Status:
TERMINATED
Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection
Lead Sponsor:
Bharat Serums and Vaccines Limited
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Age Phase 1: ≥ 18 years to ≤ 55 years Phase 2: ≥ 18 years to ≤ 65 years
- Are male or non-pregnant females who agree to contraceptive requirements.
- Patients with RT-PCR confirmed COVID-19 in ≤ 72 hours prior to randomization \[Ct ≥ 24\].
- Have SpO2\<94% (range 90-93%) on room air.
- Have one or more of the following- dyspnea, fever, cough, respiratory rate ≥ 24 per minute and heart rate up to 120 per minute.
- Patients who agree to participate in the study and follow all study related procedures
Exclusion
- Require mechanical ventilation
- Have oxygen saturation less than or equal to 89 percent
- Patients re-infected with SARS-CoV-2
- Suspected or proven serious active bacterial fungal viral or other infection
- Patients with positive skin test with IP
- Patients with known equine allergies or past medical history of serum sickness
- Patient who are HIV, HCV, HbsAg positive or immunocompromised
- Patients with significant co-morbidities at screening
- Moribund state
- Pregnant or nursing women
- Participating in other clinical trial
Key Trial Info
Start Date :
July 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04834908
Start Date
July 27 2021
End Date
May 25 2022
Last Update
October 14 2022
Active Locations (1)
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1
Jehangir Hospital
Pune, Maharashtra, India, 411001