check_circleStudy Completed

Malignant solid tumors, Coronavirus disease 2019 (COVID-19), SARS-CoV-2 Infection

Bayer Identifier:

22294

ClinicalTrials.gov Identifier:

NCT05594147

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • 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

    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
  • 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 summary

Enrollment Goal
4103
Trial Dates
October 2022 - April 2023
Phase
N/A
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
BayerWhippany, 07981, United States

Primary Outcome

  • All-cause mortality for TKI-treated group and non-TKI-treated group
    This analysis will use subjects from Optum only.
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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: a. Pneumonia b. Multisystem inflammatory syndrome c. Acute hepatic failure d. Acute kidney failure e. Acute myocarditis f. Acute respiratory distress syndrome g. Cardia arrhythmia h. Sepsis i. Viral cardiomyopathy j. Viral pericarditis
    date_rangeTime Frame:
    Retrospective data analysis from October 2019 to June 2021

Secondary Outcome

  • All-cause mortality for Regorafenib or Sorafenib treated group and non-TKI-treated group
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime Frame:
    Retrospective data analysis from October 2019 to June 2021

Trial design

COVID-19 Related Outcomes among Cancer Patients Treated with TKIs, including RegorafeNib or SorAfenib
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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