The C3I COVID-19 Project

• ClinicalTrials.gov Identifier: NCT04506528
• Recruitment Status: Recruiting
• First Posted: August 10, 2020
• Last Update Posted: August 12, 2020
• Sponsor: University of Wisconsin, Madison
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

Brief Summary:

This cohort study will obtain electronic health record (EHR) de-identified data from 21 health systems affiliated with the Cancer Center Cessation Initiative (C3I) network or health systems with large numbers of COVID-19 patients to explore whether smoking status, cancer history, and other risk factors among patients diagnosed with COVID-19 are associated with mortality and/or COVID-19 disease severity/complications. Each site will provide de-identified data from their health system EHR on a monthly basis that includes all patients identified as having COVID-19 at some point in the interval from February 1, 2020, through December 31, 2020.

Condition or disease
Covid19; Cancer; Nicotine Dependence; Pulmonary Disease; Cardiovascular Diseases; Immunosuppression Disorders

Detailed Description:

This cohort study will obtain electronic health record (EHR) de-identified data from 21 health systems affiliated with the Cancer Center Cessation Initiative (C3I) network or health systems with large numbers of COVID-19 patients to explore whether smoking status, cancer history, and other risk factors among patients diagnosed with COVID-19 are associated with mortality and/or COVID-19 disease severity/complications. The Cancer Center Cessation Initiative (C3I) is a project launched by the US National Cancer Institute (NCI) to improve the rate at which NCI-designated Cancer Centers provide evidence-based smoking cessation to patients diagnosed with and treated for cancer. The C3I is coordinated at the University of Wisconsin-Center for Tobacco Research and Intervention (UW-CTRI) and the University of Wisconsin Carbone Cancer Center (UWCCC). Twenty-one health systems across the U.S. will provide EHR de-identified data to the UW-CTRI coordinating center on all COVID-19 patients identified during the period from February 1, 2020, through December 31, 2020.

Current EHR-based data elements collected will include:

Evidence of COVID-19: ICD-10-CM diagnosis of COVID-19, COVID-19 PCR lab test, and/or COVID-19 antibody lab test

Healthcare system encounter type: inpatient, outpatient, emergency department (ED), urgent care, or other

SES/Demographics variables: insurance status, education, housing status, sex, age, race/ethnicity, height, weight, body mass index

Comorbid diseases: chronic asthma, chronic COPD, chronic bronchiectasis, diabetes mellitus, cardiovascular disease, chronic renal disease, on dialysis, immunocompromised [due to SLE lupus, rheumatoid arthritis, organ transplant, HIV, Crohns], pregnant, cancer (lymphomas, leukemias, lung/respiratory, rectal, breast, prostate, pancreas), hypertension, depression, anxiety, alcohol abuse, pro- clotting disorders, and anti-clotting disorders

Tobacco use variables: smoking status (current, former, never), passive smoke exposure for never smoker, years since quitting (for former smokers), packs smoked per day, years of smoking, pack years, smokeless tobacco user, and marijuana use

Radiographic tests: chest CTs/MRIs, head CTs/MRIs, abdominal CTs/MRIs, lower extremities ultrasound, and cardiac echo

Signs and symptoms: temperature, pulse, systolic blood pressure, diastolic blood pressure, oxygen saturation, septic shock, pneumonia, chills, muscle aches/myalgia, rhinorrhea, sore throat, chronic cough, shortness of breath, nausea or vomiting, headache, abdominal pain, diarrhea, dizziness, impaired consciousness, acute cerebrovascular event, ataxia, seizure, taste impairment, smell impairment, vision impairment, nerve pain, and skeletal muscular pain

COVID-19 treatment variables: ICU admission, required supplemental oxygen, intubated for ventilator use, noninvasive positive pressure, and number of days hospitalized COVID-19 medications: chloroquine, hydroxychloroquine, tocilizumab, remdesivir, dexamethasone, convalescent plasma, and ascorbic acid

Classes of other medications used: nicotine replacement therapies (NRTs), varenicline medications; blood thinners, steroids, angiotensin converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), short-acting adrenergic bronchodilators, long-acting adrenergic bronchodilators, anticholinergic bronchodilators, bronchodilators combos, inhaled corticosteroids (includes combo medications), and inhaled corticosteroid bronchodilators

Lab tests: CBC, hematology (e.g., neutrophils, lymphocytes, hemoglobin, hematocrit), chemistry (e.g., potassium, BUN, creatinine, glucose), liver function tests, coagulation (INR, D-dimer), inflammatory markers (e.g., ESR, IL-6, C-reactive protein), troponin, Hemoglobin A1C, and tests for various infections

NOTE: As the COVID-19 pandemic evolves and additional relevant EHR variables are identified (e.g., convalescent plasma), they will be added to the list of variables collected.

For the initial paper(s) to be prepared based on these data, the main analytic methods will include GUIDE classification and regression tree models. However, whole sample methods will also be used as complementary analytic methods, which will vary with regard to outcome type: i.e., logistic regression for binary outcomes and Cox proportional hazard analyses for time-to-event outcomes. Initial analyses will focus on hospitalized COVID-19 patients. Later waves of analyses may use different analytic approaches and address different questions. These will be described in subsequent CT.gov filings.

