Leflunomide for the Treatment of Ambulatory Patients With Mild COVID-19

IRB20-0622

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.

2020-05-05

2022-01-31

2022-01-31

Terminated

Early phase I

11

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

2024-02-07