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

Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19

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.

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.

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