COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001417-21/BE

ITM Clinical Trial Unit - Yven Van Herrewege

yvanherrewege@itg.be

2020-04-01

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

- Aged ≥ 18 and < 65 years old - Confirmed symptomatic or asymptomatic COVID-19 as defined by a laboratory diagnosis of SARS-CoV-2 on a respiratory sample within the previous 72 hours - If symptomatic, having COVID-19 symptoms since less than 72 hours (cough, throat ache, fever, dyspnea) at the time of enrollment. - Able and willing to provide written informed consent. - Able to safely attend, with individual transportation, scheduled follow-up visits at ITM.

- Need of hospitalization before or at enrollment visit (visit 1) - Known contra-indication to HC (hypersensitivity to 4-aminoquinoline compounds, ocular retinopathy, epilepsy, diabetes) - Pregnancy or breast-feeding - Use of any other (experimental) drug aiming to treat COVID-19 - Use of any treatment with potential interaction with HC and flagged “red” or “orange” in the list of drug interactions published on the reference website http://www.covid19-druginteractions.org/ (accessed on 30/03/2020). This is a dynamic list which is being updated as new information becomes available. The most recent update of the list will be used. Antacids are flagged orange but can be used if taken at least 4h before or 4h after HC.

2

Institute of Tropical Medicine

18

65

Belgium

Mild disease at enrollment

1: Mild disease at enrollment

206

proportion of participants with a negative nasopharyngeal sample* by day 7 post diagnosis * defined by a negative RT-PCR on a nasopharyngeal swab of two subsequent study visits. The date of the first negative sample will then be taken as the date of negativity

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2

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