COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04342221

Benjamin Mordmüller, Prof.

Diane Egger-Adam, diane.egger-adam@uni-tuebingen.de (PI email not reported)

2020-04-10

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - written informed consent - age above 18 years - women of childbearing age only: must agree to practice continuous effective contraception for the duration of the study (a method which results in a failure rate less than 1% per year) - disease severe enough to require hospitalization - qtc interval lower than 450 msec

- respiratory rate >24/min - pregnancy (tested with a pregnancy test) or lactation - weight <50 kg - hemodynamic/rhythm instability - acute myocardial infarction type 1 - use of concomitant medications that prolong the qt/qtc interval. - any regular concomitant medication which is contraindicated in the use together with hcq - hypersensitivity to hydroxychloroquine, chloroquine or other 4-aminoquinolines - pre-existing retinopathy or maculopathy - known glucose-6-phosphate dehydrogenase deficiency (haemolytic anaemia, favism) - haematopoietic systems diseases - myasthenia gravis - any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data additionally, clinical evaluation and laboratory values inform eligibility of the patient based on the judgement of the study team. these may include: total bilirubin, transaminase level, albumin concentration, haematological parameters, troponin and bnp levels, creatinine, creatinine kinase levels.

2

University Hospital Tuebingen

18

100

Germany

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

30

Effect of HCQ on in vivo viral clearance

None

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]