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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Hydroxychloroquine
Azithromycin
Placebo Tablet
Placebo capsules
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Covid19, Qatar, Coronavirus, Hydroxychloroquine, Respiratory disease, Pandemic, Azithromycin, Viral Load, Emergency Department, SARS-CoV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamad Medical Corporation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Combination therapy group

Monotherapy therapy group

Control group

Arm Description

hydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5

hydroxychloroquine 200mg TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5

Placebo Cap TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5

Outcomes

Primary Outcome Measures

Proportion of virologically cured (PCR-negative status) as assessed on day six
Days

Secondary Outcome Measures

virologic cure on other study days
Days
virologic semiquantitative analysis of changing viral load
Days
proportion of initially symtomatic subjects with disappearance of clinical symptoms
Days
proportion of initially asymtomatic subjects with appearance of new clinical symptoms
Days
proportions of subjects with potentially medication- related adverse events
grades

Full Information

First Posted
April 12, 2020
Last Updated
February 21, 2021
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04349592
Brief Title
Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
Official Title
Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
August 14, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Covid19, Qatar, Coronavirus, Hydroxychloroquine, Respiratory disease, Pandemic, Azithromycin, Viral Load, Emergency Department, SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blinded trial
Allocation
Randomized
Enrollment
456 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination therapy group
Arm Type
Experimental
Arm Description
hydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5
Arm Title
Monotherapy therapy group
Arm Type
Active Comparator
Arm Description
hydroxychloroquine 200mg TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo Cap TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
Plaquenil,
Intervention Description
Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Zithromax, Azithrocin
Intervention Description
Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
Intervention Type
Other
Intervention Name(s)
Placebo Tablet
Intervention Description
Oral, one tablet three times a day for 7 days
Intervention Type
Other
Intervention Name(s)
Placebo capsules
Intervention Description
Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
Primary Outcome Measure Information:
Title
Proportion of virologically cured (PCR-negative status) as assessed on day six
Description
Days
Time Frame
Day 6
Secondary Outcome Measure Information:
Title
virologic cure on other study days
Description
Days
Time Frame
Day14 and Day 21
Title
virologic semiquantitative analysis of changing viral load
Description
Days
Time Frame
Day 1 to Day 21
Title
proportion of initially symtomatic subjects with disappearance of clinical symptoms
Description
Days
Time Frame
Day14 and Day 21
Title
proportion of initially asymtomatic subjects with appearance of new clinical symptoms
Description
Days
Time Frame
Day14 and Day 21
Title
proportions of subjects with potentially medication- related adverse events
Description
grades
Time Frame
7 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim R Harris
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad Medical Corporation
City
Doha
ZIP/Postal Code
3050
Country
Qatar

12. IPD Sharing Statement

Plan to Share IPD
No
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Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19

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