Clinical trial NCT04361214: Leflunomide in Mild COVID-19 Patients
Official title: Leflunomide for the Treatment of Ambulatory Patients With Mild COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: COVID-19
Keywords: leflunomide
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Tolerability of high dose leflunomide as measured by leflunomide dose modifications
timeFrame: 14 days
measure: Tolerability of high dose leflunomide as measured by discontinuation of leflunomide
timeFrame: 14 days
measure: Tolerability of high dose leflunomide as measured by Adverse Events
timeFrame: 14 days
Secondary outcomes:
measure: Time to defervescence as measured in days while on treatment protocol
timeFrame: 14 days
measure: Resolution of other COVID-19 symptoms measured in days while on treatment protocol
timeFrame: 14 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Michael Millis, MD
role: PRINCIPAL_INVESTIGATOR
References: