COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000982-18/NO

Oslo university hospital - Sect. Clin. Imm. & Infect. Diseases

andreas.barrattdue@gmail.com

2020-03-24

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

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 and hypersensitivity to any of the components of the available study drug. 5. Pregnancy or breast feeding 6. Any reason why, in the opinion of the investigators, the patient should not participate 7. Participation in a potentially confounding drug or device trial during the course of the study 8. Prolonged QTc interval (>470 ms) 9. Already receiving any of the study drugs 10. Patients with psoriasis 11. Patients on concomitant medication which is part of the list of prohibited medications have to be excluded from the current study (see protocol section 4.3)

3

Oslo University Hospital

18

None

Norway

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

1218

All-cause in-hospital mortality.

Declared number of arm (4.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]