Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360759
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Sean Wasserman, University of Cape Town

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.

Condition or disease Intervention/treatment Phase
Covid-19 HIV Drug: Chloroquine or hydroxychloroquine Phase 3

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic, multi-centre, open label, randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : July 31, 2021


Arm Intervention/treatment
Experimental: Arm 1: Chloroquine or hydroxychloroquine
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.
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.

No Intervention: Arm 2: Standard of care
This does not include specific therapy under current guidelines.



Primary Outcome Measures :
  1. Event-free survival at 28 days post-randomization between experimental group and standard of care group [ Time Frame: Day 28 ]
    Events defined as Hospitalisation or Death


Secondary Outcome Measures :
  1. Incidence of serious adverse events [ Time Frame: Day 28 ]
  2. Incidence of adverse events of special interest related to investigational product at time of hospitalisation [ Time Frame: Day 28 ]
  3. Premature discontinuation of treatment [ Time Frame: Day 28 ]
  4. Time from treatment initiation to death, ARDS (PF/SF ratio < 300), or mechanical ventilation [ Time Frame: Day 28 ]
  5. Proportion with moderate and severe ARDS [ Time Frame: Day 28 ]
  6. Duration of hospitalisation and ICU stay in survivors [ Time Frame: Day 28 ]
  7. Incidence of Covid-19 in household contacts [ Time Frame: Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360759


Contacts
Layout table for location contacts
Contact: Nompumelelo Maxebengula +27727633386 ext +27727633386 mpumi.maxebengula@uct.ac.za
Contact: Bianca Sossen, MBChB +27763088376 ext +27763088376 bianca.sossen@uct.ac.za

Locations
Layout table for location information
South Africa
Khayelitsha Hospital
Cape Town, Western Cape, South Africa, 7784
Contact: Trevor Ayanda Mnguni, MBChB, FCP(SA)    +27213604530 ext +27213604530    Ayanda.Mnguni@westerncape.gov.za   
Contact: Mpumi Maxebengula, BCom    +27727633386 ext +27727633386    mpumi.maxebengula@uct.ac.za   
Principal Investigator: Graeme Meintjes, PhD         
Sub-Investigator: Trevor Ayanda Mnguni, MBChB, FCP(SA)         
Sub-Investigator: Amy Ward, MBBCh         
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7925
Contact: Bianca Sossen, MBChB, MSc)    +27763088376 ext +27763088376    bianca.sossen@uct.ac.za   
Contact: Mpumi Maxebengula, BCom    +27727633386 ext +27727633386    mpumi.maxebengula@uct.ac.za   
Principal Investigator: Sean Wasserman, MBChB         
Sub-Investigator: Jacob Standler, MBChB         
Sub-Investigator: Bianca Sossen, MBChB, MSc         
Sponsors and Collaborators
University of Cape Town
Investigators
Layout table for investigator information
Principal Investigator: Sean Wasserman, MBChB CIDRI-Africa, University of Cape Town
Principal Investigator: Graeme Meintjes, PhD CIDRI-Africa, University of Cape Town
Layout table for additonal information
Responsible Party: Sean Wasserman, Principal Investigator, University of Cape Town
ClinicalTrials.gov Identifier: NCT04360759    
Other Study ID Numbers: HIV-COVID-19 CQOTE
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data collected from this study may be made available to other international researchers and institutions who are working to control this Public Health Emergency, but in a fully anonymized way. No personal identifiers will be available anywhere in the data. Dates will either not be included or will be shifted by a random interval so as to not make it possible to trace any identity.
Supporting Materials: Study Protocol
Time Frame: Recruitment period is planned for a maximum of 12 months, rate dependent on patient numbers. Additional sites will be opened after initial approvals.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hydroxychloroquine
Chloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Amebicides