Leflunomide in Mild COVID-19 Patients
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|ClinicalTrials.gov Identifier: NCT04361214|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Leflunomide||Phase 1|
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 risk factors associated with more severe disease outcomes. 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Leflunomide for the Treatment of Ambulatory Patients With Mild COVID-19|
|Actual Study Start Date :||May 5, 2020|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
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.
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.
- Tolerability of high dose leflunomide as measured by leflunomide dose modifications [ Time Frame: 14 days ]Number of subjects requiring leflunomide dose modifications
- Tolerability of high dose leflunomide as measured by discontinuation of leflunomide [ Time Frame: 14 days ]Number of subjects that discontinue leflunomide
- Tolerability of high dose leflunomide as measured by Adverse Events [ Time Frame: 14 days ]Number of Adverse Events observed in all subjects for the duration of the study
- Rate of hospitalization due to COVID-19 as measured by number of patients hospitalized [ Time Frame: 14 days ]Number of patients admitted to hospital during study period
- Time to defervescence as measured in days while on treatment protocol [ Time Frame: 14 days ]The number of days to reach first fever normalization (criteria for normalization: temperature < 100.4 F)
- Resolution of other COVID-19 symptoms measured in days while on treatment protocol [ Time Frame: 14 days ]Number of days to resolve other symptoms, as assessed by a standardized questionnaire for symptom assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361214
|Contact: Michael Millis, MD||773 702 email@example.com|
|Contact: Laurencia Pereafirstname.lastname@example.org|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Michael Millis email@example.com|
|Principal Investigator:||Michael Millis, MD||University of Chicago|