COVID-19Phase 1NCT04361214
Leflunomide in Mild COVID-19 Patients
A Phase 1 study testing Leflunomide in people with COVID-19, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Leflunomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2020to 31 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leflunomide for the Treatment of Ambulatory Patients With Mild COVID-19
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Leflunomide
- Keywords
- leflunomide
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeflunomideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Leflunomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of high dose leflunomide as measured by leflunomide dose modifications
Number of subjects requiring leflunomide dose modifications
Measured: 14 days
Tolerability of high dose leflunomide as measured by discontinuation of leflunomide
Number of subjects that discontinue leflunomide
Measured: 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
Measured: 14 days
Secondary outcomes (2)
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)
Measured: 14 days
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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start5 May 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Why it stopped: Terminated by PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Millis, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361214
- Sponsor's protocol ID
- IRB20-0622
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2020
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leflunomide for the Treatment of Ambulatory Patients With Mild COVID-19
- ClinicalTrials.gov ID
- NCT04361214
- Acronym / sponsor ID
- IRB20-0622
- Conditions
- COVID-19
- Keywords
- leflunomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by PI
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leflunomide | Experimental | Drug: LeflunomideLeflunomide 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeflunomideTolerability 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. | Drug | Leflunomide |
Primary outcome
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
2 secondary outcomes
Time to defervescence as measured in days while on treatment protocol
Time frame: 14 days
Resolution of other COVID-19 symptoms measured in days while on treatment protocol
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Terminated by PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Millis, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leflunomide in people with COVID-19, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated by PI). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of high dose leflunomide as measured by leflunomide dose modifications (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.