Chloroquine Outpatient Treatment Evaluation for HIV-Covid-19

Covid-19 Clinical Trial

— CQOTE  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04360759
• Other study ID #: HIV-COVID-19 CQOTE
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2020
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• HIV

Intervention

Drug:
• Chloroquine or hydroxychloroquine
Chloroquine has in vitro antiviral activity against many viruses, including SARS-CoV-1 and SARS-CoV-2. Chloroquine inhibits coronavirus replication at in vitro concentrations that are not cytotoxic and within a range of blood concentrations achievable during standard antimalarial treatment. Chloroquine inhibits viral replication through interference with glycosylation of coronavirus ACE2 receptors, required for viral entry, and downstream phagolysosome alkalisation, interfering with the low-pH-dependent steps of viral fusion and uncoating. Chloroquine also has anti-inflammatory properties and could provide benefit through this mechanism in Covid-19, where a cytokine storm has been described in critically ill patients. Hydroxychloroquine is a less toxic metabolite of chloroquine, has similar anti-inflammatory properties, and is more potent against SARS-CoV-2 in vitro.

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Cape Town	Western Cape
South Africa	Khayelitsha Hospital	Cape Town	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival at 28 days post-randomization between experimental group and standard of care group	Events defined as Hospitalisation or Death	Day 28
Secondary	Incidence of serious adverse events		Day 28
Secondary	Incidence of adverse events of special interest related to investigational product at time of hospitalisation		Day 28
Secondary	Premature discontinuation of treatment		Day 28
Secondary	Time from treatment initiation to death, ARDS (PF/SF ratio < 300), or mechanical ventilation		Day 28
Secondary	Proportion with moderate and severe ARDS		Day 28
Secondary	Duration of hospitalisation and ICU stay in survivors		Day 28
Secondary	Incidence of Covid-19 in household contacts		Day 28