Official Title
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
Brief Summary

This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.

Unknown status
SARS-CoV-2 Infection
COVID-19
Moderate and Severe COVID-19

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

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Locations

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

Professor Dr. Bernd Mühlbauer
NCT Number
MeSH Terms
COVID-19
Remdesivir