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

Hamad Medical Corporation (HMC)

Status: Completed

Conditions: Covid19

Treatments: Drug: Hydroxychloroquine; Other: Placebo capsules; Other: Placebo Tablet; Drug: Azithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04349592

MRC-05-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 456 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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456 participants in 3 patient groups, including a placebo group

Combination therapy group

Experimental group

Description:

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

Treatment:

Drug: Azithromycin

Drug: Hydroxychloroquine

Monotherapy therapy group

Active Comparator group

Description:

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

Treatment:

Other: Placebo capsules

Drug: Hydroxychloroquine

Control group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo capsules

Other: Placebo Tablet