Effect of SARS-CoV-2 Equine Antiserum Immunoglobulin (Purified F(ab)2 fragment) in hospitalised COVID-19 patients with moderate disease

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: Intervention1: SARS‐CoV‐2 (COVID‐19) Antiserum Immunoglobulins (Purified F(ab)2 fragment along with standard of care: Patients in this group will receive two 4mL doses (at day 0 and Day 1) of BioEâ??s SARS‐CoV‐2 (COVID‐19) Antiserum Immunoglobulins (Purified F(ab)2 fragment) intravenously along with standard of care. Control Intervention1: Standard care for Covid‐19 patients: Patients in this group will receive only standard of care for Covid‐19 patients. CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: Proportion of patients with treatment‐emergent adverse events including infusion related reactionsTimepoint: Day 0 Through Day 28 SECONDARY OUTCOME: All cause mortality rateTimepoint: at Day 28. Change in oxygen requirementTimepoint: Post Infusion Duration of respiratory support required ; a. Duration of Invasive Mechanical Ventilation ; b. Duration of Non‐Invasive VentilationTimepoint: Post Enrolment Levels of bio‐markers (CRP, IL6, LDH, Ferritin & D‐Dimer)Timepoint: pre and post ; infusion Proportion of patients with clinical progression of disease on a WHO ; clinical progression scaleTimepoint: assessed up to Day 28. Proportion of patients with RT‐PCR negative outcomeTimepoint: At Day 14 and Day 28 Time to symptom resolution ; a) Fever ; b) Shortness of Breath ; c) FatigueTimepoint: post enrolment INCLUSION CRITERIA: 1. Both male and female patients aged between 18‐55 years who signed the informed consent. 2. Patients screened for Covid‐19 by RT‐PCR method â?¤72 hours from the date of RT‐PCR confirmation and/or 7 days from the start of symptoms. 3. Respiratory Rate > 24 breaths/min and SpO2 â?¤93% on room air 4. Patients screened for intradermal sensitivity testing prior to initiation of infusion.
Epistemonikos ID: 7c6dac293ac789eca54e04ed333c5ca332b92992
First added on: Dec 05, 2020