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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04860284
Recruitment Status : Active, not recruiting
First Posted : April 26, 2021
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Makerere University

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
Covid19 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.

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Study Type : Interventional  (Clinical Trial)
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 : September 18, 2020
Actual Primary Completion Date : February 9, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


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 Name: HCQ

No Intervention: Control arm
Participants will receive only standard of care treatment for COVID-19



Primary Outcome Measures :
  1. SARS COV-2 viral clearance [ Time Frame: 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 [ Time Frame: From randomization to day 6 ]
    Grade 3 or 4 adverse events

  2. Time to symptom clearance [ Time Frame: Randomization to day 10 ]
    Time from randomization to symptom clearance

  3. Pharmacokinetic-pharmacodynamic model demonstrating drug concentration [ Time Frame: Randomization to day 8 ]
    Exposure-outcome relationship of hydroxychloroquine

  4. Sero-reversion to negative antibody test [ Time Frame: From randomization to day 90 ]
    Antibody sero-reversion



Information from the National Library of Medicine

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

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

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): NCT04860284


Locations
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Uganda
Namboole COVID-19 treatment unit
Kampala, Uganda
Sponsors and Collaborators
Makerere University
Investigators
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Principal Investigator: Pauline Byakika-Kibwika, PhD Makerere University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT04860284    
Other Study ID Numbers: MAKRIF/DVCFA/016/20
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021

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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:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents