NCT04834908

Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

A Prospective Randomized Multi-center Open Label Phase 1/2 Study to Evaluate the Safety and Efficacy of Equine COVID-19 Antiserum [F(ab')2](BSVEQAb) Plus Standard of Care in Comparison to Standard of Care Alone in COVID-19 RT-PCR Positive Patients

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Bharat Serums and Vaccines Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Prospective, Randomized, Multi-center, Open label, Phase 1/2 study to Evaluate the Safety and Efficacy of Equine COVID-19 Antiserum \[F(ab')2\]. BSV has developed Equine COVID-19 antiserum from horse serum for the use in COVID-19 infection. The indication proposed is to provide passive immunization to the COVID-19 infected patient thereby reducing the viral load and prevention of disease progression. Clinical phase 1 and phase 2 studies have been planned to be conducted. The phase 1 study will be conducted on two dosages to find the safety and tolerability in patients. Based on the results of phase 1 study the phase 2 shall be initiated.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	Equine COVID-19 Antiserum	Equine COVID-19 antiserum is a polyclonal antibody and it contains Equine COVID-19 immune globulin G.
DRUG	Standard of care	Standard of care for COVID 19 infection based on the current guidelines and institutional practice will be provided

Timeline

• Start date: 2021-07-27
• Primary completion: 2022-05-25
• Completion: 2022-05-25
• First posted: 2021-04-08
• Last updated: 2022-10-14

Locations

1 site across 1 country: India