Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

Study Overview
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Brief Summary
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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.

Official Title
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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](BSVEQAb) Plus Standard of Care in Comparison to Standard of Care Alone in COVID-19 RT-PCR Positive Patients

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Biological: Equine COVID-19 Antiserum
* Drug: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Equine COVID-19 Antiserum [F(ab')2] (BSVEQAb) Along with Standard of care<br>Dose of BSVEQAb - 5 mg/kg or 10 mg/kg body weight. It is administered as a single dose intravenously after diluting in 100 -150 ml saline. The infusion will be done over 1 to 2 hours. Standard of care for treatment of COVID-19 positive patients | Biological: Equine COVID-19 Antiserum<br>* Equine COVID-19 antiserum is a polyclonal antibody and it contains Equine COVID-19 immune globulin G.<br>* Other names: F(ab)2, BSVEQAb, EqAb-COV-19;Drug: Standard of care<br>* Standard of care for COVID 19 infection based on the current guidelines and institutional practice will be provided<br>|
| Active Comparator: Standard of care.<br>Treatment as per current treatment guidelines and institutional practice for COVID-19 positive patients will be administered | Drug: Standard of care<br>* Standard of care for COVID 19 infection based on the current guidelines and institutional practice will be provided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 Unexpected serious adverse events | 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] | Up to Day 28 | 
| Phase 2 Patients turning COVID-19 negative (RT-PCR negative) | Proportion (percent) of patients turning COVID-19 negative | Day 5 | 
| Phase 2 Patients turning COVID-19 negative (RT-PCR Negative) | Proportion (percent) of patients turning COVID-19 negative | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 Patients turning COVID-19 negative (RT-PCR Negative) | Proportion (percent) of patients patients turning COVID-19 negative | Day 5 | 
| Phase 1 Patients turning COVID-19 negative (RT-PCR Negative) | Proportion (percent) of patients patients turning COVID-19 negative | Day 7 | 
| Phase 1 Exploratory outcome | Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative) | Day 10 | 
| Phase 1 Exploratory outcome | Proportion (percent) of patients turning COVID-19 negative (RT-PCR negative) | Day 14 | 
| Phase 1-Exploratory outcome | Mean reduction in WHO clinical progression scale | Day 3 from Baseline | 
| Phase 1-Exploratory outcome | Mean reduction in WHO clinical progression scale | Day 5 from Baseline | 
| Phase 1- Exploratory outcome | Mean reduction in WHO clinical progression scale | Day 7 from Baseline | 
| Phase 1- Exploratory outcome | Mean reduction in WHO clinical progression scale | Day 14 from Baseline | 
| Phase 1- Exploratory outcome | Mean reduction in WHO clinical progression scale | Day 28 from Baseline | 
| Phase 2 Unexpected serious adverse events | Number of patients with one or more unexpected serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administration | up to Day 28 | 
| Phase 2 Patients turning COVID-19 negative (RT-PCR negative) | Proportion (percent) of patients turning COVID-19 negative | Day 10 | 
| Phase 2 Patients turning COVID-19 negative (RT-PCR negative) | Proportion (percent) of patients turning COVID-19 negative | Day 14 | 
| Phase 2 Change in WHO clinical progression scale | Mean reduction in WHO clinical progression scale | Day 3 from baseline | 
| Phase 2 Change in WHO clinical progression scale | Mean reduction in WHO clinical progression scale | Day 5 from baseline | 
| Phase 2 Change in WHO clinical progression scale | Mean reduction in WHO clinical progression scale | Day 7 from baseline | 
| Phase 2 Change in WHO clinical progression scale | Mean reduction in WHO clinical progression scale | Day 14 from baseline | 
| Phase 2 Change in WHO clinical progression scale | Mean reduction in WHO clinical progression scale | Day 28 from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2019 Novel Coronavirus Disease, COVID19, Coronavirus Disease 2019