Clinical trial · Observational
COVID EHR COHORT at the University of Wisconsin
NCT04506528CI-TRIAL-00060621CEC-UWcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| COVID-19 | — | UNRESOLVED | — |
| Immunosuppression Disorders | — | UNRESOLVED | — |
| Nicotine Dependence | — | UNRESOLVED | — |
| Pulmonary Disease | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with COVID-19
- description
- Analyses of the cohort data will include (1) all patients, or (2) hospitalized patients meeting specific inclusion criteria.
Primary outcomes (2)
- measure
- Mortality due to COVID-19
- timeFrame
- February 1, 2020, through January 31, 2022
- description
- In analyses of hospitalized patients, all-cause mortality in patients with COVID-19 illness vs discharge from hospital (binary outcome)
- measure
- COVID-19 Severity
- timeFrame
- February 1, 2020, through January 31, 2022
- description
- In analyses of hospitalized patients, COVID-19 severity as measured by intubation for respiratory support (i.e., patient required intubation during hospitalization; binary outcome)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * N/A
References
Publications (7)
- BACKGROUNDLoh, W.-Y. (2002). Regression trees with unbiased variable selection and interaction detection. Stat. Sinica, 12:361-386.
- BACKGROUNDLoh, W.-Y. (2011). Classification and regression trees. WIRES Data Min. Knowl., 1:14-23.
- BACKGROUNDLoh 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 29671896
- BACKGROUNDLoh, 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.
- BACKGROUNDNolan 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 35965473
- DERIVEDGu D, Tsoh JY. California Healthy Places Index and COVID-19 hospitalization risk: a patient-level analysis. BMC Public Health. 2026 May 14;26(1):2068. doi: 10.1186/s12889-026-27732-3. PMID 42135725
- DERIVEDFiore 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.