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

Study Overview
=================
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.

Official Title
-----------------
COVID-19 Related Outcomes Among Cancer Patients Treated With TKIs, Including RegorafeNib or SorAfenib

Conditions
-----------------
Malignant Solid Tumors, Coronavirus Disease 2019 (COVID-19), SARS-CoV-2 Infection

Intervention / Treatment
-----------------
* Drug: Non-TKIs
* Drug: Other TKIs
* Drug: Regorafenib (Stivarga, BAY73- 4506)
* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TKIs treated group<br>Adult cancer patients with newly diagnosed COVID-19 who used Tyrosine kinase inhibitors (TKIs) within 30 days before COVID-19 diagnosis. | Drug: Other TKIs<br>* Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.<br>Drug: Regorafenib (Stivarga, BAY73- 4506)<br>* Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.<br>Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.<br>|
| Non-TKIs treated group<br>Adult cancer patients with newly diagnosed COVID-19 who used other anti-cancer therapies 30 days before COVID-19 diagnosis | Drug: Non-TKIs<br>* Retrospective cohort analysis, using IBM MarketScan and Optum Clinformatics database in the US.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality for Regorafenib or Sorafenib treated group and non-TKI-treated group |  | Retrospective data analysis from October 2019 to June 2021 | 
| COVID-19 related hospitalizations for Regorafenib or Sorafenib treated group and non-TKI-treated group |  | 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 |  | 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 |  | 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 |  | 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 |  | Retrospective data analysis from October 2019 to June 2021 |