Chloroquine Outpatient Treatment Evaluation for HIV-Covid-19

Last updated: August 14, 2020
Sponsor: University of Cape Town
Overall Status: Trial Not Available

Phase

3

Condition

Hiv

Covid-19

Treatment

N/A

Clinical Study ID

NCT04360759
HIV-COVID-19 CQOTE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Covid-19 diagnosed > 5 days prior to randomization;

  • Active tuberculosis;

  • Need for concomitant drugs that are contraindicated with the use ofChloroquine/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 orany other 4-aminoquinolone or another experimental investigational medicinal productthat is likely to interfere with the study medication. Note: Pregnancy and breastfeeding are not exclusions for entry

Study Design

Study Start date:
May 01, 2020
Estimated Completion Date:
June 30, 2021

Study 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).

Connect with a study center

  • Groote Schuur Hospital

    Cape Town, Western Cape 7925
    South Africa

    Site Not Available

  • Khayelitsha Hospital

    Cape Town, Western Cape 7784
    South Africa

    Site Not Available

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