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Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19

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ClinicalTrials.gov Identifier: NCT04349592
Recruitment Status : Completed
First Posted : April 16, 2020
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Tim Richard Edmund Harris, Hamad Medical Corporation

Tracking Information
First Submitted Date  ICMJE April 12, 2020
First Posted Date  ICMJE April 16, 2020
Last Update Posted Date February 23, 2021
Actual Study Start Date  ICMJE April 14, 2020
Actual Primary Completion Date August 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2020)
Proportion of virologically cured (PCR-negative status) as assessed on day six [ Time Frame: Day 6 ]
Days
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
Proportion of virologically cured (no virus detected) cases at day 6 [ Time Frame: Day 6 ]
Days
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2020)
  • virologic cure on other study days [ Time Frame: Day14 and Day 21 ]
    Days
  • virologic semiquantitative analysis of changing viral load [ Time Frame: Day 1 to Day 21 ]
    Days
  • proportion of initially symtomatic subjects with disappearance of clinical symptoms [ Time Frame: Day14 and Day 21 ]
    Days
  • proportion of initially asymtomatic subjects with appearance of new clinical symptoms [ Time Frame: Day14 and Day 21 ]
    Days
  • proportions of subjects with potentially medication- related adverse events [ Time Frame: 7 day ]
    grades
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • The dichotomous virologic shedding endpoint as assessed at two weeks after study entry [ Time Frame: 2 weeks ]
    Days
  • Quantitative viral load (assessed with each virology testing set) [ Time Frame: Day 1 to 21 ]
    Days
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
Official Title  ICMJE Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
Brief Summary Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.
Detailed Description Reducing viral load is potentially key to reducing viral transmission between humans. Observational data suggests HC and AZ may reduce the viral load. In this study we will randomise ambulatory patients with Covid 19 (confirmed by PCR in combination with clinical symptoms) to receive HC/AZ or HC/placebo or placebo for 7 days. On days 2-14, participants will be reviewed by a member of the research team and samples will be obtained for viral load, an ECG recorded and physical examination performed. On days 15-20, participants will be reviewed by telephone using a semi structured questionnaire. On day 21 participants will be examined in person and an oronasopharyngeal swabs obtained for PCR analysis. Participants will be followed for 6 months via their medical records.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blinded trial
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Hydroxychloroquine
    Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
    Other Name: Plaquenil,
  • Drug: Azithromycin
    Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
    Other Name: Zithromax, Azithrocin
  • Other: Placebo Tablet
    Oral, one tablet three times a day for 7 days
  • Other: Placebo capsules
    Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
Study Arms  ICMJE
  • Experimental: Combination therapy group
    hydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5
    Interventions:
    • Drug: Hydroxychloroquine
    • Drug: Azithromycin
  • Active Comparator: Monotherapy therapy group
    hydroxychloroquine 200mg TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
    Interventions:
    • Drug: Hydroxychloroquine
    • Other: Placebo capsules
  • Placebo Comparator: Control group
    Placebo Cap TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
    Interventions:
    • Other: Placebo Tablet
    • Other: Placebo capsules
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2020)
456
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 30, 2020
Actual Primary Completion Date August 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is in HMC facility for low-acuity, Covid-positive patients being quarantined.
  • Positive Covid test on qualitative assay used during routine care (i.e. not as part of Q-PROTECT)
  • Age at least 18

Exclusion Criteria:

  • Treating physician judges patient not appropriate for study participation for any reason
  • Age <18
  • Breastfeeding or pregnancy (patient-reported pregnancy status is sufficient)
  • Hypersensitivity to chloroquine or HC or AZ
  • History of or known QT prolongation

    • EKG required before study entry and on each visit during the subject's first seven days on pro-tocol, during the time period HC is being taken
    • Baseline QTc >480 if QRS width normal; QTc >510 if QRS >120
  • Known G6PD deficiency, porphyria, or retinopathy (eye exam prior to study entry)
  • Known hepatic or renal disease (or abnormality on liver or renal function testing at study day 1)
  • Low magnesium or low potassium (by testing on day 1)
  • Current (pre-study) therapy with antimalarial or dapsone
  • Current (pre-study) therapy with antiviral agents (e.g. oseltamivir)
  • Tisdale36 score exceeding 6 as tallied below (based on ACC recommendations)*

    • 1 point each: age>67, female sex, or being on loop diuretic
    • 2 points each: serum potassium <3.6, QTc>449, acute myocardial infarction
    • 3 points each: sepsis, heart failure, QT-prolonging drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Qatar
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04349592
Other Study ID Numbers  ICMJE MRC-05-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tim Richard Edmund Harris, Hamad Medical Corporation
Study Sponsor  ICMJE Hamad Medical Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tim R Harris Hamad Medical Corporation
PRS Account Hamad Medical Corporation
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP