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

Sponsor

Professor Dr. Bernd Mühlbauer (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04575064

Collaborator

Dept. of Statistics and Medical Biometry, University of Bremen (Other), INSERM (Institut national de la santé et de la recherche médicale), Paris, France (Other), World Health Organization (WHO), R&D Blueprint, Geneva, Switzerland (Other)

400

Enrollment

Locations

Arms

28.1

Anticipated Duration (Months)

100

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Jun 29, 2020

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Improvement of clinical status on the ordinal 7-point severity-scale at day 15. [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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Gesundheit Nord gGmbH	Bremen	Germany	28211
2	Universitätsklinikum Gießen	Gießen	Germany	35392
3	Medizinische Hochschule Hannover (MHH)	Hannover	Germany	30625
4	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

First Posted:

Oct 5, 2020

Last Update Posted:

Oct 5, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Remdesivir

Study Results

No Results Posted as of Oct 5, 2020