SARS-COV-2 infection MedDRA version: 21.1 Level: LLT Classification code 10037373 Term: Pulmonary disorder System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Veklury
Product Name: Remdesivir
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: REMDESIVIR
Other descriptive name: Remdesivir
Concentration unit: mg milli
Sponsors
University of Helsinki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients, 18 years and above 2. Confirmed SARS-2-CoV-2 infection by PCR 3. Admitted to the hospital ward or the ICU 4. Subjects (or legally authorized representative) provides written informed consent prior to initiation of the study 5. No anticipated transfer within 72 hours to a non-study hospital 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 291 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 291
Exclusion criteria
Exclusion criteria: 1.Severe co-morbidity with life expectancy 5 times the upper limit of normal 3.Acute co-morbidity within 7 days before inclusion such as myocardial infarction or UAP (not including troponin elevation due to infection) 4.Known intolerance to the available study drugs 5.Pregnancy or breast feeding 6.Any reason why, in the opinion of the investigators, the patient should not participate 7.Subject participates in a potentially confounding drug or device trial during the course of the study 8.Already receiving any of the study drugs 9.Renal failure (eGRF < 30 mL/min) or dialysis or continuous veno-venous hemofiltration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of Remdesivir on all-cause in-hospital mortality compared to standard of care.;Secondary Objective: - To assess the effect of Remdesivir treatment on hospital duration, receipt of ventilation or intensive care, and to identify any serious adverse reactions. ;Primary end point(s): All-cause in-hospital mortality.;Timepoint(s) of evaluation of this end point: During hospitalisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): During hospitalisation: - Receipt of mechanical ventilation - Time to first receiving and duration of mechanical ventilation - Receipt of intensive care - Duration of intensive care - Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSARs) - Severe Adverse Events ;Timepoint(s) of evaluation of this end point: Please see above | — |
Countries
Finland
Contacts
Public ContactDept. of Public Health
University of Helsinki
Outcome results
None listed