An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care - WHO-SOLIDARITY-GERMANY
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Improvement of clinical status on the ordinal 7-point severity-scale at day 15.
研究概览
简要总结
This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years and older
- •Current SARS-CoV-2 infection
- •Admitted to the hospital ward or the ICU due to COVID-19
- •SpO2 <= 94% on room air OR oxygen demand OR breathing support
- •Written informed consent obtained
排除标准
- •Patient's non-consent or inability to informed consent
- •Pregnant or breastfeeding women.
- •Subjects pretreated with one of the study drugs in the past 29 days
- •Anticipated transfer within 72 hours to a non-study hospital
- •Severe co-morbidity with life expectancy < 3 months
- •AST or ALT > 5 times the upper limit of normal
- •Stage 4 severe chronic kidney disease or requiring dialysis
- •Contraindications and known intolerance to any of the study drugs
- •Subjects participating in a potentially confounding drug or device trial
- •Any reason why the patient should not participate (investigator's opinion)
研究组 & 干预措施
Standard of Care (SoC)
This arm will receive standard supportive care according to guidelines for COVID-19. This is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.
干预措施: Standard of Care (SoC) (Other)
Remdesivir + SoC
Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care
干预措施: Standard of Care (SoC) (Other)
Remdesivir + SoC
Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care
干预措施: Remdesivir (Drug)
结局指标
主要结局
Improvement of clinical status on the ordinal 7-point severity-scale at day 15.
时间窗: at day 15
WHO 7-point ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death
次要结局
- Kidney failure(up to 29 days)
- Myocardial failure(up to 29 days)
- Multiple organ failure(up to 29 days)
- Time to an improvement of one category from admission using the 7-point ordinal scale(up to 29 days)
- ECMO: Need of, time to first receiving and duration for extracorporeal membrane oxygenation(up to 29 days)
- Hospital stay: Duration of hospital stay due to COVID-19(up to 29 days)
- Mortality: 28 days mortality; in-house mortality(up to 29 days)
- Oxygen: Need of, time to first receiving and duration of oxygen(up to 29 days)
- Intensive care: Need of, time to first receiving and duration of intensive care(up to 29 days)
- Mechanical ventilation: Need of, time to first receiving and duration of mechanical ventilation(up to 29 days)
- Superinfections, assessed with pathogen testing(up to 29 days)
研究者
Professor Dr. Bernd Mühlbauer
Professor of Pharmacology - Head of Department
Klinikum Bremen-Mitte, gGmbH