AzTrials
AzTrials

Malignant Solid TumorsROCURSNCT05594147

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

An observational study of Malignant Solid Tumors and Coronavirus Disease 2019 (COVID-19), run by Bayer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Non-TKIs, Other TKIs and Regorafenib (Stivarga, BAY73- 4506)
How many people
4,103 participants
Where
1 siteUnited States
Study dates
31 Oct 2022to 21 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult cancer patients with newly diagnosed COVID-19 (the first incidence of COVID-19) who were under TKIs therapy or within 30 days after the last TKIs therapy at the first incidence of COVID-19 from October 1, 2019 to June 30, 2021 or the latest data cut in the databases, will be included in the TKIs treated group. Similarly, newly diagnosed COVID-19 patients who did not receive any TKIs during the same study period will be selected in the non-TKIs treated group.

Who may be able to join

  • TKIs Treated Group
  • Patients ≥18 years old at index date
  • Patients who had any healthcare encounter with a primary or secondary diagnosis of Coronavirus disease 2019 (COVID-19) or positive results from Polymerase Chain Reaction (PCR) lab test for Severe acute respiratory syndrome coronavirus 2 (SARs-CoV-2) during the patient identification period (January 1, 2020 to May 31, 2021 or one month before the latest data cut)
  • Patient who was under TKIs on index date or the last episode of TKIs treatment ended within 30 days before index date
  • Patient who had any diagnosis of solid tumors at any time before index date (identified using ICD-9 or ICD-10 diagnosis codes, Supplementary Table 5)
  • Continuous insurance enrollment for at least 90 days before index date
Show all 12Show fewer
  • Non-TKIs Treated Group
  • Patients ≥18 years old at index date
  • Patients who had any healthcare encounter with a primary or secondary diagnosis of COVID-19 or positive results from PCR lab test for SARs-CoV-2 during the patient identification period
  • Patient who had any diagnosis of solid tumors any time before the index
  • Patient who was under anti-neoplastic medications on index date or the last episode of the anti-neoplastic treatment ended within 30 days before index date
  • Continuous insurance enrollment for at least 90 days before index date

Who cannot join

  • TKIs treated Group
  • Patients who had secondary cancer without site specification (only had ICD-10 codes C79.9 or C80 for metastasis) from 90 days before index
  • Non-TKIs Treated Group
  • Patients who had any claims of TKIs treatment during the study period
  • Patients who had secondary cancer without site specification (only had ICD-10 codes C79.9 or C80 for metastasis) from 90 days before index

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Bayer

    Whippany, New Jersey, 07981

Other trials in United States

About this study

Official title: COVID-19 Related Outcomes Among Cancer Patients Treated With 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 cause illness in humans ranging from the common cold to serious illness, also known as COVID-19.

Read more

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.

Being tested
Non-TKIs, Other TKIs, Regorafenib (Stivarga, BAY73- 4506), Sorafenib (Nexavar, BAY43-9006)
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-TKIsDrug

    Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.

  • Other TKIsDrug

    Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.

  • Regorafenib (Stivarga, BAY73- 4506)Drug

    Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.

  • Sorafenib (Nexavar, BAY43-9006)Drug

    Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.

Study groups in NCT05594147
Study groupRoleWhat they receive
TKIs treated groupAdult cancer patients with newly diagnosed COVID-19 who used Tyrosine kinase inhibitors (TKIs) within 30 days before COVID-19 diagnosis.
Receives: Drug: Other TKIs; Drug: Regorafenib (Stivarga, BAY73- 4506); Drug: Sorafenib (Nexavar, BAY43-9006)
Non-TKIs treated groupAdult cancer patients with newly diagnosed COVID-19 who used other anti-cancer therapies 30 days before COVID-19 diagnosis
Receives: Drug: Non-TKIs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality for TKI-treated group and non-TKI-treated group

    This analysis will use subjects from Optum only.

    Measured: Retrospective data analysis from October 2019 to June 2021

  2. COVID-19 related hospitalizations for TKI-treated group and non-TKI-treated group

    Any inpatient visit with a diagnosis of COVID-19

    Measured: Retrospective data analysis from October 2019 to June 2021

  3. Intensive Care Unit (ICU) admission during COVID-19 related hospitalization for TKI-treated group and non-TKI-treated group

    Measured: Retrospective data analysis from October 2019 to June 2021

  4. Use of mechanical ventilator during COVID-19 related hospitalization for TKI-treated group and non-TKI-treated group

    Measured: Retrospective data analysis from October 2019 to June 2021

  5. Emergency room visit with a diagnosis of COVID-19 for TKI-treated group and non-TKI-treated group

    Measured: Retrospective data analysis from October 2019 to June 2021

  6. 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

    Measured: Retrospective data analysis from October 2019 to June 2021

Secondary outcomes (6)

  1. All-cause mortality for Regorafenib or Sorafenib treated group and non-TKI-treated group

    Measured: Retrospective data analysis from October 2019 to June 2021

  2. COVID-19 related hospitalizations for Regorafenib or Sorafenib treated group and non-TKI-treated group

    Measured: Retrospective data analysis from October 2019 to June 2021

  3. Intensive Care Unit (ICU) admission during COVID-19 related hospitalization Regorafenib or Sorafenib treated group and non-TKI-treated group

    Measured: Retrospective data analysis from October 2019 to June 2021

  4. Use of mechanical ventilator during COVID-19 related hospitalization Regorafenib or Sorafenib treated group and non-TKI-treated group

    Measured: Retrospective data analysis from October 2019 to June 2021

  5. Emergency room visit with a diagnosis of COVID-19 Regorafenib or Sorafenib treated group and non-TKI-treated group

    Measured: Retrospective data analysis from October 2019 to June 2021

  6. Newly diagnosed COVID-19 related complications (not present at baseline) Regorafenib or Sorafenib treated group and non-TKI-treated group

    Measured: Retrospective data analysis from October 2019 to June 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2022
  2. Study start31 Oct 2022
  3. Primary completion21 Apr 2023
  4. Study completion21 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
4,103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05594147
Sponsor's protocol ID
22294
Acronym
ROCURS
Status last verified
Nov 2023
First submitted
21 Oct 2022
Last updated
7 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Questions about this trial

What is this clinical trial studying?

An observational study of Malignant Solid Tumors and Coronavirus Disease 2019 (COVID-19), run by Bayer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality for TKI-treated group and non-TKI-treated group (time frame: Retrospective data analysis from October 2019 to June 2021). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05594147.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in