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 @ 4:24 AM
Ignite Modification Date:
2025-12-25 @ 4:24 AM
NCT ID:
NCT04351620
Eligibility Criteria:
Inclusion Criteria:
* Being tested positive for SARS-Cov-2 in outpatient setting in drive-thru, ED, or ambulatory clinics at the University of Chicago within 72 hours of enrollment.
* Age \>18
* Fever \>100.4 F by any conventional clinical method (forehead, tympanic, oral, axillary, rectal) within 48h prior to enrollment
* Mild COVID-19, defined as the presence of any symptom consistent with an upper respiratory tract infection, including dry cough, sore throat, nasal congestion, fatigue, myalgia, headaches.
Subjects must meet all the above-mentioned criteria, in addition to at least one of the following criteria:
* Age \> 55
* Pre-existing pulmonary disease: airway diseases (asthma, chronic obstructive pulmonary disease, bronchiectasis, cystic fibrosis), history of active or treated lung cancer, history of pneumectomy, interstitial lung diseases, pulmonary hypertension, sleep apnea.
* Diabetes: uncontrolled or controlled diabetes
* Hypertension
* Chronic kidney disease stage 1-3
* History of cardiovascular disease with an electrocardiogram available to the physician-investigator through the subject's electronical medical record within the past thirty days showing a normal QT interval (QT \< 500 ms).
* History of immunosuppression
* Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
* At least one fever every 24 hours for \> 72h
Exclusion Criteria:
* Participation in any other clinical trial of an experimental agent treatment for COVID-19
* Current hospitalization
* Known hypersensitivity to hydroxyxhloroquine or chloroquine
* Known chronic kidney disease, stage 4-5, or receiving dialysis
* History of retinal disease
* History of uncontrolled hypertension, defined as systolic blood pressure \> 180 mmHg and or diastolic blood pressure \> 100 mmHg at the most recent physical medical encounter or by patient report.
* History of QT prolongation (QT \> 500 ms) or history of Torsades de Pointes
* History of arrhythmias
* Current use of loop diuretics and potassium supplementation or documented history of hypokalemia.
* Pregnancy and lactation
* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Current use of any of the following medications: flecainide (Tambocor), amiodarone (Cordarone, Pacerone), digoxin (Digox, Digitek), procainamide (Procan, Procanbid), propafenone (Rythmal), antiepileptic agents (phenytoin, phenobarbital, valproic acid, lamotrigine, topiramate), tamoxifen, tricyclic antidepressants (nortriptyline, amitriptyline, imipramine, clomipramine)
* Inability to monitor body temperature (oral, axillary, tympanic or frontal) at least twice a day from study enrollment day (Day 1) to the end of the study (Day 14).
* Inability to provide informed consent to the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04351620
Study Brief:
Protocol Section:
NCT04351620