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Withdrawn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- WITHDRAWN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 Time to an improvement of one category from admission using the 7-point ordinal scale up to 29 days Hospital stay: Duration of hospital stay due to COVID-19 up to 29 days Kidney failure up to 29 days Multiple organ failure up to 29 days Myocardial failure 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
Trial Locations
- Locations (4)
Universitätsklinikum Gießen
🇩🇪Gießen, Germany
Medizinische Hochschule Hannover (MHH)
🇩🇪Hannover, Germany
Gesundheit Nord gGmbH
🇩🇪Bremen, Germany
Technische Universität München (TUM)
🇩🇪München, Germany