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

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: 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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Hydroxychloroquine Drug: Azithromycin Other: Placebo Tablet Other: Placebo capsules Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blinded trial
Primary Purpose: Treatment
Official Title: Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
Actual Study Start Date : April 14, 2020
Actual Primary Completion Date : August 14, 2020
Actual Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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
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 Name: 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 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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of virologically cured (PCR-negative status) as assessed on day six [ Time Frame: Day 6 ]
    Days


Secondary Outcome Measures :
  1. virologic cure on other study days [ Time Frame: Day14 and Day 21 ]
    Days

  2. virologic semiquantitative analysis of changing viral load [ Time Frame: Day 1 to Day 21 ]
    Days

  3. proportion of initially symtomatic subjects with disappearance of clinical symptoms [ Time Frame: Day14 and Day 21 ]
    Days

  4. proportion of initially asymtomatic subjects with appearance of new clinical symptoms [ Time Frame: Day14 and Day 21 ]
    Days

  5. proportions of subjects with potentially medication- related adverse events [ Time Frame: 7 day ]
    grades


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT04349592


Locations
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Qatar
Hamad Medical Corporation
Doha, Qatar, 3050
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
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Principal Investigator: Tim R Harris Hamad Medical Corporation
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tim Richard Edmund Harris, Professor Tim Richard Edmund Harris, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT04349592    
Other Study ID Numbers: MRC-05-001
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Tim Richard Edmund Harris, Hamad Medical Corporation:
Covid19
Qatar
Coronavirus
Hydroxychloroquine
Respiratory disease
 Pandemic
Azithromycin
Viral Load
Emergency Department
SARS-CoV-2
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
Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents