This is an observational study in which data from people with cancer who had the Coronavirus disease 2019 (COVID-19) are collected and studied. In observational studies, only observations are made without specified advice or interventions. The most recently discovered coronavirus (SARS-CoV-2) may cause illness in humans ranging from the common cold to serious illness, also known as COVID-19. People with cancer are particularly at risk of becoming very sick with COVID-19, especially during or shortly after a cancer treatment. Several treatments for COVID-19 have been tested in clinical studies. However, people with cancer or with recent cancer treatments were usually excluded. Tyrosine kinase inhibitors (TKIs) are used to treat several cancer types. TKIs including regorafenib and sorafenib block certain proteins, which are involved in the growth of cancer. They also have an anti-inflammatory effect and may be able to block the entry of the coronavirus into the cell. This could possibly prevent infection. However, data on COVID-19 from people with cancer receiving TKIs are missing. The main purpose of this study is to find out whether COVID-19 outcomes were different in people with cancer receiving TKIs compared to those receiving other anti-cancer drugs. To do this, researchers will compare COVID-19 outcomes within 30 days of COVID-19 diagnosis between both groups. The data for the comparison will come from databases called Optum and MarketScan. Besides this data collection, no further tests or examinations are planned in this study. There are no required visits or tests in this study. Data will be from October 2019 to June 2021 or the latest available data.
Study Type
OBSERVATIONAL
Enrollment
4,103
Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.
Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.
Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.
Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.
Bayer
Whippany, New Jersey, United States
All-cause mortality for TKI-treated group and non-TKI-treated group
This analysis will use subjects from Optum only.
Time frame: Retrospective data analysis from October 2019 to June 2021
COVID-19 related hospitalizations for TKI-treated group and non-TKI-treated group
Any inpatient visit with a diagnosis of COVID-19
Time frame: Retrospective data analysis from October 2019 to June 2021
Intensive Care Unit (ICU) admission during COVID-19 related hospitalization for TKI-treated group and non-TKI-treated group
Time frame: Retrospective data analysis from October 2019 to June 2021
Use of mechanical ventilator during COVID-19 related hospitalization for TKI-treated group and non-TKI-treated group
Time frame: Retrospective data analysis from October 2019 to June 2021
Emergency room visit with a diagnosis of COVID-19 for TKI-treated group and non-TKI-treated group
Time frame: Retrospective data analysis from October 2019 to June 2021
Newly diagnosed COVID-19 related complications (not present at baseline) for TKI-treated group and non-TKI-treated group
Complications Including: 1. Pneumonia 2. Multisystem inflammatory syndrome 3. Acute hepatic failure 4. Acute kidney failure 5. Acute myocarditis 6. Acute respiratory distress syndrome 7. Cardia arrhythmia 8. Sepsis 9. Viral cardiomyopathy 10. Viral pericarditis
Time frame: Retrospective data analysis from October 2019 to June 2021
All-cause mortality for Regorafenib or Sorafenib treated group and non-TKI-treated group
Time frame: Retrospective data analysis from October 2019 to June 2021
COVID-19 related hospitalizations for Regorafenib or Sorafenib treated group and non-TKI-treated group
Time frame: Retrospective data analysis from October 2019 to June 2021
Intensive Care Unit (ICU) admission during COVID-19 related hospitalization Regorafenib or Sorafenib treated group and non-TKI-treated group
Time frame: Retrospective data analysis from October 2019 to June 2021
Use of mechanical ventilator during COVID-19 related hospitalization Regorafenib or Sorafenib treated group and non-TKI-treated group
Time frame: Retrospective data analysis from October 2019 to June 2021
Emergency room visit with a diagnosis of COVID-19 Regorafenib or Sorafenib treated group and non-TKI-treated group
Time frame: Retrospective data analysis from October 2019 to June 2021
Newly diagnosed COVID-19 related complications (not present at baseline) Regorafenib or Sorafenib treated group and non-TKI-treated group
Time frame: Retrospective data analysis from October 2019 to June 2021
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