Leflunomide in Mild COVID-19 Patients

NCT04361214 | Terminated Phase 1 FDA Drug

• 1 other identifier: IRB20-0622
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

leflunomide

Outcome Measures

Primary Outcomes (3)

• Tolerability of high dose leflunomide as measured by leflunomide dose modifications

  Number of subjects requiring leflunomide dose modifications

  14 days

• Tolerability of high dose leflunomide as measured by discontinuation of leflunomide

  Number of subjects that discontinue leflunomide

  14 days

• 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 Outcomes (2)

• Time to defervescence as measured in days while on treatment protocol

  14 days

• Resolution of other COVID-19 symptoms measured in days while on treatment protocol

  14 days

Study Arms (1)

Leflunomide

EXPERIMENTAL

Leflunomide 300 mg once daily administered for three days followed by 30 mg once daily administered for two days or until fevers abate (maximum ten days of treatment allowed). If patients report symptoms attributed to the medication, the dose will be administered at 50 mg once daily for the loading dose followed by 20 mg once daily.

Drug: Leflunomide

Interventions

Leflunomide DRUG

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.

Leflunomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Leflunomide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael Millis, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: May 5, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)