This study aims to examine the tolerability of high dose of leflunomide in patients with COVID-19 who are being managed in the outpatient setting.
This is a single are and single-center tolerability study of high dose leflunomide therapy in
outpatient adult participants with mild COVID-19. In vitro studies have shown antiviral
effects of leflunomide against SARS CoV-2, but the clinical outcomes in the disease have been
variable. Our 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 leflunomide in
this setting.
Patients are selected based on identification of mild COVID-19 symptoms. Investigators will
enroll twenty patients and perform a detailed Tele-helath interview to ensure they meet
eligibility criteria and provide informed consent. 100 mg leflunomide daily for three days
followed by 30 mg day will be prescribed. The subjects will be required to monitor their
temperatures twice daily and a daily telephone call with an investigatory will review
symptoms of disease and potential side effects of the drug. Subjects can discontinue the drug
after five days if they no longer have fever, or take the drug for up to ten days if required
for fever resolution.
Drug: Leflunomide
Tolerability study of leflunomide 100 mg administered once daily for 3 days followed by 30 mg administered once daily for the duration of 2 - 7 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
- 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
Exclusion Criteria:
- Participation in any other clinical trial of an experimental agent treatment for
COVID-19
- Current hospitalization
- Known hypersensitivity to leflunomide
- Currently taking methotrexate
- Currently taking terliflunomide
- Known chronic kidney disease, stage 4-5, or receiving dialysis
- History of liver disease
- History of interstitial lung disease
- Pregnancy and lactation - pregnancy test required for females
- 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
Investigator: Michael Millis
mmillis@surgery.bsd.uchicago.edu
Michael Millis, MD
773 702 6319
mmillis@surgery.bsd.uchicago.edu
Laurencia Perea
lperea@surgery.bsd.uchicago.edu
Michael Millis, MD, Principal Investigator
University of Chicago