A clinical study to evaluate the efficacy of different anti-viral drugs inSARS-CoV-2 infected patients (COVID-19)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 582

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

1.Severe co-morbidity with life expectancy <3 months according to investigators assessment
2.ASAT/ALAT > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>;Primary end point(s): All-cause in-hospital mortality.;Timepoint(s) of evaluation of this end point: During hospitalisation.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): During hospitalisation:<br>- Receipt of mechanical ventilation<br>- Time to first receiving and duration of mechanical ventilation<br>- Receipt of intensive care<br>- Duration of intensive care<br>- Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSARs)<br>- Severe Adverse Events ;Timepoint(s) of evaluation of this end point: Please see above

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