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NCT05594147 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 4,103
- Enrollment target
NCT05594147: Completed study, sponsored by Bayer.
NCT05594147 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 4,103 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05594147 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 4,103 participants
- Enrollment target
Study 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.
Primary Outcome
This analysis will use subjects from Optum only.
Interventions
- DRUG Sorafenib (Nexavar, BAY43-9006)
- DRUG Non-TKIs
- DRUG Other TKIs
- DRUG Regorafenib (Stivarga, BAY73- 4506)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,103 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2023-04-21 |
What the finished NCT05594147 record still lists
NCT05594147 is an observational study that tracks outcomes without assigning an intervention. Its 4,103 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 4 interventions - of which Sorafenib (Nexavar, BAY43-9006) is the first listed.
NCT05594147 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05594147 about?
NCT05594147 is a clinical study titled "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". 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 c...
What is the current status of trial NCT05594147?
This trial is currently completed. The enrollment target is 4,103 participants. The study started on 2022-10-31. Estimated completion is 2023-04-21.
What interventions are being tested in trial NCT05594147?
The interventions under investigation include: Sorafenib (Nexavar, BAY43-9006) (DRUG), Non-TKIs (DRUG), Other TKIs (DRUG), Regorafenib (Stivarga, BAY73- 4506) (DRUG).
Who is sponsoring clinical trial NCT05594147?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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