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

Phase 1

Active, not recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/11/028779
• Lead Sponsor: Biological ELimited

Brief Summary

This is an open label, randomised controlled phase-I study to evaluate the safety and efficacy of 4.0 mL intravenous dose of Equine antisera Immunoglobulin (Purified F(ab’)2 fragment) against SARS-CoV-2 administered in two doses, 24 hours apart, in 18-55 year-old hospitalised patients suffering from moderate Covid-19 disease.



A total of 72 eligible patients suffering from moderate Covid-19 disease will be equally randomised into one of the two treatment arms based on the screening and enrolment criteria set in the protocol. The patients in both the arms, will receive standard of care for Covid-19 and the patients in Equine antisera arm would additionally receive two 4mL intravenous doses (2 vials x 2mL each) of SARS-CoV-2 (COVID-19) Antiserum Immunoglobulins (Purified F(ab’)2 fragment) 24hrs apart for assessing the safety & efficacy.



The total duration of the study will be 31 days (3 days for screening + 28 days for post immunoglobulin infusion.The study will be conducted in compliance with GSR 227(E),ICH and Indian good clinical practice guidelines in force at the time of studyconduct.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-11
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Both male and female patients aged between 18-55 years who signed the informed consent.
• Patients screened for Covid-19 by RT-PCR method ≤72 hours from the date of RT-PCR confirmation and/or 7 days from the start of symptoms.
• Respiratory Rate > 24 breaths/min and SpO2 ≤93% on room air 4.

Exclusion Criteria

• 1.Pregnant women 2.
• Breastfeeding women 3.
• Known hypersensitivity to blood products and reactive to intradermal sensitivity test prior to infusion 4.
• Receipt of pooled immunoglobulin in last 30 days 5.
• Critically ill patients: a.
• Severe ARDS cases b.
• Shock (Requiring Vasopressor to maintain a MAP ≥ 65mmHg or MAP below 65) 6.
• Participating in any other clinical trial 7.
• Clinical status precluding infusion of blood products 8.
• Patients are not suitable for transfusion therapy; 9.
• Patients with severe pneumonia defined as: RR ≥30 times/min or oxygen saturation ≤ 90% in resting state or PaO2/FiO2 ≤ 100 mmHg or respiratory failure and mechanical ventilation are required or shock occurs or ICU monitoring with presence of other organ failure; 10.
• Acute life-threatening organ dysfunction caused by a dys-regulated host response to suspected or proven infection.
• (Signs of organ dysfunction include: altered mental status, difficult or fast breathing, low oxygen saturation, reduced urine output, fast heart rate, weak pulse, cold extremities or low blood pressure, skin mottling, or laboratory evidence of coagulopathy, thrombocytopenia, acidosis, high lactate or hyperbilirubinemia).
• Patients on any other immunoglobulin or immunomodulatory treatment; 12.
• Patients with known history of allergy to horse proteins or severe allergic reactions to any component of the Equine antiserum;.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with treatment-emergent adverse events including infusion related reactions	Day 0 Through Day 28

Secondary Outcome Measures

Name	Time	Method
Time to symptom resolution	a) Fever
Proportion of patients with clinical progression of disease on a WHO	clinical progression scale
Proportion of patients with RT-PCR negative outcome	At Day 14 and Day 28
Change in oxygen requirement	Post Infusion
Duration of respiratory support required	a. Duration of Invasive Mechanical Ventilation
Levels of bio-markers (CRP, IL6, LDH, Ferritin & D-Dimer)	pre and post
All cause mortality rate	at Day 28.

Trial Locations

Locations (2)

All India Institute of Medical Sciences; 🇮🇳 Patna, BIHAR, India

Visakha Institute of Medical Sciences(VIMS); 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

All India Institute of Medical Sciences

🇮🇳Patna, BIHAR, India

Dr Chandramani Singh

Principal investigator

09931733280

drcmsingh@aiimspatna.org