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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Phase 1 Unexpected serious adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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 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
干预措施: Equine COVID-19 Antiserum (Biological)
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 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
干预措施: Standard of care (Drug)
Standard of care.
Treatment as per current treatment guidelines and institutional practice for COVID-19 positive patients will be administered
干预措施: Standard of care (Drug)
结局指标
主要结局
Phase 1 Unexpected serious adverse events
时间窗: 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)
时间窗: Day 5
Proportion (percent) of patients turning COVID-19 negative
Phase 2 Patients turning COVID-19 negative (RT-PCR Negative)
时间窗: Day 7
Proportion (percent) of patients turning COVID-19 negative
次要结局
- Phase 2 Patients turning COVID-19 negative (RT-PCR negative)(Day 14)
- Phase 1-Exploratory outcome(Day 5 from Baseline)
- Phase 1 Exploratory outcome(Day 14)
- Phase 1 Patients turning COVID-19 negative (RT-PCR Negative)(Day 7)
- Phase 1- Exploratory outcome(Day 28 from Baseline)
- Phase 2 Unexpected serious adverse events(up to Day 28)
- Phase 2 Change in WHO clinical progression scale(Day 28 from baseline)