SARS-CoV-2 Infection
Conditions
Keywords
2019 Novel Coronavirus Disease, COVID19, Coronavirus Disease 2019
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 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.
Interventions
BIOLOGICALEquine COVID-19 Antiserum
Equine COVID-19 antiserum is a polyclonal antibody and it contains Equine COVID-19 immune globulin G.
DRUGStandard of care
Standard of care for COVID 19 infection based on the current guidelines and institutional practice will be provided
Sponsors
Bharat Serums and Vaccines Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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. Each patient will receive either of the dose BSVEQAb - 5 mg/kg or 10 mg/kg body weight and all will receive standard of care Based on the results of phase 1 study the phase 2 shall be initiated. In phase 2 study one group will receive the tolerable dose of BSVEQAb selected along with standard of care. The second group will receive only standard of care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age Phase 1: ≥ 18 years to ≤ 55 years Phase 2: ≥ 18 years to ≤ 65 years 2. Are male or non-pregnant females who agree to contraceptive requirements. 3. Patients with RT-PCR confirmed COVID-19 in ≤ 72 hours prior to randomization \[Ct ≥ 24\]. 4. Have SpO2\<94% (range 90-93%) on room air. 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
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 | Description |
|---|---|---|
| Phase 1 Unexpected serious adverse events | Up to Day 28 | Number of patients with one or more unexpected serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administration \[Baseline through Day 28\] |
| Phase 2 Patients turning COVID-19 negative (RT-PCR negative) | Day 5 | Proportion (percent) of patients turning COVID-19 negative |
| Phase 2 Patients turning COVID-19 negative (RT-PCR Negative) | Day 7 | Proportion (percent) of patients turning COVID-19 negative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1- Exploratory outcome | Day 7 from Baseline | Mean reduction in WHO clinical progression scale |
| Phase 2 Unexpected serious adverse events | up to Day 28 | 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 1 Patients turning COVID-19 negative (RT-PCR Negative) | Day 5 | Proportion (percent) of patients patients turning COVID-19 negative |
| Phase 2 Change in WHO clinical progression scale | Day 3 from baseline | Mean reduction in WHO clinical progression scale |
| Phase 2 Patients turning COVID-19 negative (RT-PCR negative) | Day 10 | Proportion (percent) of patients turning COVID-19 negative |
| Phase 1 Exploratory outcome | Day 10 | Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative) |
| Phase 1-Exploratory outcome | Day 3 from Baseline | Mean reduction in WHO clinical progression scale |
Countries
India
Outcome results
None listed