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
Phase 2
Withdrawn
- Conditions
- Moderate and Severe COVID-19SARS-CoV-2 InfectionCOVID-19
- Interventions
- Other: Standard of Care (SoC)
- Registration Number
- NCT04575064
- Lead Sponsor
- Professor Dr. Bernd Mühlbauer
- Brief Summary
This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care (SoC) 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. Remdesivir + SoC Standard of Care (SoC) Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care Remdesivir + SoC Remdesivir Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care
- Primary Outcome Measures
Name Time Method Improvement of clinical status on the ordinal 7-point severity-scale at day 15. 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
- Secondary Outcome Measures
Name Time Method 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 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 Hospital stay: Duration of hospital stay due to COVID-19 up to 29 days
Trial Locations
- Locations (4)
Gesundheit Nord gGmbH
🇩🇪Bremen, Germany
Universitätsklinikum Gießen
🇩🇪Gießen, Germany
Medizinische Hochschule Hannover (MHH)
🇩🇪Hannover, Germany
Technische Universität München (TUM)
🇩🇪München, Germany
Gesundheit Nord gGmbH🇩🇪Bremen, Germany