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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04575064
• Other study ID #: WHO-SOLIDARITY-GERMANY
• Secondary ID: 2020-001549-38
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: June 29, 2020
• Est. completion date: November 2022

Study information

• Verified date: October 2020
• Source: Klinikum Bremen-Mitte, gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: November 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Germany	Gesundheit Nord gGmbH	Bremen
Germany	Universitätsklinikum Gießen	Gießen
Germany	Medizinische Hochschule Hannover (MHH)	Hannover
Germany	Technische Universität München (TUM)	München

Sponsors (4)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to an improvement of one category from admission using the 7-point ordinal scale		up to 29 days
Secondary	Mortality: 28 days mortality; in-house mortality		up to 29 days
Secondary	Hospital stay: Duration of hospital stay due to COVID-19		up to 29 days
Secondary	Oxygen: Need of, time to first receiving and duration of oxygen		up to 29 days
Secondary	Intensive care: Need of, time to first receiving and duration of intensive care		up to 29 days
Secondary	Mechanical ventilation: Need of, time to first receiving and duration of mechanical ventilation		up to 29 days
Secondary	ECMO: Need of, time to first receiving and duration for extracorporeal membrane oxygenation		up to 29 days
Secondary	Superinfections, assessed with pathogen testing		up to 29 days
Secondary	Kidney failure		up to 29 days
Secondary	Myocardial failure		up to 29 days
Secondary	Multiple organ failure		up to 29 days