Participating healthcare systems:

• Duke University (Duke Health)
• Hackensack Meridian Health
• Mayo Clinic
• Memorial Sloan Kettering Cancer Center
• University of Michigan (Michigan Medicine)
• Mount Sinai Health System
• Northwestern University
• New York University (NYU Langone Health)
• University of California Davis (University of California Davis Comprehensive Cancer Center / UC Davis Health)
• University of California San Francisco
• University of North Carolina at Chapel Hill (UNC Health)
• University of Chicago
• University of Illinois at Chicago
• University of Kansas (University of Kansas Medical Center)
• University of Maryland
• University of Utah (University of Utah Health)
• University of Wisconsin (UW Health)
• Vanderbilt University (Vanderbilt University Medical Center)
• Virginia Commonwealth University (VCU Health System/Massey Cancer Center)
• Washington University St Louis
• Yale University (Yale New Haven Hospital)

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 170000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Target Follow-Up Duration: 10 Months
• Official Title: Investigating the Association Between Smoking Status and COVID-19 Outcomes: Collecting Data From Health Systems Affiliated With the National Cancer Institute's Cancer Center Cessation Initiative (C3I)
• Actual Study Start Date: August 10, 2020
• Estimated Primary Completion Date: January 31, 2021
• Estimated Study Completion Date: December 31, 2021

Groups and Cohorts

Group/Cohort
Patients with COVID-19; The cohort analyzed for the first paper will be those who have met COVID-19 criteria and who have been hospitalized. COVID-19 criteria for inclusion in the study include: ICD-10-CM diagnosis of COVID-19, COVID-19 PCR lab test, and/or COVID-19 antibody lab test.

Outcome Measures

Primary Outcome Measures :

1. Mortality due to COVID-19 [ Time Frame: February 1, 2020, through December 31, 2020 ]
   Death resulting from COVID-19 illness in inpatients vs discharge from hospital (binary outcome)
2. COVID-19 Severity [ Time Frame: February 1, 2020, through December 31, 2020 ]
   COVID-19 severity as measured by intubation for respiratory support (i.e., patient required intubation during hospitalization) - binary variable

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

All patients with COVID-19 in the 21 participating healthcare systems

Criteria

Inclusion Criteria:

• COVID-19 positive PCR test
• a COVID-19 ICD-10-CM diagnosis code during a healthcare visit, or a COVID-19 positive antibody test
• Must be a patient in one of the 21 participating healthcare systems

Exclusion Criteria:

• N/A

Contacts and Locations

Contacts

Contact: Stevens S Smith, PhD; 6082627563; sss@ctri.wisc.edu

Contact: Tanya R Schlam, PhD; 6082624149; trschlam@ctri.wisc.edu

Locations

United States, Wisconsin

University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention; Recruiting

Madison, Wisconsin, United States, 53711

Contact: Amy Conlon, MPH 608-265-4563 aconlon@ctri.wisc.edu

Contact: Stevens S Smith, PhD 608-262-7563 ext Smith sss@ctri.wisc.edu

Principal Investigator: Michael C Fiore, MD, MPH, MBA

Sponsors and Collaborators

University of Wisconsin, Madison

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Betsy Rolland, PhD, MLIS, MPH; University of Wisconsin, Madison
• Principal Investigator: Michael C Fiore, MD, MPH, MBA; University of Wisconsin Center for Tobacco Research and Intervention
• Study Director: Rob Adsit, MEd; University of Wisconsin Center for Tobacco Research and Intervention

More Information

Publications:

Loh, W.-Y. (2002). Regression trees with unbiased variable selection and interaction detection. Stat. Sinica, 12:361-386.

Loh, W.-Y. (2011). Classification and regression trees. WIRES Data Min. Knowl., 1:14-23.

Loh WY, Man M, Wang S. Subgroups from regression trees with adjustment for prognostic effects and postselection inference. Stat Med. 2019 Feb 20;38(4):545-557. doi: 10.1002/sim.7677. Epub 2018 Apr 19.

Loh, W.-Y. and Zhou, P. (2020). The GUIDE approach to subgroup identification. In Ting, N., Cappelleri, J. C., Ho, S., and Chen, D.-G., editors, Design and analysis of Subgroups with Biopharmaceutical Applications, pages 147-165. Springer.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT04506528
• Other Study ID Numbers: 2020-069; OISE-20-66590-1 ( Other Grant/Funding Number: National Cancer Institute (CRDF Contract) ); A534253 ( Other Identifier: UW Madison ); SMPH/MEDICINE ( Other Identifier: UW Madison ); CTRI ( Other Identifier: UW Madison )
• First Posted: August 10, 2020
• Last Update Posted: August 12, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The investigators anticipate that the full de-identified data set will be secured, cleaned, harmonized, and undergo initial analyses through early 2021.The existing Data Transfer and Use Agreements (DTUA) negotiated with each 21 participating health systems precludes the University of Wisconsin (UW) from sharing these data with any entity at this time. This was a requirement of the UW IRB prior to transferring the de-identified site data sets to UW. Thus, until 2021, data will not be distributed outside of the University of Wisconsin. However renegotiation of the DTUAs between the 21 health systems and the University of Wisconsin is anticipated during 2021. The goal is that by the fourth quarter of 2021, UW will have obtained permission to share the de-identified data sets from all of the participating health systems, placing the complete data set in a secure location consistent with HIPAA and IRB requirements, so that other investigators can analyze and use the data.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code
• Time Frame: Data will be available in the fourth quarter of 2021; no decision yet on how long data will be available but likely multiple years.
• Access Criteria: Scientists at the 21 participating healthcare systems will be given priority in terms of access to study data; data sharing with other scientists not affiliated with the 21 participating healthcare systems will be determined in consultation with the study funder (National Cancer Institute).

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wisconsin, Madison:

COVID-19

Additional relevant MeSH terms:

Cardiovascular Diseases; Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders