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

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

Study Overview

• Status: Withdrawn
• Conditions: COVID-19; SARS-CoV-2 Infection; Moderate and Severe COVID-19
• Intervention / Treatment: Other: Standard of Care (SoC); Drug: Remdesivir

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Bremen, Germany, 28211
    • Gesundheit Nord gGmbH
  • Gießen, Germany, 35392
    • Universitätsklinikum Giessen
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover (MHH)
  • München, Germany, 81675
    • Technische Universität München (TUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.
Experimental: Remdesivir + SoC; Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of clinical status on the ordinal 7-point severity-scale at day 15.	WHO 7-point ordinal scale: Not hospitalized, no limitations on activities;; Not hospitalized, limitation on activities;; Hospitalized, not requiring supplemental oxygen;; Hospitalized, requiring supplemental oxygen;; Hospitalized, on non-invasive ventilation or high flow oxygen devices;; Hospitalized, on invasive mechanical ventilation or ECMO;; Death	at day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to an improvement of one category from admission using the 7-point ordinal scale	up to 29 days
Mortality: 28 days mortality; in-house mortality	up to 29 days
Hospital stay: Duration of hospital stay due to COVID-19	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
ECMO: Need of, time to first receiving and duration for extracorporeal membrane oxygenation	up to 29 days
Superinfections, assessed with pathogen testing	up to 29 days
Kidney failure	up to 29 days
Myocardial failure	up to 29 days
Multiple organ failure	up to 29 days

Collaborators and Investigators

• Sponsor: Professor Dr. Bernd Mühlbauer
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; World Health Organization
• Investigators: Principal Investigator: Tobias Welte, MD, Prof., Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Estimated): March 1, 2022
• Study Completion (Estimated): November 1, 2022

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Remdesivir
• Other Study ID Numbers: WHO-SOLIDARITY-GERMANY; 2020-001549-38 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No