Trial · NCT04532372

Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy

NCT04532372, Phase 1, Phase 2, Completed, City of Hope Medical Center; results first posted 2024-07-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy. Trials, record NCT04532372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04532372

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Leflunomide for the Treatment of Severe COVID-19 in Patients With a Concurrent Malignancy
NCT number: NCT04532372
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 2 participants, actual
Lead sponsor: City of Hope Medical Center
Conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic COVID-19 Infection Laboratory-Confirmed
Interventions: Best Practice, Leflunomide, Placebo Administration
First posted: 2020-08-31
Last updated: 2024-07-03
Results first posted: 2024-07-03

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose (MTD) (Phase 1)	From the initial study treatment (Day 0) to Day 28.	MTD were based on the assessment of DLT (Dose Limiting Toxicity) during the 28-day treatment period.
Primary	Clinical Activity (Response)(Phase 2)	At day 28	Defined as a \>= 2-point change in clinical status from day 1 on a 7-point ordinal scale. The ordinal scale is an assessment of the clinical status at a given study day. Each day, the worst (i.e., lowest ordinal) score from the previous day was recorded.
Secondary	Time to Clinical Activity (Response)	Up to 28 days	Defined as time from start of treatment to \>= 2-point change in clinical status on a 7-point ordinal scale. The ordinal scale is an assessment of the clinical status at a given study day. Each day, the worst (i.e., lowest ordinal) score from the previous day was recorded.
Secondary	Overall Survival (Phase 2)	Up to 90 days	Defined as time from start of treatment to death from any cause
Secondary	Oxygen Saturation Improvement	Up to 90 days	Time from start of treatment to peripheral capillary oxygen saturation (SpO2) \> 93% on room air.
Secondary	Number of Participants Who Were Hospitalized	Up to 90 days	Indicate the participants who were hospitalized within first 90 days following start of treatment assessed.
Secondary	Number of Participants Who Were Mechanical Ventilation Required	Up to 90 days	Indication the participants who were required mechanical ventilation at any time from start of treatment through 90 days post.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Tolerated Dose (MTD) (Phase 1)	From the initial study treatment (Day 0) to Day 28.	Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I.	mg	NUMBER
PRIMARY	Clinical Activity (Response)(Phase 2)	At day 28	Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I. Therefore, there is no accrual in Phase II.
SECONDARY	Time to Clinical Activity (Response)	Up to 28 days	Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I. Therefore, there is no accrual in Phase II.	days	MEDIAN
SECONDARY	Overall Survival (Phase 2)	Up to 90 days	Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I. Therefore, there is no accrual in Phase II.
SECONDARY	Oxygen Saturation Improvement	Up to 90 days	Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I. Therefore, there is no accrual in Phase II.	days	MEDIAN
SECONDARY	Number of Participants Who Were Hospitalized	Up to 90 days	Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I. Therefore, there is no accrual in Phase II.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Were Mechanical Ventilation Required	Up to 90 days	Due to the low accrual rate, the study was terminated after two subjects enrolled in Phase I. Therefore, there is no accrual in Phase II.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Tolerated Dose (MTD) (Phase 1)	Phase I (Leflunomide, SOC)	NA		mg
Time to Clinical Activity (Response)	Phase I (Leflunomide, SOC)	9.5	Full Range 5 to 14	days
Oxygen Saturation Improvement	Phase I (Leflunomide, SOC)	6.5	Full Range 1 to 12	days
Number of Participants Who Were Hospitalized	Phase I (Leflunomide, SOC)	2		Participants
Number of Participants Who Were Mechanical Ventilation Required	Phase I (Leflunomide, SOC)	0		Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase I (Leflunomide, SOC)	2
Overall Study	STARTED	Phase II Arm I (Leflunomide, SOC)	0
Overall Study	STARTED	Phase II Arm II (Placebo, SOC)	0
Overall Study	COMPLETED	Phase I (Leflunomide, SOC)	2
Overall Study	COMPLETED	Phase II Arm I (Leflunomide, SOC)	0
Overall Study	COMPLETED	Phase II Arm II (Placebo, SOC)	0
Overall Study	NOT COMPLETED	Phase I (Leflunomide, SOC)	0
Overall Study	NOT COMPLETED	Phase II Arm I (Leflunomide, SOC)	0
Overall Study	NOT COMPLETED	Phase II Arm II (Placebo, SOC)	0

Source ClinicalTrials.gov

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ANEMIA	Blood and lymphatic system disorders	Phase I (Leflunomide, SOC)	2	2	2
other	CONSTIPATION	Gastrointestinal disorders	Phase I (Leflunomide, SOC)	1	2	1
other	DYSPHAGIA	Gastrointestinal disorders	Phase I (Leflunomide, SOC)	1	2	1
other	FATIGUE	General disorders	Phase I (Leflunomide, SOC)	1	2	1
other	FEVER	General disorders	Phase I (Leflunomide, SOC)	1	2	1
other	GENERALIZED EDEMA	General disorders	Phase I (Leflunomide, SOC)	1	2	1
other	NON-CARDIAC CHEST PAIN	General disorders	Phase I (Leflunomide, SOC)	1	2	1
other	COVID-19	Infections and infestations	Phase I (Leflunomide, SOC)	2	2	2
other	ALANINE AMINOTRANSFERASE INCREASED	Investigations	Phase I (Leflunomide, SOC)	1	2	2
other	ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	Phase I (Leflunomide, SOC)	1	2	2

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I (Leflunomide, SOC)	0	2
Total, other adverse events	Phase I (Leflunomide, SOC)	2	2
Total, serious adverse events	Phase I (Leflunomide, SOC)	0	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA033572	Cancer Center Support Grant	CARPTEN, JOHN D.	BECKMAN RESEARCH INSTITUTE/CITY OF HOPE	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04532372

GET https://conductscience.org/api/trials/v1/NCT04532372/events?page=2

API reference For AI assistants