NCT04573855Unknown1 期
TREATMENT WITH ANTI-SARS-COV-2 IMMUNOGLOBULIN IN PATIENTS WITH COVID-19: A PHASE I / II STUDY
D'Or Institute for Research and Education0 个研究点目标入组 41 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 41
- 主要终点
- Clearence of viral RNA evaluated by RT-PCR
研究概览
简要总结
A Phase I/II clinical trial for safety and efficacy evaluation of treatment with anti-SARS-CoV-2 equine immunoglobulin (F(ab')2) in hospitalized patients with COVID-19 not requiring of invasive ventilation support.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients diagnosed with COVID-19 by RT-PCR;
- •Time between symptom onset and inclusion ≤ 10 days;
- •Age ≥ 18 years and <75 years
- •No indication of invasive ventilatory support at the time of randomization;
- •Signature of the Informed Consent Form.
排除标准
- •Pregnant or lactating women
- •Severe comorbidity: Severe heart disease, severe COPD or O2-dependent COPD, terminal cancer.
- •Any confirmed or suspected immunosuppressive or immunodeficiency state, including HIV (regardless of treatment, CD4 count or viral load status); asplenia; severe recurrent infections and chronic use (more than 14 days) of immunosuppressive medication in the last 6 months, except for topical steroids or short-term oral steroids (cycle lasting ≤14 days);
- •History of anaphylaxis or severe allergic reaction;
- •Previous use of any heterologous serum;
- •Participation in trials of prophylactic drugs or vaccines for COVID-19;
- •Administration of immunoglobulins and / or any blood products in the previous three months.
研究组 & 干预措施
Control
No Intervention
Anti-SARS-CoV-2 immunoglobulin
Experimental
Treatment with Anti-SARS-CoV-2 immunoglobulin
干预措施: Anti-SARS-CoV-2 immunoglobulin (Biological)
结局指标
主要结局
Clearence of viral RNA evaluated by RT-PCR
时间窗: 72 h
Rate of adverse events related to the infusion of anti-SARS-CoV-2 immunoglobulin through CTCAE v4.0.
时间窗: 28 days
次要结局
- Infusional reaction rate(28 days)
- Evaluation of clinical status(Day 0, Day 14, Day 21 and Day 28)
- Length of hospital stay(For as long as the duration of the hospital stay)
- Orotracheal Intubation Rate(28 days)
- Mortality rate(28 days)
- Modulation of serum and cellular inflammatory marker(Day 0, Day 3 and Day 7.)
- Reduction of viral load evaluated by area under the curve of RT-PCR values(Day 0, Day 3, Day 7 and Day 14)
- Assessment of adverse events(28 days)
研究者
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