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

• Status: Active, not recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Professor Dr. Bernd Mühlbauer
• Collaborators: Dept. of Statistics and Medical Biometry, University of Bremen; INSERM (Institut national de la santé et de la recherche médicale), Paris, France; World Health Organization (WHO), R&D Blueprint, Geneva, Switzerland
• Treatments: Remdesivir

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)