This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.
Other: Standard of Care (SoC)
Standard supportive care is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.
Drug: Remdesivir
Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days or until discharge from hospital, whichever occurs first
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)
Gesundheit Nord gGmbH
Bremen, Germany
Universitätsklinikum Gießen
Gießen, Germany
Medizinische Hochschule Hannover (MHH)
Hannover, Germany
Technische Universität München (TUM)
München, Germany
Tobias Welte, MD, Prof., Principal Investigator
Hannover Medical School