The Efficacy of Different Anti-viral Drugs in COVID 19 Infected Patients

• Status: Recruiting
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The (World Health Organization) WHO NOR- (Coronavirus infectious disease) COVID 19 study is a multi-centre, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized adult patients diagnosed with COVID-19. This trial will follow the core WHO protocol but has additional efficacy, safety and explorative endpoints.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Antiviral Agents; Hydroxychloroquine; Remdesivir

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

Exclusion Criteria:

1. Severe co-morbidity with life expectancy <3 months according to investigators assessment

2. (Aspartate Transaminase/ Alanine Aminotransferase) 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, possible 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 (>450 ms)