Status:
COMPLETED
Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
Lead Sponsor:
Hamad Medical Corporation
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
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 C...
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT04349592
Start Date
April 14 2020
End Date
August 30 2020
Last Update
February 23 2021
Active Locations (1)
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1
Hamad Medical Corporation
Doha, Qatar, 3050