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
- Conditions
- COVID-19MedDRA version: 21.1Level: LLTClassification code 10037373Term: Pulmonary disorderSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-001549-38-DE
- Lead Sponsor
- Gesundheit Nord gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
•Patients 18 years and older
•SARS-CoV-2 infection confirmed by PCR in any specimen < 9 days prior to randomization
•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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
•Patient's non-consent or inability to informed consent
•Pregnant or breastfeeding women
•Subjects pretreated with one of the active 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 according to investigators opinion
•AST or ALT > 5 times the upper limit of normal
•Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min)
•Contraindications to any of the active study drugs
•Subjects participating in a potentially confounding drug or device trial during the course of the study in the last 29 days
•Any reason why, in the opinion of the investigators, the patient should not participate
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The overall objective of the study is to evaluate the clinical efficacy and safety of investigational therapeutics relative to the control arm among hospitalized adult patients who have COVID-19.<br>;Secondary Objective: Not applicable;Primary end point(s): improvement of the clinical status on the ordinal 7-point severity-scale at day 15:<br>1. Not hospitalized, no limitations on activities;<br>2. Not hospitalized, limitation on activities;<br>3. Hospitalized, not requiring supplemental oxygen;<br>4. Hospitalized, requiring supplemental oxygen;<br>5. Hospitalized, on non-invasive ventilation or high flow oxygen<br>devices;<br>6. Hospitalized, on invasive mechanical ventilation or ECMO;<br>7. Death;Timepoint(s) of evaluation of this end point: day 15
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Time to an improvement of one category from admission using the 7-point ordinal scale <br>•Mortality: in-house mortality; 28 days mortality; 90 days mortality<br>•Hospital stay: Duration of hospital stay due to COVID-19<br>•Oxygen: Need of, time to first receiving and duration of oxygen<br>•Intensive care: Need of, time to first receiving and duration of intensive care <br>•Mechanical ventilation: Need of, time to first receiving and duration of mechanical ventilation <br>•ECMO: Need of, time to first receiving and duration for extracorporal membrane oxygenation <br>•Superinfections <br>•Kidney failure<br>•Myocardial failure<br>•Multiple organ failure;Timepoint(s) of evaluation of this end point: •day 28<br>•end of hospital stay<br>•time to receiving intensive care <br>•time to receiving mechanical ventilation <br>•day 90