NCT04506528

Brief Summary

This cohort study will obtain electronic health record (EHR) data (limited data set) 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 data from their health system EHR on a regular basis that includes all patients identified as having COVID-19 at some point in the interval from February 1, 2020, through January 31, 2022.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,634,381

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

August 7, 2020

Last Update Submit

August 30, 2022

Conditions

COVID-19CancerNicotine DependencePulmonary DiseaseCardiovascular DiseasesImmunosuppression Disorders

Keywords

COVID-19CohortMortality

Outcome Measures

Primary Outcomes (2)

  • Mortality due to COVID-19

    In analyses of hospitalized patients, all-cause mortality in patients with COVID-19 illness vs discharge from hospital (binary outcome)

    February 1, 2020, through January 31, 2022

  • COVID-19 Severity

    In analyses of hospitalized patients, COVID-19 severity as measured by intubation for respiratory support (i.e., patient required intubation during hospitalization; binary outcome)

    February 1, 2020, through January 31, 2022

Study Arms (1)

Patients with COVID-19

Analyses of the cohort data will include (1) all patients, or (2) hospitalized patients meeting specific inclusion criteria.

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • COVID-19 ICD-10-CM diagnosis (U07.1 or J12.82) during a healthcare visit and/or
  • COVID-19 positive PCR test and/or
  • COVID-19 positive antigen test

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Madison, Wisconsin, 53711, United States

Location

Related Publications (6)

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 29671896BACKGROUND

  • 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.

    BACKGROUND

  • Nolan MB, Piasecki TM, Smith SS, Baker TB, Fiore MC, Adsit RT, Bolt DM, Conner KL, Bernstein SL, Eng OD, Lazuk D, Gonzalez A, Hayes-Birchler T, Jorenby DE, D'Angelo H, Kirsch JA, Williams BS, Kent S, Kim H, Lubanski SA, Yu M, Suk Y, Cai Y, Kashyap N, Mathew J, McMahan G, Rolland B, Tindle HA, Warren GW, Abu-El-Rub N, An LC, Boyd AD, Brunzell DH, Carrillo VA, Chen LS, Davis JM, Deshmukh VG, Dilip D, Goldstein AO, Ha PK, Iturrate E, Jose T, Khanna N, King A, Klass E, Lui M, Mermelstein RJ, Poon C, Tong E, Wilson KM, Theobald WE, Slutske WS. Relations of Current and Past Cancer with Severe Outcomes among 104,590 Hospitalized COVID-19 Patients: The COVID EHR Cohort at the University of Wisconsin. Cancer Epidemiol Biomarkers Prev. 2023 Jan 9;32(1):12-21. doi: 10.1158/1055-9965.EPI-22-0500.

    PMID: 35965473BACKGROUND

  • Fiore MC, Smith SS, Adsit RT, Bolt DM, Conner KL, Bernstein SL, Eng OD, Lazuk D, Gonzalez A, Jorenby DE, D'Angelo H, Kirsch JA, Williams B, Nolan MB, Hayes-Birchler T, Kent S, Kim H, Piasecki TM, Slutske WS, Lubanski S, Yu M, Suk Y, Cai Y, Kashyap N, Mathew JP, McMahan G, Rolland B, Tindle HA, Warren GW, An LC, Boyd AD, Brunzell DH, Carrillo V, Chen LS, Davis JM, Dilip D, Ellerbeck EF, Iturrate E, Jose T, Khanna N, King A, Klass E, Newman M, Shoenbill KA, Tong E, Tsoh JY, Wilson KM, Theobald WE, Baker TB. The first 20 months of the COVID-19 pandemic: Mortality, intubation and ICU rates among 104,590 patients hospitalized at 21 United States health systems. PLoS One. 2022 Sep 28;17(9):e0274571. doi: 10.1371/journal.pone.0274571. eCollection 2022.

    PMID: 36170336DERIVED

MeSH Terms

Conditions

COVID-19NeoplasmsTobacco Use DisorderLung DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsRespiratory Tract DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Betsy Rolland, PhD, MLIS, MPH

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

  • Michael C Fiore, MD, MPH, MBA

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

  • Karen L Conner, MPH

    University of Wisconsin, Madison

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 10, 2020

Study Start

June 11, 2020

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

The Limited data set will be secured, cleaned, harmonized, and undergo initial analyses in mid to late 2022.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. Starting in 2023, investigators desiring access to CEC-UW data will need to apply for access via an NCI contractor organization, Information Management Services (IMS; https://www.imsweb.com/).

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available starting in 2023; 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).
More information

Locations

US(1)