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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05594147
Other study ID # 22294
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 31, 2022
Est. completion date April 21, 2023

Study information

Verified date November 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 4103
Est. completion date April 21, 2023
Est. primary completion date April 21, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States Bayer Whippany New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality for TKI-treated group and non-TKI-treated group This analysis will use subjects from Optum only. Retrospective data analysis from October 2019 to June 2021
Primary COVID-19 related hospitalizations for TKI-treated group and non-TKI-treated group Any inpatient visit with a diagnosis of COVID-19 Retrospective data analysis from October 2019 to June 2021
Primary Intensive Care Unit (ICU) admission during COVID-19 related hospitalization for TKI-treated group and non-TKI-treated group Retrospective data analysis from October 2019 to June 2021
Primary Use of mechanical ventilator during COVID-19 related hospitalization for TKI-treated group and non-TKI-treated group Retrospective data analysis from October 2019 to June 2021
Primary Emergency room visit with a diagnosis of COVID-19 for TKI-treated group and non-TKI-treated group Retrospective data analysis from October 2019 to June 2021
Primary Newly diagnosed COVID-19 related complications (not present at baseline) for TKI-treated group and non-TKI-treated group Complications Including:
Pneumonia
Multisystem inflammatory syndrome
Acute hepatic failure
Acute kidney failure
Acute myocarditis
Acute respiratory distress syndrome
Cardia arrhythmia
Sepsis
Viral cardiomyopathy
Viral pericarditis
Retrospective data analysis from October 2019 to June 2021
Secondary All-cause mortality for Regorafenib or Sorafenib treated group and non-TKI-treated group Retrospective data analysis from October 2019 to June 2021
Secondary COVID-19 related hospitalizations for Regorafenib or Sorafenib treated group and non-TKI-treated group Retrospective data analysis from October 2019 to June 2021
Secondary Intensive Care Unit (ICU) admission during COVID-19 related hospitalization Regorafenib or Sorafenib treated group and non-TKI-treated group Retrospective data analysis from October 2019 to June 2021
Secondary Use of mechanical ventilator during COVID-19 related hospitalization Regorafenib or Sorafenib treated group and non-TKI-treated group Retrospective data analysis from October 2019 to June 2021
Secondary Emergency room visit with a diagnosis of COVID-19 Regorafenib or Sorafenib treated group and non-TKI-treated group Retrospective data analysis from October 2019 to June 2021
Secondary Newly diagnosed COVID-19 related complications (not present at baseline) Regorafenib or Sorafenib treated group and non-TKI-treated group Retrospective data analysis from October 2019 to June 2021
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