Chloroquine Outpatient Treatment Evaluation for HIV-Covid-19 (CQOTE)

University of Cape Town (UCT)

Status and phase: Withdrawn; Phase 3

Conditions: HIV; Covid-19

Treatments: Drug: Chloroquine or hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04360759

HIV-COVID-19 CQOTE

Details and patient eligibility

About

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.

Full description

The trial objective is to compare chloroquine (or hydroxychloroquine) versus standard of care for the primary endpoint of hospitalisation or death at 28 days. Consenting adults who meet criteria for a Covid-19 person under investigation and who are ≥18 years, known to be HIV-positive, not requiring immediate hospitalisation and are not at risk of cardiac toxicities related to the study drug will be enrolled. The total sample size will be 560 participants (280 in each arm).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm 1: Chloroquine or hydroxychloroquine

Experimental group

Description:

Loading dose of 4 tablets (150 mg chloroquine base per chloroquine salt tablet; 155 mg chloroquine base per hydroxychloroquine tablet) at time 0 and 6 hours, followed by a maintenance dose of 2 tablets at time 12 hours, and then twice daily for a total of 7 days.

Treatment:

Drug: Chloroquine or hydroxychloroquine

Arm 2: Standard of care

No Intervention group

Description:

This does not include specific therapy under current guidelines.