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

• Status: Completed
• Trial end date: 2020-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Azithromycin; Hydroxychloroquine

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