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

February 21, 2021 updated by: Tim Richard Edmund Harris, Hamad Medical Corporation

Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

456

Phase

  • Not Applicable

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

  • Qatar
      • Doha, Qatar, 3050
        • Hamad Medical Corporation

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination therapy group
hydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5
Drug: Hydroxychloroquine
Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
Other Names:
  • 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 Names:
  • Zithromax, Azithrocin
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
Drug: Hydroxychloroquine
Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
Other Names:
  • Plaquenil,
Other: Placebo capsules
Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
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
Other: Placebo capsules
Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
Other: Placebo Tablet
Oral, one tablet three times a day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of virologically cured (PCR-negative status) as assessed on day six
Time Frame: Day 6
Days
Day 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
virologic cure on other study days
Time Frame: Day14 and Day 21
Days
Day14 and Day 21
virologic semiquantitative analysis of changing viral load
Time Frame: Day 1 to Day 21
Days
Day 1 to Day 21
proportion of initially symtomatic subjects with disappearance of clinical symptoms
Time Frame: Day14 and Day 21
Days
Day14 and Day 21
proportion of initially asymtomatic subjects with appearance of new clinical symptoms
Time Frame: Day14 and Day 21
Days
Day14 and Day 21
proportions of subjects with potentially medication- related adverse events
Time Frame: 7 day
grades
7 day

Collaborators and Investigators

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

Sponsor

Hamad Medical Corporation

Investigators

  • Principal Investigator: Tim R Harris, Hamad Medical Corporation

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)

April 14, 2020

Primary Completion (Actual)

August 14, 2020

Study Completion (Actual)

August 30, 2020

Study Registration Dates

First Submitted

April 12, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 21, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-05-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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