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The C3I COVID-19 Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04506528
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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

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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

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.



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04506528


Contacts
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Contact: Stevens S Smith, PhD 6082627563 sss@ctri.wisc.edu
Contact: Tanya R Schlam, PhD 6082624149 trschlam@ctri.wisc.edu

Locations
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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
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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
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, 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.

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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    Key Record Dates
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).

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