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.
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.
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)
Andreas Barratt-Due
Oslo, Norway
Investigator: ANDREAS BARRATT-DUE, PhD
Contact: +47 98209974
andreas.barrattdue@gmail.com
Paul Aukrust, MD, Professor
0047 46778374
paukrust@ous-hf.no
Andreas Barratt-Due, MD, PhD
0047 98209974
andreas.barrattdue@gmail.com