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HONEST: Hydroxychloroquine for Treatment of Non-Severe COVID-19

Sponsor
Makerere University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04860284
Collaborator
(none)
105
Enrollment
1
Location
2
Arms
14.4
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Currently there are no proven treatments for COVID-19 and current standard therapy is supportive care with oxygen supplementation and treatment of symptoms. Several re-purposed and new drugs have been investigated but none is conclusive for efficacy against COVID-19 .Both Hydroxychloroquine(HCQ) and Chloroquine(CQ) have demonstrated activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and have been investigated in small clinical trials with contradicting reports on their benefits or harm in treatment of COVID-19 .Several authors agree that the use of HCQ for treatment of COVID-19 needs to be assessed in large randomized controlled trials

Condition or Disease Intervention/Treatment Phase
  • Drug: Hydroxychloroquine tablets
 Phase 2

Detailed Description

Currently there are no proven treatments for COVID-19 and current standard therapy is supportive care with oxygen supplementation and treatment of symptoms. Several re-purposed and new drugs have been investigated but none is conclusive for efficacy against COVID-19.These include the antimalarial drugs- chloroquine(CQ) and hydroxychloroquine(HCQ), antivirals such as remdesivir and favipiravir and antiretroviral combination therapies such as lopinavir/ritonavir. Although hydroxychloroquine and chloroquine are readily accessible in Uganda and could be explore for treatment of COVID-19,current data regarding their efficacy and safety is scanty.

It is necessary to determine whether HCQ can be useful for treatment of Ugandan patients with COVID-19 for the following reasons : Firstly, the Ugandan population expresses a high level of variability with a younger population with more than 50% under the age of 15 years. Secondly, the population with co-morbid conditions like diabetes mellitus ,hypertension and cardiovascular disease is significantly lower compared to higher income countries. Preliminary data from the first 52 COVID-19 patients in Uganda treated with HCQ demonstrated faster symptom resolution although this did not reach statistical significance. Lastly, HCQ has not been tested in mild-moderate disease where hospitalization is not necessary and we therefore do not know whether it can lead to faster viral clearance, slow disease progression and reduce time to symptom clearance. Our main aim will be to determine if hydroxychloroquine can lead to faster viral clearance.

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of Hydroxychloroquine for the Treatment Of Non-Severe COVID-19 in Adults in Uganda: A Randomized Open Label Phase II Clinical Trial
Actual Study Start Date :
Sep 18, 2020
Actual Primary Completion Date :
Feb 9, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention arm

Participants will receive 400mg of hydroxychloroquine tablets 12-hourly on day 1 and 200mg 12-hourly on day 2 to day 5 in addition to standard of care treatment for COVID-19

Drug: Hydroxychloroquine tablets
Hydroxychloroquine tablets 400mg given orally 12 hourly on day 1 and 200mg 12 hourly on day 2 to 5
Other Names:
  • HCQ

    		•
    No Intervention: Control arm

    Participants will receive only standard of care treatment for COVID-19

    Outcome Measures

    Primary Outcome Measures

    1. SARS COV-2 viral clearance [From randomization to day 6]

      Attaining a negative PCR- test result i.e. 100% viral clearance

    Secondary Outcome Measures

    1. Clinical and laboratory adverse events [From randomization to day 6]

      Grade 3 or 4 adverse events

    2. Time to symptom clearance [Randomization to day 10]

      Time from randomization to symptom clearance

    3. Pharmacokinetic-pharmacodynamic model demonstrating drug concentration [Randomization to day 8]

      Exposure-outcome relationship of hydroxychloroquine

    4. Sero-reversion to negative antibody test [From randomization to day 90]

      Antibody sero-reversion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with a confirmed positive Polymerase chain reaction(PCR) test for SARS COV-2

    • Adults of ≥ 18 years

    • Evidence of a personally signed and dated informed consent document indicating that the participant(or their legal representative) has been informed of all pertinent aspects of the study

    Exclusion Criteria:

    • Patients with contraindication to the use of hydroxychloroquine e.g. known allergy to hydroxychloroquine

    • Patients enrolled in another interventional study which may interfere with study results

    • Patients on medication that are known to have clinically significant interactions with the study drug e.g. digoxin, piperaquine, lumefantrine.

    • Patients presenting with severe/critically ill COVID-19 (World Health Organization Ordinal scale for clinical improvement score of 5 or more)

    • Patients with a fever( temperature ≥ 37.5 degrees centigrade) and a positive rapid diagnostic test (RDT) result for malaria

    • Patients with corrected QT interval (QTc) prolongation of > 450ms for males and >470ms for females

    • Pregnant or breastfeeding women

    • Patients on chronic hydroxychloroquine use

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Namboole COVID-19 treatment unit Kampala Uganda

    Sponsors and Collaborators

    • Makerere University

    Investigators

    • Principal Investigator: Pauline Byakika-Kibwika, PhD, Makerere University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Makerere University
    ClinicalTrials.gov Identifier:
    NCT04860284
    Other Study ID Numbers:
    • MAKRIF/DVCFA/016/20
    First Posted:
    Apr 26, 2021
    Last Update Posted:
    Apr 26, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    COVID-19
    Hydroxychloroquine

    Study Results

    No Results Posted as of Apr 26, 2021