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

NCT04575064 | Withdrawn Phase 2

• 2 other identifiers: WHO-SOLIDARITY-GERMANY2020-001549-38
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Improvement of clinical status on the ordinal 7-point severity-scale 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

  at day 15

Secondary Outcomes (11)

• 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

Study Arms (2)

Standard of Care (SoC)

OTHER

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)

Remdesivir + SoC

EXPERIMENTAL

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); Drug: Remdesivir

Interventions

Standard of Care (SoC) OTHER

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.

Remdesivir + SoC; Standard of Care (SoC)

Remdesivir DRUG

Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days or until discharge from hospital, whichever occurs first

Remdesivir + SoC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Professor Dr. Bernd Mühlbauer: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• World Health Organization: collaborator

Study Sites (4)

Gesundheit Nord gGmbH

Bremen, 28211, Germany

Location

Universitätsklinikum Gießen

Giessen, 35392, Germany

Location

Medizinische Hochschule Hannover (MHH)

Hanover, 30625, Germany

Location

Technische Universität München (TUM)

München, 81675, Germany

Location

MeSH Terms

Conditions

COVID-19; Lymphoma, Follicular

Interventions

Standard of Care; remdesivir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tobias Welte, MD, Prof.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pharmacology - Head of Department

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 5, 2020
• Study Start: June 29, 2020
• Primary Completion: March 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

DE (4)