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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT04336332
Eligibility Criteria:
Inclusion Criteria:
* Patients with proven SARS-CoV-2 infection by an accepted assay with symptoms consistent with COVID-19
* Ability to measure and quantify viral load by quantitative PCR
* Age 18 to 89
* Ability to swallow oral medications
* Patients must read, understand and sign IRB approved informed consent
Exclusion Criteria:
* Pregnancy or women who are breast feeding
* Two consecutive negative assays for SARS-CoV-2 infection
* Patients that lack decision-making capacity will not be approached to participate in this study
* Inability to tolerate oral medications
* Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate
* QTc interval \> 470 mSEC
* History of ongoing ventricular cardiac dysrhythmias of grade 2 as described by NCI CTCAE 5.0 criteria
* History of serious ventricular arrhythmia (VT or VF \> 3 beats in a row)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04336332
Study Brief:
Protocol Section:
NCT04336332