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

Professor Dr. Bernd Mühlbauer

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: COVID-19; SARS-CoV-2 Infection; Moderate and Severe COVID-19

Treatments: Drug: Remdesivir; Other: Standard of Care (SoC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04575064

WHO-SOLIDARITY-GERMANY

2020-001549-38 (EudraCT Number)

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard of Care (SoC)

Other group

Description:

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.

Treatment:

Other: Standard of Care (SoC)

Remdesivir + SoC

Experimental group

Description:

Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care

Treatment:

Other: Standard of Care (SoC)

Drug: Remdesivir