Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT04830735
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.
Study:
NCT04830735
Study Brief:
Protocol Section:
NCT04830735