drugset / Trial / NCT04834908

Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

NCT04834908 ↗

Phase 1/2 Terminated 7 enrolled Bharat Serums and Vaccines Limited
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-07-27
Primary completion
2022-05-25
Completion
2022-05-25

Outcome

Outcome not reported

Stopped: “Closed as no eligible patient.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Equine COVID-19 Antiserum Protein / enzyme biologic 5 mg/kg Intravenous
Subject Equine COVID-19 Antiserum Protein / enzyme biologic 10 mg/kg Intravenous

Indications