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.
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 SARS Cov-2, but the clinical outcomes in the disease have been
variable. The hypothesis is that targeting high risk patients earlier in the disease course
and with a higher dose regimen are both required to see improvement in disease outcome
measures in COVID-19. This study aims to prove the tolerability of high dose HCQ in this
setting.
Patients are selected based on the identification of risk factors associated with more severe
disease outcomes. Investigators will enroll twenty patients and perform a detailed
Tele-health interview to ensure they meet eligibility criteria and provide informed consent.
1200 mg hydroxychloroquine daily will be prescribed, in divided doses.The subjects will be
required to monitor their temperatures twice daily and a daily telephone call with an
investigator will review symptoms of disease and potential side effects of the drug. Subjects
can discontinue the medication after five days if they no longer have fever, or take the
medication for up to ten days if required for fever resolution.
Drug: Hydroxychloroquine
Tolerability study of HCQ 1200 mg administered daily in divided doses for a duration of 5-10 days
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.
University of Chicago
Chicago, Illinois, United States
Reem Jan, Principal Investigator
University of Chicago