Leflunomide in Mild COVID-19 Patients

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04361214
• Other study ID #: IRB20-0622
• Status: Terminated
• Phase: Phase 1
• Start date: May 5, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of high dose leflunomide as measured by leflunomide dose modifications	Number of subjects requiring leflunomide dose modifications	14 days
Primary	Tolerability of high dose leflunomide as measured by discontinuation of leflunomide	Number of subjects that discontinue leflunomide	14 days
Primary	Tolerability of high dose leflunomide as measured by Adverse Events	Number of Adverse Events observed in all subjects for the duration of the study	14 days
Secondary	Time to defervescence as measured in days while on treatment protocol	The number of days to reach first fever normalization (criteria for normalization: temperature < 100.4 F)	14 days
Secondary	Resolution of other COVID-19 symptoms measured in days while on treatment protocol	Number of days to resolve other symptoms, as assessed by a standardized questionnaire for symptom assessment	14 days