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

Institute of Tropical Medicine0 个研究点目标入组 206 人开始时间: 2020年4月1日最近更新: 2020年8月10日

适应症

试验速览

暂无简介。

•- 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

•- 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.

发起方

Institute of Tropical Medicine