COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001456-18/CZ

Not reported

Not reported

2020-04-08

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1) adult (>18 years) 2) within 24 hours of admission to intensive care unit 3) proven or suspected COVID-19 infection

1) Symptoms of febrile disease for ≥1 week at enrolement 2) Pregnancy or inability/unwillingness to perform pregnancy test at and 28 days after enrolment 3) Treatment limitations in place or moribund patients 4) Allergy, intolerance or contraindication to any study drug, incl. long QT syndromes, myasthenia gravis, allergies or known deficiency of glucose-6-phosphate dehydrogenase 5) Known HIV positivity 6) Significant liver disease such as cirrhosis Child-Pugh C or active hepatitis B or C 7) Known stage IV chronic kidney disease, on dialysis at enrolment or imminent need of it 8) Participation in another outcome-based interventional trial within last 30 days 9) Patients taking Hydroxychloroquine for other indication than to treat COVID-19. Criteria for withdrawal from the study: 1) Consent withdrawal by study subject 2) In case – in the opinion of the investigator – the study procedures are considered unsafe for the study subject or the risks outweigh the potential benefits

3

Nadační fond Donatio intensivistam

18

100

Czech Republic

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

240

Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14.

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

Phase 3

[{"arm_notes": "New Type treatment : hydroxychloroquine sulfate", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "New Type treatment : AZITHROMYCIN MONOHYDRATE", "treatment_id": 165, "treatment_name": "Azithromycin", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": null, "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]