Clinical trial NCT04834908: Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: SARS-CoV-2 Infection
Keywords: 2019 Novel Coronavirus Disease
COVID19
Coronavirus Disease 2019
Lead sponsor: Bharat Serums and Vaccines Limited
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Phase 1 Unexpected serious adverse events
timeFrame: Up to Day 28
measure: Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
timeFrame: Day 5
measure: Phase 2 Patients turning COVID-19 negative (RT-PCR Negative)
timeFrame: Day 7
Secondary outcomes:
measure: Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)
timeFrame: Day 5
measure: Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)
timeFrame: Day 7
measure: Phase 1 Exploratory outcome
timeFrame: Day 10
measure: Phase 1 Exploratory outcome
timeFrame: Day 14
measure: Phase 1-Exploratory outcome
timeFrame: Day 3 from Baseline
measure: Phase 1-Exploratory outcome
timeFrame: Day 5 from Baseline
measure: Phase 1- Exploratory outcome
timeFrame: Day 7 from Baseline
measure: Phase 1- Exploratory outcome
timeFrame: Day 14 from Baseline
measure: Phase 1- Exploratory outcome
timeFrame: Day 28 from Baseline
measure: Phase 2 Unexpected serious adverse events
timeFrame: up to Day 28
measure: Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
timeFrame: Day 10
measure: Phase 2 Patients turning COVID-19 negative (RT-PCR negative)
timeFrame: Day 14
measure: Phase 2 Change in WHO clinical progression scale
timeFrame: Day 3 from baseline
measure: Phase 2 Change in WHO clinical progression scale
timeFrame: Day 5 from baseline
measure: Phase 2 Change in WHO clinical progression scale
timeFrame: Day 7 from baseline
measure: Phase 2 Change in WHO clinical progression scale
timeFrame: Day 14 from baseline
measure: Phase 2 Change in WHO clinical progression scale
timeFrame: Day 28 from baseline
Other outcomes:
Locations:
city: Pune
country: India
facility: Jehangir Hospital
state: Maharashtra
Study officials:
affiliation: Bharat Serums and Vaccines Ltd
name: Ramesh Jagannathan
role: PRINCIPAL_INVESTIGATOR
References: