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

Phase 1

• Conditions: SARS-COV-2 infection; MedDRA version: 21.1Level: LLTClassification code 10037373Term: Pulmonary disorderSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-000982-18-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-24
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 443

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 221
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 222

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
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.Prolonged QT interval (>470 ms)

9.Already receiving any of the study drugs
10. Hydroxychloroquine should not be given to patients with psoriasis.

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 and Hydroxychloroquine on all-cause in-hospital mortality in moderate and in severe COVID 19.<br><br>;Secondary Objective: - To assess the effect of Remdesivir and Hydroxychloroquine treatment on hospital duration, receipt of ventilation or intensive care, and to identify any serious adverse reactions.<br>- To assess the effect of Remdesivir and Hydroxychloroquine treatment on 28 days mortality, viral clearance, kidney and myocardial failure, co-infections, organ dysfunction, health-related Quality of Life and biomarkers.<br>- To assess safety of Remdesivir and Hydroxychloroquine on severe, life-threatening and/or serious adverse events;Primary end point(s): All-cause in-hospital mortality. ;Timepoint(s) of evaluation of this end point: During hospitalisation.