Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT04363203
Eligibility Criteria:
Inclusion Criteria:
* willingness to take the study drug and ability to take oral medications
* able to be contacted by phone
* willing and able to give informed consent for participation in the study and agrees with its conduct and willing to email the study team a picture of their consent form
Exclusion Criteria:
Exclusion Criteria Based on National VA Data:
We will exclude individuals based on the following national VA data and chart review criteria:
* eGFR \<30mL/min or dialysis
* aspartate transaminase (AST) or alanine transaminase (ALT) \>5 times the upper limit of normal or cirrhosis in past 2 years
* hypersensitivity to chloroquine, hydroxychloroquine or other 4-aminoquinolines (e.g., amodiaquine), azithromycin or macrolides
* already taking hydroxychloroquine or azithromycin
* congestive heart failure with an ejection fraction (EF) \<35% in past 2 years or hospitalization within past 6 months
* concomitant treatment with any QT prolonging drug
* history of cardiac arrest, ventricular fibrillation or ventricular tachycardia in past 5 years
* QT prolongation on any ECG in past 5 years
* potassium \<3.5 meq/l in labs in past 2 years
* magnesium\< 1/5 meq/l in any lab in past 2 years
* any patient who has not had follow-up with their primary care doctors in past 2 years
* any Veteran who cannot follow-up such as those with dementia, home based primary care or those with active psychosis documented in past 2 years
* G6PD deficiency
Exclusions Based on Baseline Interview:
* any female who is breastfeeding or pregnant or planning to become pregnant.
* any Veteran who receives most of their care in non-VA settings
* Veteran enrolled in another COVID Trial
* Veteran received a prescription for azithromycin and hydroxychloroquine
* Veteran allergic to azithromycin and or hydroxychloroquine
* Veteran receiving QT prolonging drugs from non-VA pharmacy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
216 Months
Study:
NCT04363203
Study Brief:
Protocol Section:
NCT04363203