High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19

• Status: Recruiting
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Hydroxychloroquine

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.