NCT05594147

An Observational Study, Called ROCURS, to Learn About COVID-19 Related Outcomes in People With Cancer Who Are Treated With Tyrosine Kinase Inhibitors (TKIs) Including Regorafenib or Sorafenib

COVID-19 Related Outcomes Among Cancer Patients Treated With TKIs, Including RegorafeNib or SorAfenib

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,103 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Malignant Solid Tumors
• Coronavirus Disease 2019 (COVID-19)
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
DRUG	Non-TKIs	Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.
DRUG	Other TKIs	Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.
DRUG	Regorafenib (Stivarga, BAY73- 4506)	Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.
DRUG	Sorafenib (Nexavar, BAY43-9006)	Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.

Timeline

• Start date: 2022-10-31
• Primary completion: 2023-04-21
• Completion: 2023-04-21
• First posted: 2022-10-26
• Last updated: 2023-11-07

Locations

1 site across 1 country: United States