CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2 enrolled
Drug / intervention
Leflunomide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04532372
NCT04532372Phase 2Completed

A Phase 1/2 Trial of Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy

City of Hope Medical Center·interventional·Posted Aug 31, 2020·Updated Jul 3, 2024

In Brief

A Phase 2 clinical trial evaluating Best Practice, Leflunomide, and 1 other intervention for Hematopoietic and Lymphoid Cell Neoplasm and 2 related conditions. Completed, enrolled 2 participants across 1 site.

Detailed Summary

This phase I/II trial investigates the best dose and side effects of leflunomide and how well it works in treating patients with COVID-19 and a past or present cancer. Leflunomide has been used since the 1990s as a treatment for rheumatoid arthritis. Experiments done with human cells that were given severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19, showed that leflunomide was able to reduce the ability of the virus to make copies of itself. The coronavirus uses ribonucleic acid (RNA), a very long molecule that contains genetic information that is like a blueprint for making more copies of itself. Leflunomide inhibits the formation of RNA. The information gained from this study may help researchers to learn whether leflunomide is safe for use in treating patients with COVID-19, and whether it is potentially effective against the disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedAug 31, 2020
Enrollment StartJan 7, 2021
Primary CompletionAug 26, 2021
Study CompletionOct 27, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.8 years ago

Interventions

Best Practiceother

Receive standard of care drugs

Leflunomidedrug

Given PO

Placebo Administrationdrug

Given PO