Dasatinib Anhydrous for COVID-19

Phase-Based Estimates
1
Effectiveness
2
Safety
USC / Norris Comprehensive Cancer Center, Los Angeles, CA
COVID-19+2 More
Dasatinib Anhydrous - Drug
Eligibility
18+
All Sexes
Eligible conditions
COVID-19

Study Summary

This study is evaluating whether dasatinib may help reduce inflammation caused by COVID-19.

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Eligible Conditions

  • COVID-19
  • Laboratory Infection
  • Symptomatic COVID-19 Infection Laboratory-Confirmed

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Dasatinib Anhydrous will improve 1 primary outcome and 7 secondary outcomes in patients with COVID-19. Measurement will happen over the course of Up to 28 days.

Month 1
Radiological response
Month 1
Absolute lymphocyte count
CRP (C-reactive protein) level
Change of the SOFA (Sequential Organ Failure Assessment)
Day 30
Number of participants with treatment-related side effects
Month 1
Duration of hospitalization
Up to 1 month
Remission of respiratory symptoms
Up to 28 days
Proportion of participants requiring invasive mechanical ventilation, requiring tocilizumab or dying

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Arm II (placebo administration)
Arm I (dasatinib anhydrous)
Placebo group

This trial requires 144 total participants across 2 different treatment groups

This trial involves 2 different treatments. Dasatinib Anhydrous is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm I (dasatinib anhydrous)
Drug
Patients receive dasatinib anhydrous PO QD for 14 days in the absence of disease progression or unacceptable toxicity.
Arm II (placebo administration)
Drug
Patients receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 month
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 1 month for reporting.

Closest Location

USC / Norris Comprehensive Cancer Center - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A patient with moderate disease has a peripheral capillary oxygen saturation (SpO2) of >= 93% on room air and 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 show original
This person's blood oxygen saturation level is below 93% when breathing room air. show original
The partial pressure of oxygen measurement is less than or equal to 300 mmHg. show original
prior to admission or detection of Sars-CoV2 antigen in respiratory secretions Patients must have laboratory test proven COVID19 infection and symptomatic disease requiring hospitalization: virological diagnosis of Sars-CoV2 infection (polymerase chain reaction [PCR]) within 14 days prior to admission or detection of Sars-CoV2 antigen in respiratory secretions. show original
The subject is able to sign an informed consent form for their participation in the study. show original
A blood test showed that the person's absolute neutrophil count was more than 1000. show original
If a person's respiratory rate is 30 breaths per minute or more, then they should seek medical attention. show original
A person has a blood count of 50,000 platelets per millimeter cubed. show original
Alanine aminotransferase and aspartate aminotransferase levels that are below 5 times the upper limit of what is considered normal indicate a low likelihood of liver damage. show original
The total bilirubin level is less than three times the institutional upper limit of normal. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is dasatinib anhydrous typically used in combination with any other treatments?

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There are limited evidence-based treatments for coronavirus infection; however, dasatinib is likely to have potential to be combined with at least three other agents, and more evidence is required for some of these combinations.

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Can covid-19 be cured?

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We cannot prove at the present stage any evidence that covid-19 can be cured. The evidence on the other hand is accumulating in favor of a correlation between the virus's replication and clinical disease pathogenesis.

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What is covid-19?

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As recently as 2015, the virus was thought to only be a minor problem due to a very low case-fatality rate; however, the pandemic strain, SARS-CoV-2, caused a large number of deaths during that period, making the disease more lethal, especially when the disease is transmitted from person to person through close and prolonged contact with other infected individuals.

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What is the average age someone gets covid-19?

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The world is disproportionately affected by the virus, and the numbers who develop it are increasing daily. The WHO is conducting epidemiological studies of [covid-19] cases all across the world and the average age of people with the virus have been published every day in the [power(http://www.withpower.com/) website.

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What are the signs of covid-19?

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A cough which does not clear up in 24 to 72 hours is most likely to be due to COD and should be investigated for the presence of a potential COVID-19 infection (symptomatic COVID-19 infection). In those with signs of respiratory illness or fever and no respiratory symptoms, a lager sternal breath sound (possibly due to a laryngeal/tracheal infection) is a hallmark that warrants COD investigation/testing. A high or rising neutrophilia (> or = 16%) or lymphopenia (> or = 18%) also warrants testing for potential COVID-19 infection.

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What are common treatments for covid-19?

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Common treatments for the covid-19 virus are hydration, corticosteroids, antipyretics, and analgesics, and antibiotics. Some studies suggest an antibody therapy exists for the virus. However, while supportive therapy may be used along with anti-viral drug therapy to decrease the likelihood of death, mortality is extremely high. Vaccines are in development to hopefully prevent the virus. There is still, however, no cure for the virus.

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What causes covid-19?

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The causative virus in the 2019 crisis can be readily isolated. Some viral transmission between people is likely to occur, and the virus may circulate in the community for long periods with minimal symptoms before onset, but is likely to be transmitted within households with symptomatic sufferers, as well as within countries, either by tourists or returnees from those countries.

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How many people get covid-19 a year in the United States?

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About 1% of all adults will contract the virus. Most of all, the rate will be higher in the US than the rest of the world. And, a higher percentage than estimated in other surveys may arise when considering the impact of the virus on a healthy population. This data will be helpful to help formulate a plan for treatment and public health actions. And, the data is a reference for the world, on how many will get the disease and when.

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Does dasatinib anhydrous improve quality of life for those with covid-19?

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Dasatinib anhydrous did not reduce the number of symptoms of influenza, but it was effective in reducing symptoms of COVID-19. For patients who are treated with dasatinib, there was a substantial reduction in disease severity and a moderate improvement in illness duration.

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How serious can covid-19 be?

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There is a significant correlation between the risk of death and the severity of the disease. Data from a recent study has shown that the severity of the disease is associated with increased duration of the illness, which is in turn associated with an increased risk of death. Thus, assessing the severity of the disease at admission helps to assess the prognosis and provides important clinical guidance to the attending physicians.

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What are the common side effects of dasatinib anhydrous?

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Dasatinib is generally well tolerated. Mild-to-moderate rash (mostly in the face/neck in 10% to 15% of patients) was the most common side effect. It was transient in most cases and in half of cases could be treated with simple moisturizers. Severe rash (scalp necrosis and/or blistering) occurred in only one patient in clinical practice and two patients in clinical trial. In patients, the treatment with dasatinib is often discontinued due to such severe side effects. However, several case reports of complete resolution of these side effects after discontinuation of treatment with dasatinib have been reported. Drug interactions with dasatinib were only reported in one case.

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Have there been other clinical trials involving dasatinib anhydrous?

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The clinical trial for CSD, while not fully completed, showed a significant correlation between high plasma levels of DAS-dT and a reduced efficacy. The clinical trial for CSD was terminated on December 23, 2019.

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