This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days or until discharge from hospital, whichever occurs first
Gesundheit Nord gGmbH
Bremen, Germany
Universitätsklinikum Gießen
Giessen, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, Germany
Technische Universität München (TUM)
München, Germany
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
Time frame: at day 15
Time to an improvement of one category from admission using the 7-point ordinal scale
Time frame: up to 29 days
Mortality: 28 days mortality; in-house mortality
Time frame: up to 29 days
Hospital stay: Duration of hospital stay due to COVID-19
Time frame: up to 29 days
Oxygen: Need of, time to first receiving and duration of oxygen
Time frame: up to 29 days
Intensive care: Need of, time to first receiving and duration of intensive care
Time frame: up to 29 days
Mechanical ventilation: Need of, time to first receiving and duration of mechanical ventilation
Time frame: up to 29 days
ECMO: Need of, time to first receiving and duration for extracorporeal membrane oxygenation
Time frame: up to 29 days
Superinfections, assessed with pathogen testing
Time frame: up to 29 days
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Kidney failure
Time frame: up to 29 days
Myocardial failure
Time frame: up to 29 days
Multiple organ failure
Time frame: up to 29 days