Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830735
Status:
WITHDRAWN
Last Update Posted:
2022-08-10
First Post:
2021-04-01
Brief Title:
Dasatinib for the Treatment of Moderate and Severe COVID-19
Sponsor:
University of Southern California
Organization:
University of Southern California
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WITHDRAWN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 intubationventilator 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 intubationventilator 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-04367 | REGISTRY | None | None |
| 0S-20-5 | OTHER | None | None |
| P30CA014089 | NIH | USC Norris Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA014089 |