Acute Respiratory Distress Syndrome ARDS, COVID 19, SARS-CoV Infection
Conditions
Keywords
Effect of drugs, Adverse effects of drugs, SARS-CoV clearance, Duration of artificial ventilation, Duration of intensive care stay, Duration of hospital stay
Brief 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.
Interventions
DRUGHydroxychloroquine
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.
DRUGRemdesivir
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
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An open randomized adaptive controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality | 3 weeks | All cause in-hospital mortality |
Secondary
| Measure | Time frame |
|---|---|
| Duration of hospital admittance | 1 month |
| 28 Day mortality | 3 weeks |
| Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen | 3 weeks |
| Occurrence of co-infections | 3 weeks |
| Occurrence of organ dysfunction | 3 months |
| Occurrence and duration of mechanical ventilation | 3 weeks |
| Occurrence and duration of intensive care unit (ICU) treatment | 3 weeks |
Other
| Measure | Time frame |
|---|---|
| Markers of endothelial activation | Throughout hospitalization |
| Markers of platelet activation | Throughout hospitalization |
| Inflammatory and anti-inflammatory mediators as assessed in serum and plasma | Throughout hospitalization |
| Markers of extracellular matrix remodeling | Throughout hospitalization and 3 months after remission |
Countries
Norway
Contacts
Primary ContactPaul Aukrust, MD, Professor
Backup ContactAndreas Barratt-Due, MD, PhD
Outcome results
None listed