India, 17 May 2021. <br/ >(Moderate disease: Any one of (1) Respiratory rate â?¥ 24/min, breathlessness, (2) SpO2 90% to â?¤ 93% on room air) <br/ >(Severe disease: Any one of (1) Respiratory rate >30/min, breathlessness, (2) SpO2 < 90% on room air) <br/ >2.Onset of COVID-19 symptoms before 5 days from planned study drug administration. <br/ >3.Current hospitalization due to COVID at the time of screening. <br/ >4.Has a documented infection other than COVID-19. <br/ >5.Has received a COVID-19 vaccine (For Phase 2: However, vaccinated subjects who are infected can be enrolled based on a case by case basis). <br/ >6.Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. <br/ >7.Has a history of hypersensitivity reactions to therapeutic proteins. <br/ >8.Pregnant or lactating and breast feeding or planning on either during the study. <br/ >

1.Evidence of moderate or severe COVID-19 disease as per the Clinical guidance for management of adult Covid-19 subjects, Ministry of Health & Family welfare, Government of India, 17 May 2021. <br/ >(Moderate disease: Any one of (1) Respiratory rate â?¥ 24/min, breathlessness, (2) SpO2 90% to â?¤ 93% on room air) <br/ >(Severe disease: Any one of (1) Respiratory rate >30/min, breathlessness, (2) SpO2 < 90% on room air) <br/ >2.Onset of COVID-19 symptoms before 5 days from planned study drug administration. <br/ >3.Current hospitalization due to COVID at the time of screening. <br/ >4.Has a documented infection other than COVID-19. <br/ >5.Has received a COVID-19 vaccine (For Phase 2: However, vaccinated subjects who are infected can be enrolled based on a case by case basis). <br/ >6.Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. <br/ >7.Has a history of hypersensitivity reactions to therapeutic proteins. <br/ >8.Pregnant or lactating and breast feeding or planning on either during the study. <br/ >

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

N/A

N/A

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

1.Evidence of moderate or severe COVID-19 disease as per the Clinical guidance for management of adult Covid-19 subjects, Ministry of Health & Family welfare, Government of India, 17 May 2021. <br/ >(Moderate disease: Any one of (1) Respiratory rate â?¥ 24/min, breathlessness, (2) SpO2 90% to â?¤ 93% on room air) <br/ >(Severe disease: Any one of (1) Respiratory rate >30/min, breathlessness, (2) SpO2 < 90% on room air) <br/ >2.Onset of COVID-19 symptoms before 5 days from planned study drug administration. <br/ >3.Current hospitalization due to COVID at the time of screening. <br/ >4.Has a documented infection other than COVID-19. <br/ >5.Has received a COVID-19 vaccine (For Phase 2: However, vaccinated subjects who are infected can be enrolled based on a case by case basis). <br/ >6.Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. <br/ >7.Has a history of hypersensitivity reactions to therapeutic proteins. <br/ >8.Pregnant or lactating and breast feeding or planning on either during the study. <br/ >

1.Evidence of moderate or severe COVID-19 disease as per the Clinical guidance for management of adult Covid-19 subjects, Ministry of Health & Family welfare, Government of India, 17 May 2021. <br/ >(Moderate disease: Any one of (1) Respiratory rate â?¥ 24/min, breathlessness, (2) SpO2 90% to â?¤ 93% on room air) <br/ >(Severe disease: Any one of (1) Respiratory rate >30/min, breathlessness, (2) SpO2 < 90% on room air) <br/ >2.Onset of COVID-19 symptoms before 5 days from planned study drug administration. <br/ >3.Current hospitalization due to COVID at the time of screening. <br/ >4.Has a documented infection other than COVID-19. <br/ >5.Has received a COVID-19 vaccine (For Phase 2: However, vaccinated subjects who are infected can be enrolled based on a case by case basis). <br/ >6.Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. <br/ >7.Has a history of hypersensitivity reactions to therapeutic proteins. <br/ >8.Pregnant or lactating and breast feeding or planning on either during the study. <br/ >