Leflunomide in Mild COVID-19 Patients

COVID-19 Clinical Trial

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

Status Terminated

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT04361214
• Study type: Interventional
• Source: University of Chicago
• Status: Terminated
• Phase: Phase 1
• Start date: May 5, 2020
• Completion date: January 31, 2022