Chloroquine Outpatient Treatment Evaluation for HIV-Covid-19

• Status: Withdrawn
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Clinical manifestations of Covid-19 are poorly characterised in HIV co-infection, which may predispose to more severe disease. Reducing hospitalisation and severe illness in this population has important individual and public health benefits. The investigators propose a pragmatic multi-centre, randomized controlled trial in South Africa to evaluate the efficacy and safety of chloroquine or hydroxychloroquine to prevent progression of disease and hospitalisation amongst HIV-positive people with Covid-19 not requiring hospitalisation at initial assessment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cape Town
• Treatments: Chloroquine; Hydroxychloroquine

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