drugset / Trial / NCT04834908
Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Equine COVID-19 Antiserum | Protein / enzyme biologic | 5 mg/kg | Intravenous |
| Subject | Equine COVID-19 Antiserum | Protein / enzyme biologic | 10 mg/kg | Intravenous |