Clinical trial 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
Official title: COVID-19 Related Outcomes Among Cancer Patients Treated With TKIs, Including RegorafeNib or SorAfenib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Solid Tumors
Coronavirus Disease 2019 (COVID-19)
SARS-CoV-2 Infection
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-10-26
Enrollment: 4103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: All-cause mortality for TKI-treated group and non-TKI-treated group
timeFrame: Retrospective data analysis from October 2019 to June 2021
measure: COVID-19 related hospitalizations for TKI-treated group and non-TKI-treated group
timeFrame: Retrospective data analysis from October 2019 to June 2021
measure: Intensive Care Unit (ICU) admission during COVID-19 related hospitalization for TKI-treated group and non-TKI-treated group
timeFrame: Retrospective data analysis from October 2019 to June 2021
measure: Use of mechanical ventilator during COVID-19 related hospitalization for TKI-treated group and non-TKI-treated group
timeFrame: Retrospective data analysis from October 2019 to June 2021
measure: Emergency room visit with a diagnosis of COVID-19 for TKI-treated group and non-TKI-treated group
timeFrame: Retrospective data analysis from October 2019 to June 2021
measure: Newly diagnosed COVID-19 related complications (not present at baseline) for TKI-treated group and non-TKI-treated group
timeFrame: Retrospective data analysis from October 2019 to June 2021
Secondary outcomes:
measure: All-cause mortality for Regorafenib or Sorafenib treated group and non-TKI-treated group
timeFrame: Retrospective data analysis from October 2019 to June 2021
measure: COVID-19 related hospitalizations for Regorafenib or Sorafenib treated group and non-TKI-treated group
timeFrame: Retrospective data analysis from October 2019 to June 2021
measure: Intensive Care Unit (ICU) admission during COVID-19 related hospitalization Regorafenib or Sorafenib treated group and non-TKI-treated group
timeFrame: Retrospective data analysis from October 2019 to June 2021
measure: Use of mechanical ventilator during COVID-19 related hospitalization Regorafenib or Sorafenib treated group and non-TKI-treated group
timeFrame: Retrospective data analysis from October 2019 to June 2021
measure: Emergency room visit with a diagnosis of COVID-19 Regorafenib or Sorafenib treated group and non-TKI-treated group
timeFrame: Retrospective data analysis from October 2019 to June 2021
measure: Newly diagnosed COVID-19 related complications (not present at baseline) Regorafenib or Sorafenib treated group and non-TKI-treated group
timeFrame: Retrospective data analysis from October 2019 to June 2021
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Bayer
state: New Jersey
Study officials:
References: