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

1.Subjects with known hypersensitivity to any of the components of the formulation and/ or with prior allergic reaction due to contact or exposure to horses <br/ >2.Subjects of COVID-19 disease, less than 18 years old <br/ >3.History of anaphylaxis <br/ >4.History of prior administration of equine serum (for example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) <br/ >5.Subjects who have received or require treatment with convalescent plasma. <br/ >6.Severe COVID-19 disease, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ >7.Other disease conditions: <br/ >i.Medical history of Oncological Conditions since last 2 years <br/ >ii.Known severe renal impairment, known case of asthma or chronic obstructive lung disease. <br/ >iii.Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) elevated over 5 times the Upper Limit of Normal (ULN) <br/ >8.Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of hospital admission. <br/ >9.Medical conditions that would limit subjectâ??s participation in the study as per Investigatorâ??s judgement. <br/ >10.Females - Pregnant or lactating and/ or planning to conceive during the trial period. <br/ >11.Subjects with autoimmune disease in the past, tested positive for human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C. <br/ >12.Receipt of pooled immunoglobulin in last 90 days

1.Subjects with known hypersensitivity to any of the components of the formulation and/ or with prior allergic reaction due to contact or exposure to horses <br/ >2.Subjects of COVID-19 disease, less than 18 years old <br/ >3.History of anaphylaxis <br/ >4.History of prior administration of equine serum (for example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) <br/ >5.Subjects who have received or require treatment with convalescent plasma. <br/ >6.Severe COVID-19 disease, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ >7.Other disease conditions: <br/ >i.Medical history of Oncological Conditions since last 2 years <br/ >ii.Known severe renal impairment, known case of asthma or chronic obstructive lung disease. <br/ >iii.Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) elevated over 5 times the Upper Limit of Normal (ULN) <br/ >8.Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of hospital admission. <br/ >9.Medical conditions that would limit subjectâ??s participation in the study as per Investigatorâ??s judgement. <br/ >10.Females - Pregnant or lactating and/ or planning to conceive during the trial period. <br/ >11.Subjects with autoimmune disease in the past, tested positive for human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C. <br/ >12.Receipt of pooled immunoglobulin in last 90 days

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

N/A

N/A

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

1.Subjects with known hypersensitivity to any of the components of the formulation and/ or with prior allergic reaction due to contact or exposure to horses <br/ >2.Subjects of COVID-19 disease, less than 18 years old <br/ >3.History of anaphylaxis <br/ >4.History of prior administration of equine serum (for example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) <br/ >5.Subjects who have received or require treatment with convalescent plasma. <br/ >6.Severe COVID-19 disease, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ >7.Other disease conditions: <br/ >i.Medical history of Oncological Conditions since last 2 years <br/ >ii.Known severe renal impairment, known case of asthma or chronic obstructive lung disease. <br/ >iii.Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) elevated over 5 times the Upper Limit of Normal (ULN) <br/ >8.Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of hospital admission. <br/ >9.Medical conditions that would limit subjectâ??s participation in the study as per Investigatorâ??s judgement. <br/ >10.Females - Pregnant or lactating and/ or planning to conceive during the trial period. <br/ >11.Subjects with autoimmune disease in the past, tested positive for human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C. <br/ >12.Receipt of pooled immunoglobulin in last 90 days

1.Subjects with known hypersensitivity to any of the components of the formulation and/ or with prior allergic reaction due to contact or exposure to horses <br/ >2.Subjects of COVID-19 disease, less than 18 years old <br/ >3.History of anaphylaxis <br/ >4.History of prior administration of equine serum (for example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) <br/ >5.Subjects who have received or require treatment with convalescent plasma. <br/ >6.Severe COVID-19 disease, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ >7.Other disease conditions: <br/ >i.Medical history of Oncological Conditions since last 2 years <br/ >ii.Known severe renal impairment, known case of asthma or chronic obstructive lung disease. <br/ >iii.Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) elevated over 5 times the Upper Limit of Normal (ULN) <br/ >8.Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of hospital admission. <br/ >9.Medical conditions that would limit subjectâ??s participation in the study as per Investigatorâ??s judgement. <br/ >10.Females - Pregnant or lactating and/ or planning to conceive during the trial period. <br/ >11.Subjects with autoimmune disease in the past, tested positive for human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C. <br/ >12.Receipt of pooled immunoglobulin in last 90 days