An open label single center randomized controlled trial to evaluate the effect of hydroxychloroquine on viral shedding in mild COVID-19

Phase 1

• Conditions: COVID-19; MedDRA version: 20.0Level: HLGTClassification code 10047438Term: Viral infectious disordersSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001417-21-BE
• Lead Sponsor: Institute of Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-01
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

- 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 206
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified