Efficacy and Safety of Treatment With Convalescent Plasma for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multicenter Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 147
- 试验地点
- 12
- 主要终点
- All-cause mortality or need of invasive mechanical ventilation
研究概览
简要总结
CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19.
Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo.
Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.
详细描述
The study is a randomized, double blinded, placebo-controlled, multicenter study with two parallel treatment arms consisting of either convalescent plasma or intravenous placebo. We plan to enroll a total of 1100 patients yielding a statistical power of 80 % to show a 30% relative reduction in risk of mechanical ventilation or death at day 28. Patients with confirmed COVID-19 infection and signs compatible with pneumonia will be enrolled in the study. The participants will be randomized 2:1 to the parallel treatment arms, and receive either single dose infusion treatment.
The primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days. Interim analysis will be performed frequently.
As new knowledge of treatment options for COVID-19 have emerged, the treatment arms including sarilumab, baricitininb, hydroxychloroquine and oral placebo have been terminated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both convalescent plasma and placebo will be administered via a colored intravenous line with a colored sleeve disguising the fluid bag.
In order to achieve blinding of participants and treating personnel, patients randomized to active treatment will also receive placebo treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Confirmed COVID-19 infection by presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR)
- •Evidence of pneumonia given by at least one of the following: SpO2 ≤93% on ambient air or PaO2/FiO2 <300 mmHg/40 kPa OR Radiographic findings compatible with COVID-19 pneumonia
- •For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period
- •Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives
排除标准
- •In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
- •Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by sponsor)*
- •Pregnant or breastfeeding, positive pregnancy test in a pre-dose examination
- •Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
结局指标
主要结局
All-cause mortality or need of invasive mechanical ventilation
时间窗: 28 days
Composite outcome
次要结局
- Duration of supplemental oxygen(90 days)
- Length of hospital stay(90 days)
- Frequency of adverse events(90 days)
- Frequency of severe adverse events(90 days)
- Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status(90 days)
- Ventilator-free days(28 days)
- Organ failure-free days(28 days)
- Duration of ICU stay(90 days)
- Mortality rate(7, 14, 21, 28 and 90 days)
研究者
Thomas Benfield
Professor
Hvidovre University Hospital