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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Other: Placebo Tablet; Drug: Hydroxychloroquine; Drug: Azithromycin; Other: Placebo capsules

• Registration Number: NCT04349592
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-04-12
• Study Start: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Primary Completion: 2020-08-14
• Study Completion: 2020-08-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-21
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 456

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo Tablet	Placebo Cap TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
Combination therapy group	Hydroxychloroquine	hydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5
Combination therapy group	Azithromycin	hydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5
Monotherapy therapy group	Hydroxychloroquine	hydroxychloroquine 200mg TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
Monotherapy therapy group	Placebo capsules	hydroxychloroquine 200mg TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
Control group	Placebo capsules	Placebo Cap TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5

Primary Outcome Measures

Name	Time	Method
Proportion of virologically cured (PCR-negative status) as assessed on day six	Day 6	Days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hamad Medical Corporation; 🇶🇦 Doha, Qatar