Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Equine COVID-19 Antiserum [F(ab)2] (BSVEQAb)
Along with Standard of care.: Dose of BSVEQAb - 5 mg/kg or 10 mg/kg body weight.
It is administered as a single dose intravenously after di
Sponsors
Bharat Serums and Vaccines ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age Phase 1: >= 18 years to Phase 2: >= 18 years to 2. Are male or non-pregnant females who agree to contraceptive requirements. 3. Patients with RT-PCR confirmed COVID-19 in = 24]. 4. Have SpO2 5. Have one or more of the following- dyspnea, fever, cough, respiratory rate >= 24 per minute and heart rate up to 120 per minute. 6. Patients who agree to participate in the study and follow all study related procedures
Exclusion criteria
Exclusion criteria: 1. Require mechanical ventilation 2. Have oxygen saturation less than or equal to 89 percent 3. Patients re-infected with SARS-CoV-2 4. Suspected or proven serious active bacterial fungal viral or other infection 5.Patients with positive skin test with IP 6. Patients with known equine allergies or past medical history of serum sickness 7. Patient who are HIV, HCV, HbsAg positive or immunocompromised 8. Patients with significant co-morbidities at screening 9. Moribund state 10. Pregnant or nursing women 11. Participating in other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 Number of patients with one or more unexpected serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administration Phase 2 Proportion (percent) of patients turning COVID-19 negative Day 5 and Day 7Timepoint: Phase 1 Baseline through Day 28 Phase 2 Day 5 and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1 Exploratory Outcome Mean reduction in WHO clinical progression scaleTimepoint: Day 3, 5, 7, 14, 28;Phase 1 Exploratory Outcome Proportion (percent) of patients turning COVID-19 negativeTimepoint: day 10 and 14;Phase 1 Proportion (percent) of patients turning COVID-19 negativeTimepoint: Day 5 and Day 7 ;Phase 2 Mean reduction in WHO clinical progression scaleTimepoint: Day 3, 5, 7, 14, 28;Phase 2 Number of patients with one or more unexpected serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administrationTimepoint: Baseline through Day 28;Phase 2 Proportion of patients turning COVID-19 negativeTimepoint: Day 10, 14 | — |
Countries
India
Contacts
Public ContactAnirban Roy Chowdhury
Bharat serums and Vaccines LTd
Outcome results
None listed