Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-28 @ 8:29 AM
Study NCT ID:
NCT04830735
Status:
WITHDRAWN
Last Update Posted:
2022-08-10
First Post:
2021-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dasatinib for the Treatment of Moderate and Severe COVID-19
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
A Phase II Randomized Double-Blind Trial of Dasatinib Modulation of Hyperinflammation in Moderate and Severe Patients With COVID-19
Status:
WITHDRAWN
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI decided not to pursue study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial investigates how well dasatinib works in treating patients with moderate and severe COVID-19. Dasatinib is a drug used to treat chronic leukemia which may help reduce the strong inflammation caused by COVID-19 that can damage the lungs or other organs.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the proportion of patients requiring intubation/ventilator support, requiring rescue with tocilizumab, or dying.
II. To determine 1 month survival.
SECONDARY OBJECTIVES:
I. To estimate the safety and tolerability of dasatinib anhydrous (dasatinib) in the setting of COVID-19 infection.
II. To determine change in C-reactive protein (CRP) levels after starting therapy.
III. To document activity of dasatinib in lessening cytokine release syndrome (CRS) and sequential organ failure assessment (SOFA) score.
EXPLORATORY OBJECTIVES:
I. Interleukin-6 /cytokine assay weekly on treatment protocol. II. Ferritin levels at study entry and every (q) 2 days on treatment protocol. III. D-dimer levels at study entry and q 2 days on treatment protocol.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive dasatinib anhydrous orally (PO) once daily (QD) for 14 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 28 days.
I. To determine the proportion of patients requiring intubation/ventilator support, requiring rescue with tocilizumab, or dying.
II. To determine 1 month survival.
SECONDARY OBJECTIVES:
I. To estimate the safety and tolerability of dasatinib anhydrous (dasatinib) in the setting of COVID-19 infection.
II. To determine change in C-reactive protein (CRP) levels after starting therapy.
III. To document activity of dasatinib in lessening cytokine release syndrome (CRS) and sequential organ failure assessment (SOFA) score.
EXPLORATORY OBJECTIVES:
I. Interleukin-6 /cytokine assay weekly on treatment protocol. II. Ferritin levels at study entry and every (q) 2 days on treatment protocol. III. D-dimer levels at study entry and q 2 days on treatment protocol.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive dasatinib anhydrous orally (PO) once daily (QD) for 14 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 28 days.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-04367 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 0S-20-5 | OTHER | USC / Norris Comprehensive Cancer Center | View | |
| P30CA014089 | NIH | None | https://reporter.nih.gov/quic… | View |