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

• ClinicalTrials.gov Identifier: NCT04575064
• Recruitment Status: Active, not recruiting
• First Posted: October 5, 2020
• Last Update Posted: October 5, 2020
• 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
• Information provided by (Responsible Party): Professor Dr. Bernd Mühlbauer, Klinikum Bremen-Mitte, gGmbH

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
SARS-CoV-2 Infection; COVID-19; Moderate and Severe COVID-19	Other: Standard of Care (SoC); Drug: Remdesivir	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 29, 2020
• Estimated Primary Completion Date: March 2022
• Estimated Study Completion Date: November 2022

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Improvement of clinical status on the ordinal 7-point severity-scale at day 15. [ Time Frame: at day 15 ]

   WHO 7-point ordinal scale:

   1. Not hospitalized, no limitations on activities;
   2. Not hospitalized, limitation on activities;
   3. Hospitalized, not requiring supplemental oxygen;
   4. Hospitalized, requiring supplemental oxygen;
   5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
   6. Hospitalized, on invasive mechanical ventilation or ECMO;
   7. Death

Secondary Outcome Measures :

1. Time to an improvement of one category from admission using the 7-point ordinal scale [ Time Frame: up to 29 days ]
2. Mortality: 28 days mortality; in-house mortality [ Time Frame: up to 29 days ]
3. Hospital stay: Duration of hospital stay due to COVID-19 [ Time Frame: up to 29 days ]
4. Oxygen: Need of, time to first receiving and duration of oxygen [ Time Frame: up to 29 days ]
5. Intensive care: Need of, time to first receiving and duration of intensive care [ Time Frame: up to 29 days ]
6. Mechanical ventilation: Need of, time to first receiving and duration of mechanical ventilation [ Time Frame: up to 29 days ]
7. ECMO: Need of, time to first receiving and duration for extracorporeal membrane oxygenation [ Time Frame: up to 29 days ]
8. Superinfections, assessed with pathogen testing [ Time Frame: up to 29 days ]
9. Kidney failure [ Time Frame: up to 29 days ]
10. Myocardial failure [ Time Frame: up to 29 days ]
11. Multiple organ failure [ Time Frame: up to 29 days ]

Eligibility Criteria

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

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)

Contacts and Locations

Locations

Germany

Gesundheit Nord gGmbH

Bremen, Germany, 28211

Universitätsklinikum Gießen

Gießen, Germany, 35392

Medizinische Hochschule Hannover (MHH)

Hannover, Germany, 30625

Technische Universität München (TUM)

München, Germany, 81675

Sponsors and Collaborators

Professor Dr. Bernd Mühlbauer

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

Investigators

• Principal Investigator: Tobias Welte, MD, Prof.; Hannover Medical School

More Information

• Responsible Party: Professor Dr. Bernd Mühlbauer, Professor of Pharmacology - Head of Department, Klinikum Bremen-Mitte, gGmbH
• ClinicalTrials.gov Identifier: NCT04575064
• Other Study ID Numbers: WHO-SOLIDARITY-GERMANY; 2020-001549-38 ( EudraCT Number )
• First Posted: October 5, 2020
• Last Update Posted: October 5, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Remdesivir; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents