Status:
COMPLETED
Prospective Natural History Study of Smoking, Immune Cell Profiles, Epigenetics and COVID-19
Lead Sponsor:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
COVID-19
Eligibility:
All Genders
30-55 years
Brief Summary
Background: Early evidence in the COVID-19 pandemic suggests that smokers are at a higher risk of having severe effects or dying from the disease. Smoking causes changes in immune cells. Researchers ...
Detailed Description
Study Description: This study is a prospective, longitudinal, observational, single-center, exploratory study to collect samples and data that will enable explorations of the interaction between smok...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male and females
- Age 30 to 55 years
- Able to travel to study visits at the NIEHS CRU for required study visits
- Body mass index (BMI) range between 18 and 35 at enrollment
- Must self-identify as a current smoker (cigarettes and/or use of an e-cigarette/vaping device), have smoked for 5 years or longer or identify as a non-smoker, having never used of any other forms of tobacco, nicotine, or smoked marijuana and not currently residing with a smoker (There may be circumstances where the investigator will still want to include the par icipant (for example when a participant has smoked a couple times in the past and the Investigator feels it has been long enough that they can be included as a nonsmoker or they smoked for over 5 years and quit for a day so they can still be included as a smoker). However, these are expected to be rare and will need to be assessed on a case by case basis by the Investigator to maintain scientific integrity)
- EXCLUSION CRITERIA:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- History of confirmed COVID-19 infection
- Current diagnosis of cancer or prior history of cancer, with the exception of nonmelanoma skin cancer because nonmelanoma skin cancers are not relate to tobacco smoking and are very common (approximately 20% of US population will develop these). Treatments are generally topical creams or minor surgery with a very high cure rate. If these treatments occurred in the past, they are unlikely to impact the outcomes we are measuring in our pre and post disease study design
- Bleeding disorder or any reason that a blood sample cannot be provided
- Current pregnancy or lactation, by participant verbal confirmation.
- Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures
Exclusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 24 2023
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04403386
Start Date
June 1 2020
End Date
February 24 2023
Last Update
October 24 2025
Active Locations (1)
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1
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States, 27709