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

NCT ID: NCT04349592

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-14
• Study Completion Date: 2020-08-30

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Combination therapy group

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

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days

Azithromycin

Intervention Type: DRUG

Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5.

Monotherapy therapy group

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

Group Type: ACTIVE_COMPARATOR

Hydroxychloroquine

Intervention Type: DRUG

Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days

Placebo capsules

Intervention Type: OTHER

Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.

Control group

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

Group Type: PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type: OTHER

Oral, one tablet three times a day for 7 days

Placebo capsules

Intervention Type: OTHER

Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.

Interventions

Hydroxychloroquine

Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days

Intervention Type: DRUG

Azithromycin

Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5.

Intervention Type: DRUG

Placebo Tablet

Oral, one tablet three times a day for 7 days

Intervention Type: OTHER

Placebo capsules

Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.

Intervention Type: OTHER

Other Intervention Names

Plaquenil,; Zithromax, Azithrocin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Tim Richard Edmund Harris

Professor Tim Richard Edmund Harris

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tim R Harris

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation

Locations

Hamad Medical Corporation

Doha, , Qatar

Countries

Qatar

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Other Identifiers

MRC-05-001

Identifier Type: -

Identifier Source: org_study_id