Symptomatic COVID-19 Infection Laboratory-ConfirmedPhase 2NCT04830735
Dasatinib for the Treatment of Moderate and Severe COVID-19
A Phase 2 study testing Dasatinib Anhydrous in people with Symptomatic COVID-19 Infection Laboratory-Confirmed, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic COVID-19 Infection Laboratory-Confirmed
- What is being tested?
- Dasatinib Anhydrous
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2022to 15 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
- Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessment/procedures being conducted
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Phase II Randomized Double-Blind Trial of Dasatinib Modulation of Hyperinflammation in Moderate and Severe Patients With COVID-19
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the proportion of patients requiring intubation/ventilator support, requiring rescue with tocilizumab, or dying.
II. To determine 1 month survival.
SECONDARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Dasatinib Anhydrous, Placebo Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib AnhydrousDrug
Given PO
Placebo AdministrationDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (dasatinib anhydrous) | Experimental | Patients receive dasatinib anhydrous PO QD for 14 days in the absence of disease progression or unacceptable toxicity. Receives: 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. Receives: Drug: Placebo Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days
Secondary outcomes (9)
Absolute lymphocyte count
Assessment via standard blood chemistry and metabolic panel
Measured: Baseline, during treatment (day 1-14) up to 1 month
CRP (C-reactive protein) level
Assessment via standard blood chemistry and metabolic panel
Measured: Baseline, during treatment (day 1-14) up to 1 month
Change of the SOFA (Sequential Organ Failure Assessment)
The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine
Measured: Baseline, during treatment (day 1-14) up to 1 month
Number of participants with treatment-related side effects
Outcome reported as the number of adverse events and serious adverse events that occurred.
Measured: During treatment and up to 30 days after the last treatment dose
Radiological response
Will be evaluated by chest x-ray or pulmonary computed tomography (CT)
Measured: Baseline (optional), after seven days and if clinically indicated(up to 1 month)
Duration of hospitalization
Outcome reported as the duration of hospitalization of patients
Measured: From baseline up to patient's discharge (up to 1 month)
Remission of respiratory symptoms
Time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation.
Measured: Up to 1 month
Remission of respiratory symptoms
Time to definitive extubation calculated from intubation (any time occurred) to extubation in days.
Measured: Up to 1 month
Remission of respiratory symptoms
Time to independence from oxygen therapy in days.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start5 Aug 2022
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2024 (estimated)
Why it stopped: PI decided not to pursue study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic COVID-19 Infection Laboratory-ConfirmedStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ann Mohrbacher, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830735
- Sponsor's protocol ID
- 0S-20-5
- Other IDs
- NCI-2020-04367, 0S-20-5, P30CA014089
- Status last verified
- Aug 2022
- First submitted
- 1 Apr 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Double-Blind Trial of Dasatinib Modulation of Hyperinflammation in Moderate and Severe Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04830735
- Acronym / sponsor ID
- 0S-20-5
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided not to pursue study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the proportion of patients requiring intubation/ventilator support, requiring rescue with tocilizumab, or dying.
II. To determine 1 month survival.
SECONDARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (dasatinib anhydrous) | Experimental | Drug: Dasatinib AnhydrousPatients receive dasatinib anhydrous PO QD for 14 days in the absence of disease progression or unacceptable toxicity. |
| Arm II (placebo administration) | Placebo comparator | Drug: Placebo AdministrationPatients receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- After the first interim analysis, we may allow enrollment of severe disease COVID infected patients if safety and efficacy analysis appears favorable:
- Severe disease:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dasatinib AnhydrousGiven PO | Drug | Arm I (dasatinib anhydrous) |
| Placebo AdministrationGiven PO | Drug | Arm II (placebo administration) |
Primary outcome
Proportion of participants requiring invasive mechanical ventilation, requiring tocilizumab or dying
Time frame: Up to 28 days
Outcome reported as the number of patients requiring mechanical ventilation, requiring tocilizumab or dying.
9 secondary outcomes
Absolute lymphocyte count
Time frame: Baseline, during treatment (day 1-14) up to 1 month
CRP (C-reactive protein) level
Time frame: Baseline, during treatment (day 1-14) up to 1 month
Change of the SOFA (Sequential Organ Failure Assessment)
Time frame: Baseline, during treatment (day 1-14) up to 1 month
Number of participants with treatment-related side effects
Time frame: During treatment and up to 30 days after the last treatment dose
Radiological response
Time frame: Baseline (optional), after seven days and if clinically indicated(up to 1 month)
Duration of hospitalization
Time frame: From baseline up to patient's discharge (up to 1 month)
Remission of respiratory symptoms
Time frame: Up to 1 month
Remission of respiratory symptoms
Time frame: Up to 1 month
Remission of respiratory symptoms
Time frame: Up to 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Mohrbacher, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib Anhydrous in people with Symptomatic COVID-19 Infection Laboratory-Confirmed, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants requiring invasive mechanical ventilation, requiring tocilizumab or dying (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.