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
Overview
- Phase
- Phase 2
- Intervention
- Standard of Care (SoC)
- Conditions
- SARS-CoV-2 Infection
- Sponsor
- Professor Dr. Bernd Mühlbauer
- Enrollment
- 400
- Locations
- 4
- Primary Endpoint
- Improvement of clinical status on the ordinal 7-point severity-scale at day 15.
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.
Investigators
Professor Dr. Bernd Mühlbauer
Professor of Pharmacology - Head of Department
Klinikum Bremen-Mitte, gGmbH
Eligibility Criteria
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)
Arms & Interventions
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.
Intervention: Standard of Care (SoC)
Remdesivir + SoC
Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care
Intervention: Standard of Care (SoC)
Remdesivir + SoC
Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care
Intervention: Remdesivir
Outcomes
Primary Outcomes
Improvement of clinical status on the ordinal 7-point severity-scale at day 15.
Time Frame: 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 Outcomes
- 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)