COVID-19, Moderate and Severe COVID-19, SARS-CoV-2 Infection
Conditions
Brief summary
This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.
Interventions
OTHERStandard 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.
DRUGRemdesivir
Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days or until discharge from hospital, whichever occurs first
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
World Health Organization
Professor Dr. Bernd Mühlbauer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of clinical status on the ordinal 7-point severity-scale at day 15. | 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
| Measure | Time frame |
|---|---|
| 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 |
| Time to an improvement of one category from admission using the 7-point ordinal scale | 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 |
| ECMO: Need of, time to first receiving and duration for extracorporeal membrane oxygenation | up to 29 days |
Countries
Germany
Outcome results
None listed