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:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT04341727
Eligibility Criteria:
Inclusion Criteria:
* Hospitalization for management of SARS CoV-2 infection
* Positive SARS CoV-2 test
* Age \>=18 years
* Provision of informed consent
* Electrocardiogram (ECG) ≤48 hours prior to enrollment
* Complete blood count, glucose-6 phosphate-dehydrogenase (G6PD), comprehensive metabolic panel and magnesium ≤48 hours prior to enrollment from standard of care.
* If participating in sexual activity that could lead to pregnancy, individuals of reproductive potential who can become pregnant must agree to use contraception throughout the study. At least one of the following must be used throughout the study:
* Condom (male or female) with or without spermicide
* Diaphragm or cervical cap with spermicide
* Intrauterine device (IUD)
* Hormone-based contraceptive
Exclusion Criteria:
* Contraindication or allergy to chloroquine, hydroxychloroquine or azithromycin
* Current use hydroxychloroquine, chloroquine or azithromycin
* Concurrent use of another investigational agent
* Invasive mechanical ventilation
* Participants who have any severe and/or uncontrolled medical conditions such as:
* unstable angina pectoris,
* symptomatic congestive heart failure,
* myocardial infarction,
* cardiac arrhythmias or know prolonged QTc \>470 males, \>480 female on ECG
* pulmonary insufficiency,
* epilepsy (interaction with chloroquine),
* Prior retinal eye disease
* Concurrent malignancy requiring chemotherapy
* Known Chronic Kidney disease, eGFR\<10 or dialysis
* G-6-PD deficiency, if unknown requires G6PD testing prior to enrollment
* Known Porphyria
* Known myasthenia gravis
* Currently pregnant or planning on getting pregnant while on study
* Breast feeding
* AST/ALT \>five times the upper limit of normal ULN\*
* Bilirubin \>five times the ULN\*
* Magnesium \<1.4 mEq/L\*
* Calcium \<8.4mg/dL \>10.6mg/dL\*
* Potassium \<3.3 \>5.5 mEg/L\*
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04341727
Study Brief:
Protocol Section:
NCT04341727