Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT04360759
Eligibility Criteria:
Inclusion Criteria:
* Tested for Covid-19 at a trial recruitment site as an outpatient;
* Age 18 years or older;
* Not requiring immediate hospitalisation;
* Mild disease, defined as respiratory rate \<25/min, pulse rate \<120/min, SpO2 \>94%;
* HIV-positive by rapid test or documented history;
* Suspected or confirmed Covid-19;
* Signed informed consent.
Exclusion Criteria:
* Covid-19 diagnosed \> 5 days prior to randomization;
* Active tuberculosis;
* Need for concomitant drugs that are contraindicated with the use of Chloroquine/hydroxychloroquine;
* QTcF interval \> 480 ms;
* Known glomerular filtration rate \< 10 ml/min;
* Known with glucose-6-phosphate dehydrogenase deficiency (G6PD);
* Previous adverse drug reaction to investigational product;
* Concurrent involvement in other research or use of chloroquine, hydroxychloroquine or any other 4-aminoquinolone or another experimental investigational medicinal product that is likely to interfere with the study medication.
Note: Pregnancy and breastfeeding are not exclusions for entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04360759
Study Brief:
Protocol Section:
NCT04360759