Dasatinib for the Treatment of Moderate and Severe COVID-19

NCT04830735 | Withdrawn Phase 2 DMC FDA Drug

• 3 other identifiers: 0S-20-5NCI-2020-04367P30CA014089
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic COVID-19 Infection Laboratory-Confirmed

Outcome Measures

Primary Outcomes (1)

• Proportion of participants requiring invasive mechanical ventilation, requiring tocilizumab or dying

  Outcome reported as the number of patients requiring mechanical ventilation, requiring tocilizumab or dying.

  Up to 28 days

Secondary Outcomes (9)

• Absolute lymphocyte count

  Baseline, during treatment (day 1-14) up to 1 month

• CRP (C-reactive protein) level

  Baseline, during treatment (day 1-14) up to 1 month

• Change of the SOFA (Sequential Organ Failure Assessment)

  Baseline, during treatment (day 1-14) up to 1 month

• Number of participants with treatment-related side effects

  During treatment and up to 30 days after the last treatment dose

• Radiological response

  Baseline (optional), after seven days and if clinically indicated(up to 1 month)

Study Arms (2)

Arm I (dasatinib anhydrous)

EXPERIMENTAL

Patients receive dasatinib anhydrous PO QD for 14 days in the absence of disease progression or unacceptable toxicity.

Drug: Dasatinib Anhydrous

Arm II (placebo administration)

PLACEBO COMPARATOR

Patients receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity.

Drug: Placebo Administration

Interventions

Dasatinib Anhydrous DRUG

Given PO

Arm I (dasatinib anhydrous)

Placebo Administration DRUG

Given PO

Arm II (placebo administration)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have laboratory test proven COVID19 and symptomatic disease requiring hospitalization: virological diagnosis of Sars-CoV2 infection (polymerase chain reaction \[PCR\]) within 14 days
• Able to sign informed consent for participation in the study
• Subject is hospitalized with one or more of the following:
• Moderate disease: peripheral capillary oxygen saturation (SpO2) \>= 93% on room air with one of the following risk factors for developing severe disease: age \>= 60 years, history of hypertension, diabetes mellitus, cardiac disease, chronic lung disease, obesity (calculated body mass index \[BMI\] \>= 30 kg/m\^2), and cardiovascular disease, clinical and/or radiological evidence of chest involvement, CRP \> 2X upper limit of normal, doubling of CRP in 24 hours where chest findings and CRP elevation not explained by other underlying disease.
• After the first interim analysis, we may allow enrollment of severe disease COVID infected patients if safety and efficacy analysis appears favorable:
• Severe disease:
• Respiratory rate \>= 30 breaths/ minute (min)
• SpO2 \< 93% while breathing room air
• Partial pressure of oxygen measurement (PaO2)/fraction of inspired oxygen (FiO2) =\< 300 mmHg
• Absolute neutrophil count (ANC) \> 1000 (baseline blood counts)
• Platelets \> 50,000 / mmc (baseline blood counts)
• Alanine aminotransferase/aspartate aminotransferase (ALT/AST) \< 5 times the upper limit of the normality
• Total bilirubin \< 3 x institutional upper limit of normal (IULN)
• Creatinine \< 2.5 times the upper limit of the normality
• Azithromycin allowed but if on both drugs patient should be on constant cardiovascular (CV) monitoring

You may not qualify if:

• Pleural effusion \> grade 2 evident on chest x-ray (CXR) or chest computed tomography (CT)
• Intubation/mechanical ventilation
• Known hypersensitivity to dasatinib
• Patient being treated with immunomodulators or anti-rejection drugs
• Known active infections or other clinical condition that contraindicate dasatinib and cannot be treated or solved according to the judgement of the clinician
• ALT/AST \> 5 times the upper limit of the normality
• Total bilirubin \> 3 x IULN
• Neutrophils \< 1000 / mmc unless; platelets \< 50,000 / mmc

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Study Officials

• Ann Mohrbacher, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: August 5, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2024
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

US (1)