The Efficacy of Different Anti-viral Drugs in COVID 19 Infected Patients
NCT04321616 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 700
Last updated 2020-04-14
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.
Conditions
- SARS-CoV Infection
- COVID 19
- Acute Respiratory Distress Syndrome ARDS
Interventions
- DRUG
-
Hydroxychloroquine
Hydroxychloroquine will be given orally (in the ICU in gastrointestinal tubes) with 800 mg x 2 loading dose followed by 400 mg x 2 every day for a total of 10 days.
- DRUG
-
Remdesivir
Remdesivir will be given intravenously 100 mg daily for the duration of the hospitalization and up to 10 days total course. A loading dose of 200 mg at inclusion will be given.
- OTHER
-
(Standard of Care) SoC
The standard of care will be supplied to all patients not receiving a drug intervention.
Sponsors & Collaborators
-
Oslo University Hospital
lead OTHER
Principal Investigators
-
Paul Aukrust, MD, Professor · Oslo University Hospital
-
Andreas Barratt-Due, MD, PhD · Oslo University Hospital
-
Trine Kåsine, MD · Oslo University Hospital
-
Katerina Nezvalova-Henriksen, Pharm D, PhD · Oslo Hospital Pharmacies
-
Anne Margarita Dyrhol Riise, MD, Professor · Oslo University Hospital
-
Marius Trøseid, MD, PhD · Oslo University Hospital
-
Inge Christoffer Olsen, PhD · NorCRIN
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-28
- Primary Completion
- 2020-08-31
- Completion
- 2020-11-30
Countries
- Norway
Study Locations
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