Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

1 Known severe allergic reactions to monoclonal antibodies. <br/ > 2 Has active tuberculosis or known history of inadequately treated tuberculosis or latent tuberculosis(based on the the guidance given in protocol on excluding tuberculosis patients). <br/ > 3 Known active systemic or pulmonary bacterial, fungal or viral (other than SARS-CoV-2) infection at the time of randomisation <br/ > 4 In the opinion of the investigator, progression to death is highly probable, irrespective of the provision of treatments. <br/ > 5 Patient receiving IMV at the time of randomisation or in the opinion of investigator, progression to IMV is highly probable in next 24 hours. <br/ > 6 Patient receiving oral anti-rejection or immune-suppressive drugs regularly in the last 3 months prior to screening. <br/ > 7 Participating in another clinical study of an investigational product and/or received an investigational product within 30 days or within 5 half-lives prior to randomisation. <br/ > 8 Patients treated with IL-6 inhibitors, example: tocilizumab or other biologics with anti-inflammatory action (e.g., TNF-α inhibitors, anti-IL17A) or bevacizumab or JAK inhibitors (e.g. Baricitinib, Tofacitinib) or immunoglobulin for COVID-19 including other immunomodulatory biologic drugs with a positive opinion for emergency use or for compassionate use. <br/ > 9 Requires renal dialysis, either acute or chronic, at the time of randomisation <br/ > 10 Any serious inherited disorder, medical condition or abnormality of clinical laboratory tests that, in the investigatorâ??s judgement, precludes the patientâ??s safe participation in and completion of the study. <br/ > 11 Absolute neutrophil count <1000/mm³ <br/ > 12 Platelet count <50,000/mm³ <br/ > 13 Absolute Lymphocyte count <500/mm³ <br/ >

1 Known severe allergic reactions to monoclonal antibodies. <br/ > 2 Has active tuberculosis or known history of inadequately treated tuberculosis or latent tuberculosis(based on the the guidance given in protocol on excluding tuberculosis patients). <br/ > 3 Known active systemic or pulmonary bacterial, fungal or viral (other than SARS-CoV-2) infection at the time of randomisation <br/ > 4 In the opinion of the investigator, progression to death is highly probable, irrespective of the provision of treatments. <br/ > 5 Patient receiving IMV at the time of randomisation or in the opinion of investigator, progression to IMV is highly probable in next 24 hours. <br/ > 6 Patient receiving oral anti-rejection or immune-suppressive drugs regularly in the last 3 months prior to screening. <br/ > 7 Participating in another clinical study of an investigational product and/or received an investigational product within 30 days or within 5 half-lives prior to randomisation. <br/ > 8 Patients treated with IL-6 inhibitors, example: tocilizumab or other biologics with anti-inflammatory action (e.g., TNF-α inhibitors, anti-IL17A) or bevacizumab or JAK inhibitors (e.g. Baricitinib, Tofacitinib) or immunoglobulin for COVID-19 including other immunomodulatory biologic drugs with a positive opinion for emergency use or for compassionate use. <br/ > 9 Requires renal dialysis, either acute or chronic, at the time of randomisation <br/ > 10 Any serious inherited disorder, medical condition or abnormality of clinical laboratory tests that, in the investigatorâ??s judgement, precludes the patientâ??s safe participation in and completion of the study. <br/ > 11 Absolute neutrophil count <1000/mm³ <br/ > 12 Platelet count <50,000/mm³ <br/ > 13 Absolute Lymphocyte count <500/mm³ <br/ >