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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

Primary Purpose

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

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Standard of Care (SoC)
Remdesivir
Sponsored by
Professor Dr. Bernd Mühlbauer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV-2 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Gesundheit Nord gGmbH
  • Universitätsklinikum Gießen
  • Medizinische Hochschule Hannover (MHH)
  • Technische Universität München (TUM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard of Care (SoC)

Remdesivir + SoC

Arm Description

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.

Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2020
Last Updated
October 2, 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
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1. Study Identification

Unique Protocol Identification Number
NCT04575064
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the 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

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection, COVID-19, Moderate and Severe COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care (SoC)
Arm Type
Other
Arm Description
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.
Arm Title
Remdesivir + SoC
Arm Type
Experimental
Arm Description
Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care
Intervention Type
Other
Intervention Name(s)
Standard of Care (SoC)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Remdesivir
Intervention Description
Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days or until discharge from hospital, whichever occurs first
Primary Outcome Measure Information:
Title
Improvement of clinical status on the ordinal 7-point severity-scale at day 15.
Description
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
Time Frame
at day 15
Secondary Outcome Measure Information:
Title
Time to an improvement of one category from admission using the 7-point ordinal scale
Time Frame
up to 29 days
Title
Mortality: 28 days mortality; in-house mortality
Time Frame
up to 29 days
Title
Hospital stay: Duration of hospital stay due to COVID-19
Time Frame
up to 29 days
Title
Oxygen: Need of, time to first receiving and duration of oxygen
Time Frame
up to 29 days
Title
Intensive care: Need of, time to first receiving and duration of intensive care
Time Frame
up to 29 days
Title
Mechanical ventilation: Need of, time to first receiving and duration of mechanical ventilation
Time Frame
up to 29 days
Title
ECMO: Need of, time to first receiving and duration for extracorporeal membrane oxygenation
Time Frame
up to 29 days
Title
Superinfections, assessed with pathogen testing
Time Frame
up to 29 days
Title
Kidney failure
Time Frame
up to 29 days
Title
Myocardial failure
Time Frame
up to 29 days
Title
Multiple organ failure
Time Frame
up to 29 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Welte, MD, Prof.
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gesundheit Nord gGmbH
City
Bremen
ZIP/Postal Code
28211
Country
Germany
Facility Name
Universitätsklinikum Gießen
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Medizinische Hochschule Hannover (MHH)
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Technische Universität München (TUM)
City
München
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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