Bayer
Whippany, New Jersey, 07981, United States
NCT Number: NCT05594147
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.
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Notify Me18 year and older
All sexes
Observational
Whippany, New Jersey, 07981, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
TKIs Treated Group
Non-TKIs Treated Group
Exclusion criteria
TKIs treated Group
Non-TKIs Treated Group
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.
Time frame: Retrospective data analysis from October 2019 to June 2021
This analysis will use subjects from Optum only.
Time frame: Retrospective data analysis from October 2019 to June 2021
Any inpatient visit with a diagnosis of COVID-19
Time frame: Retrospective data analysis from October 2019 to June 2021
Time frame: Retrospective data analysis from October 2019 to June 2021
Time frame: Retrospective data analysis from October 2019 to June 2021
Time frame: Retrospective data analysis from October 2019 to June 2021
Complications Including:
Time frame: Retrospective data analysis from October 2019 to June 2021
Time frame: Retrospective data analysis from October 2019 to June 2021
Time frame: Retrospective data analysis from October 2019 to June 2021
Time frame: Retrospective data analysis from October 2019 to June 2021
Time frame: Retrospective data analysis from October 2019 to June 2021
Time frame: Retrospective data analysis from October 2019 to June 2021
Bayer
Industry
COVID-19 Related Outcomes Among Cancer Patients Treated With TKIs, Including RegorafeNib or SorAfenib
Acronym: ROCURS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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