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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT04429867
Eligibility Criteria:
Inclusion Criteria:
* Admitted to Wellstar Kennestone Hospital
* Age 18 years or older
* Laboratory-confirmed COVID-19
* At least 1 of the following:
1. Requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from baseline
2. Bilateral infiltrates on CXR or CT of chest
3. Age 65 or older
4. Diabetes
5. Hypertension
6. BMI \> 35
7. Chronic lung disease
8. Cardiovascular disease
9. Chronic kidney disease
10. Cancer (hematologic malignancies, lung cancer, and metastatic disease)
Exclusion Criteria:
* Unable to provide informed consent
* Unable to take oral medication
* Severe/critical COVID-19 disease at presentation
1. Intensive care or intermediate care required at admission or within 48 hours
2. Requiring oxygen supplementation via high flow nasal cannula, bipap, or non-rebreather mask at admission or within 48 hours
* Likelihood of survival \<48 hours in the opinion of the primary physician or transitioned to comfort measures within 48 hours of admission
* Inability to take hydroxychloroquine due to allergy, QTc \> 500 ms (male) or 520 ms (female) prior to initiation of hydroxychloroquine, pre-existing retinopathy, known G6PD deficiency, known porphyria, or significant drug- drug interactions
* Pregnant or breastfeeding
* Severe liver disease (Child-Pugh Class C)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04429867
Study Brief:
Protocol Section:
NCT04429867