CONTAIN COVID-19: Convalescent Plasma to Limit Coronavirus Associated Complications: a Randomized Blinded Phase 2 Study Comparing the Efficacy and Safety of Anti-SARS-CoV2 Plasma to Placebo in COVID-19 Hospitalized Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 941
- 试验地点
- 9
- 主要终点
- Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 14 Days
研究概览
简要总结
This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation.
详细描述
A total of 300 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent plasma (CP) from people who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or a placebo control, Lactated Ringer's Solution (LR) or saline solution (SS). Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the onset of illness OR within 3 days of hospitalization will be eligible to participate.
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
- Double (Participant, Investigator)
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
- •Patients ≥18 years of age
- •Hospitalized with laboratory confirmed COVID-19
- •One or more of the following respiratory signs or symptoms: cough, chest pain, shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)
- •Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness
- •On supplemental oxygen, non-invasive ventilation or high-flow oxygen
- •Patients may be on other randomized controlled trials of pharmaceuticals for COVID -19 and patients who meet eligibility criteria will not be excluded on this basis.
排除标准
- •Receipt of pooled immunoglobulin in past 30 days
- •Contraindication to transfusion or history of prior reactions to transfusion blood products
- •Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- •Volume overload secondary to congestive heart failure or renal failure
- •Unlikely to survive past 72 hours from screening based on the assessment of the investigator
- •Unlikely to be able to assess and follow outcome due to poor functional status
研究组 & 干预措施
Lactated ringer's solution or sterile saline solution
干预措施: Saline solution (Other)
Convalescent donor plasma
干预措施: Convalescent Plasma (Biological)
结局指标
主要结局
Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 14 Days
时间窗: 14 days post-randomization
Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation \& Mechanical ventilation; pO2/FIO2 \>/= 150 or SpO2/FIO2 \>/=200 8 Mechanical ventilation pO2/FIO2 \< 150 (SpO2/FIO2 \<200) or vasopressors 9 Mechanical ventilation pO2/FIO2 \< 150 and vasopressors, dialysis or ECMO Death 10 Dead
次要结局
- Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 28 Days(28 days post-randomization)