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 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT04374903
Eligibility Criteria:
Inclusion Criteria:
* Male and non-pregnant female patients 18 years of age or older
* Positive RT-PCR for SARS-CoV-2.
* Fever (oral T≥39 C within 24 hours of enrollment), Tachypnea (resting respiratory rate ≥ 28/min) and/or Oxygen saturation (Sao2) ≤ 93% on room air.
* Ability to read, understand and sign IRB approved informed consent
* Patients on HCQ or HCQ/AZ already are eligible for randomization.
Exclusion Criteria:
* Weight \< 40 kg.
* Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at the screening.
* Subjects with a history of retinopathy, sickle cell disease or trait, psoriasis, porphyria, history of splenectomy, mental illness or uncontrolled seizures disorder, liver cirrhosis, end-stage renal disease or need for renal replacement therapy, Decompensated heart failure, known active tuberculosis or history of incompletely treated tuberculosis, uncontrolled systemic bacterial or fungal infections, active viral infection other than COVID-19, Patients on chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants.
* Allergy to any of the study medications.
* Drug-Drug interaction (after consulting with study PI). For example:
* Drugs that may interact and alter HCQ level: ampicillin, cimetidine, digoxin, statins, cyclosporine, warfarin, fluconazole, within 2 weeks of dosing start, and during the duration of the study.
* Drugs that may interact and alter SIR level: rifampicin, azole antifungals, phenytoin, diltiazem, verapamil, nicardipine, phenobarbital, carbamazepine, within 2 weeks of dosing start, and during the duration of the study.
* Any abnormal baseline laboratory screening tests listed below (Exceptions by study PI may apply if reason explained)
* Liver Child-Pugh grade C (table is included in the study)
* Creatinine \>1.5 mg/dl.
* Hemoglobin for males \<12 g/dl and females \<10 g/dl.
* Platelet count of \<100 X 103/L.
* Cardiac assessment:
* Patients with baseline corrected QT \>450 msec.
* Patients with decompensated heart failure or acute myocardial infarction within the past 30 days of infection.
* Patients with HypoKalemia (\<3.5 mg/dl), HypoCalcemia (\<8.0 mg/dl), HypoMagnesemia (\<1.6mg/dl) will be included after correction.
* Advanced respiratory support (high flow oxygen ≥ 15 L/min, CPAP, non-invasive or invasive mechanical ventilation)
* Any other significant finding based on the judgment of the PI would increase the risk of having an adverse outcome from participating in this study.
* Patients that lack decision-making capacity will not be approached to participate in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04374903
Study Brief:
Protocol Section:
NCT04374903