COVID-19 MedDRA version: 21.1 Level: LLT Classification code 10037373 Term: Pulmonary disorder System Organ Class: 100000004855
Conditions
Interventions
Product Name: Remdesivir
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: REMDESIVIR
Current Sponsor code: remdesivir
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Gesundheit Nord gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients 18 years and older • SARS-CoV-2 infection confirmed by PCR in any specimen =65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: • 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: Not applicable;Primary end point(s): improvement of the clinical status on the ordinal 7-point severity-scale at day 15: 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;Timepoint(s) of evaluation of this end point: day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to an improvement of one category from admission using the 7-point ordinal scale • Mortality: in-house mortality; 28 days mortality; 90 days 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 extracorporal membrane oxygenation • Superinfections • Kidney failure • Myocardial failure • Multiple organ failure;Timepoint(s) of evaluation of this end point: • day 28 • end of hospital stay • time to receiving intensive care • time to receiving mechanical ventilation • day 90 | — |
Countries
Germany
Contacts
Public ContactInstitut für Pharmakologie
Gesundheit Nord gGmbH
Outcome results
None listed