Status:
TERMINATED
Leflunomide in Mild COVID-19 Patients
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 of leflunomide in patients with COVID-19 who are being managed in the outpatient setting.
Detailed Description
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 lefluno...
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
- 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
- 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.
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04361214
Start Date
May 5 2020
End Date
January 31 2022
Last Update
February 7 2024
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637