The C3I COVID-19 Project
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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 : July 21, 2021
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Condition or disease |
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Covid19 Cancer Nicotine Dependence Pulmonary Disease Cardiovascular Diseases Immunosuppression Disorders |

Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 1000000 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 2023 |
Estimated Study Completion Date : | December 2023 |

Group/Cohort |
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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.
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- 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)
- 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

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

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
Contact: Stevens S Smith, PhD | 6082627563 | sss@ctri.wisc.edu | |
Contact: Tanya R Schlam, PhD | 6082624149 | trschlam@ctri.wisc.edu |
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 |
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 |
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: | July 21, 2021 |
Last Verified: | July 2021 |
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 |
COVID-19 |
COVID-19 Cardiovascular Diseases Tobacco Use Disorder Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |