Last Verified: | March/31/2020 |
First Submitted: | March/22/2020 |
Estimated Enrollment Submitted: | March/23/2020 |
First Posted: | March/24/2020 |
Last Update Submitted: | April/9/2020 |
Last Update Posted: | April/13/2020 |
Actual Study Start Date: | March/27/2020 |
Estimated Primary Completion Date: | July/31/2020 |
Estimated Study Completion Date: | October/31/2020 |
Study Type: | Interventional |
Allocation: | Randomized |
: | An open randomized adaptive controlled trial |
Primary Purpose: | Treatment |
Masking: | None (Open Label) |
Arm | Intervention/treatment |
---|---|
Active Comparator: Hydroxychloroquine | |
Active Comparator: Remdesivir | |
Active Comparator: Control group - SoC |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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) |