CompletedNot Applicable

Prospective Natural History Study of Smoking, Immune Cell Profiles, Epigenetics and COVID-19

United States132 participantsStarted 2020-06-01

Plain-language 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 think this may be the reason why smokers are more likely to have severe effects from COVID-19. Researchers want to better understand the interaction between smoking history, the immune system, and COVID-19. Objective: To better understand how COVID-19 affects smokers and non-smokers immune systems before and after being infected with the virus. Eligibility: Healthy people ages 30-55 who are a smokers or non-smokers who may potentially contract COVID-19 Design: Participants will be screened over the phone. They will answer questions about their demographics, medical history, medications, and smoking status. Participants will have up to 6 monthly visits. At the first visit, participants will have blood tests. Blood will be drawn through a needle in an arm vein. They will provide a saliva sample in a container and have a cheek swab. The participant will also have a nasal swab to see if they currently have COVID-19. Their height and weight will be taken. They will complete questionnaires about their medical history and smoking status. