COVID-19 MedDRA version: 20.0 Level: HLGT Classification code 10047438 Term: Viral infectious disorders System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Institute of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged = 18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if 10 doses of HC, each taken 12 hours apart, increase the proportion of COVID-19 patients who have a negative nasopharyngeal RT-PCR for SARS-CoV-2 by day 7 post diagnosis in the HC arm compared to the no-HC arm.;Secondary Objective: Secondary objective 1: To assess the safety of HC in COVID-19 patients treated in the ambulatory setting Secondary objective 2: To assess the clinical efficacy of HC in COVID-19 patients Secondary endpoint 3:To assess if 10 doses of HC, each taken 12 hours apart, increase the proportion of COVID-19 patients who have a negative COVIDAM, Protocol version 3.0, dated 16/April/2020 9/49 nasopharyngeal RT-PCR for SARS-CoV-2 by day 7 post onset of symptoms (POS) in the HC arm compared to the no-HC arm. Secondary Objective 4: To assess if 10 doses of HC, each taken 12 hours apart, increase the proportion of COVID-19 patients who have a negative nasal AND salivary RT-PCR for SARS-CoV-2 by day 7 post diagnosis in the HC arm compared to the no-HC arm.;Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: Day 7 post diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint 1: frequency and pattern of reported adverse events, adverse reactions, Serious Adverse Events, Serious adverse reactions, and SUSARs.. Secondary endpoint 2: pattern and duration of clinical symptoms, as reported by the patients; rate of hospital admission during follow-up. Secondary endpoint 3: proportion of participants with a negative nasopharyngeal sample* by day 7 POS * 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 Secondary endpoint 4: proportion of participants with a negative nasal swab + saliva sample* by day 7 post diagnosis * defined by a negative RT-PCR on a self-taken nasal swab AND saliva sample of two subsequent study visits. The date of the first pair of negative samples will then be taken as the date of negativity;Timepoint(s) of evaluation of this end point: Secondary endpoint 1: visit 2 (day 3), visit 3 (day 6), visit 4 (day 9), visit 5 (day 13) ,visit 6 (day 17) and visit 7 (day 21) Secondary endpoint 2: visit 2 (day 3), visit 3 (day 6), visit 4 (day 9), visit 5 (day 13) ,visit 6 (day 17) and visit 7 (day 21) Secondary endpoint 3: Day 7 Post onset of symptoms Secondary endpoint 4: Day 7 post diagnosis | — |
Countries
Belgium
Contacts
Public ContactYven Van Herrewege
ITM Clinical Trial Unit
Outcome results
None listed