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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04575064
Recruitment Status : Active, not recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
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

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

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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

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04575064


Locations
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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
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Principal Investigator: Tobias Welte, MD, Prof. Hannover Medical School
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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    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020

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