Leflunomide in Mild COVID-19 Patients

• Status: Recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: University of Chicago
• Treatments: Leflunomide

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

• 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.