Status:
WITHDRAWN
Chloroquine Outpatient Treatment Evaluation for HIV-Covid-19
Lead Sponsor:
University of Cape Town
Conditions:
Covid-19
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 import...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04360759
Start Date
May 1 2020
End Date
June 30 2021
Last Update
August 18 2020
Active Locations (2)
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1
Khayelitsha Hospital
Cape Town, Western Cape, South Africa, 7784
2
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7925