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

  • Clinicaltrials.gov identifier

    NCT04860284

  • Recruitment Status

    Active, not recruiting

  • First Posted

    April 26, 2021

  • Last update posted

    April 26, 2021

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:Covid19
  • Intervention/Treatment: Drug: Hydroxychloroquine tablets
  • Phase: 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: September 2020
  • Estimated Primary Completion Date: February 2021
  • Actual Study Completion Date: December 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

Outcome Measures

  • 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

Eligibility Criteria

  • 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

Contacts and Locations

Contacts

Locations

Uganda
Namboole COVID-19 treatment unit
Kampala

Sponsors and Collaborators

Makerere University

Investigators

Principal Investigator: Pauline Byakika-Kibwika, PhD Makerere University

More Information

  • Responsible Party: Makerere University
  • ClinicalTrials.gov Identifier: NCT04860284 History of Changes
  • 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
  • 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.: Yes
  • Additional relevant MeSH terms: 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