Clinical trial NCT04360759: Chloroquine Outpatient Treatment Evaluation for HIV-Covid-19
Official title: Multi-centre Randomised Controlled Trial of Chloroquine/Hydroxychloroquine Versus Standard of Care for Treatment of Mild Covid-19 in HIV-positive Outpatients in South Africa
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Covid-19
HIV
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, multi-centre, open label, randomised controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

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

Primary outcomes:
measure: Event-free survival at 28 days post-randomization between experimental group and standard of care group
timeFrame: Day 28
Secondary outcomes:
measure: Incidence of serious adverse events
timeFrame: Day 28
measure: Incidence of adverse events of special interest related to investigational product at time of hospitalisation
timeFrame: Day 28
measure: Premature discontinuation of treatment
timeFrame: Day 28
measure: Time from treatment initiation to death, ARDS (PF/SF ratio < 300), or mechanical ventilation
timeFrame: Day 28
measure: Proportion with moderate and severe ARDS
timeFrame: Day 28
measure: Duration of hospitalisation and ICU stay in survivors
timeFrame: Day 28
measure: Incidence of Covid-19 in household contacts
timeFrame: Day 28
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Khayelitsha Hospital
state: Western Cape
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
Study officials:
affiliation: CIDRI-Africa, University of Cape Town
name: Sean Wasserman, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: CIDRI-Africa, University of Cape Town
name: Graeme Meintjes, PhD
role: PRINCIPAL_INVESTIGATOR
References: