Hydroxychloroquine for Treatment of Non-Severe COVID-19 (HONEST)

April 23, 2021 updated by: Makerere University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Namboole COVID-19 treatment unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS COV-2 viral clearance
Time Frame: From randomization to day 6
Attaining a negative PCR- test result i.e. 100% viral clearance
From randomization to day 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical and laboratory adverse events
Time Frame: From randomization to day 6
Grade 3 or 4 adverse events
From randomization to day 6
Time to symptom clearance
Time Frame: Randomization to day 10
Time from randomization to symptom clearance
Randomization to day 10
Pharmacokinetic-pharmacodynamic model demonstrating drug concentration
Time Frame: Randomization to day 8
Exposure-outcome relationship of hydroxychloroquine
Randomization to day 8
Sero-reversion to negative antibody test
Time Frame: From randomization to day 90
Antibody sero-reversion
From randomization to day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2020

Primary Completion (Actual)

February 9, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

April 23, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAKRIF/DVCFA/016/20

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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