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Qatar Prospective RCT Of Therapy Eliminating Covid Transmission (Q-PROTECT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04349592
Recruitment Status : Not yet recruiting
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Tim Richard Edmund Harris, Hamad Medical Corporation

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 + Azithromycin Drug: Hydroxychloroquine + Placebo Other: Placebo + Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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: Qatar Prospective RCT Of Therapy Eliminating Covid Transmission
Estimated Study Start Date : April 14, 2020
Estimated Primary Completion Date : May 14, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HC/AZ
Hydroxychloroquine 200 mg oral tablet three times daily for 7 days + Azithromycin 500 mg ( 2 caps) oral capsules on day one then 250 mg ( 1 cap) daily from day 2-5.
Drug: Hydroxychloroquine + Azithromycin
Hydroxychloroquine 200 mg oral tablet three times daily for 7 days + Azithromycin 500 mg ( 2 caps) oral capsules on day one then 250 mg ( 1 cap) daily from day 2-5.
Other Name: HC/AZ

Placebo Comparator: HC/placebo
Hydroxychloroquine 200 mg oral tablet three times daily for 7 days + Placebo oral capsules 2 capsules day one then 1 cap day 2-5.
Drug: Hydroxychloroquine + Placebo
Hydroxychloroquine 200 mg oral tablet three times daily for 7 days + Placebo oral capsules 2 capsules day one then 1 cap day 2-5.
Other Name: HC/Placebo

Control
Placebo oral 1 tablet three times daily for 7days + Placebo oral capsules 2 capsules day one then 1cap day 2-5.
Other: Placebo + Placebo
Placebo oral 1 tablet three times daily for 7days + Placebo oral capsules 2 capsules day one then 1cap day 2-5.
Other Name: Control




Primary Outcome Measures :
  1. Proportion of virologically cured (no virus detected) cases at day 6 [ Time Frame: Day 6 ]
    Days


Secondary Outcome Measures :
  1. The dichotomous virologic shedding endpoint as assessed at two weeks after study entry [ Time Frame: 2 weeks ]
    Days

  2. Quantitative viral load (assessed with each virology testing set) [ Time Frame: Day 1 to 21 ]
    Days



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:

  • 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
Publications:

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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: April 16, 2020
Last Verified: April 2020
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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Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents