Status:
COMPLETED
High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19
Lead Sponsor:
University of Chicago
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study aims to examine the tolerability of high dose hydroxychloroquine in patients with COVID-19 who are not yet hospitalized, but have risk factors for disease progression and complications.
Detailed Description
This is a single arm and single-center tolerability study of high dose HCQ therapy in outpatient adult participants with mild COVID-19. In vitro studies have shown antiviral effects of HCQ against SAR...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04351620
Start Date
April 20 2020
End Date
June 10 2020
Last Update
February 23 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Chicago
Chicago, Illinois, United States, 60637