COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001224-33/DE

Universitätsklinikum Tübingen - Project management,Diane Egger-Adam

diane.egger-adam@uni-tuebingen.de

2020-03-24

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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 hospitalisation QTc interval lower than 450 msec

Respiratory rate >24/min Pregnancy 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

2

Universitätsklinikum Tübingen

18

None

Germany

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

220

Primary efficacy endpoint: Viral clearance defined as time to sustained SARS-CoV-2-specific RNA copy number ≤100, measured by real time reverse-transcription polymerase chain reaction in throat swabs

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"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"}]