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 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT04349592
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04349592
Study Brief:
Protocol Section:
NCT04349592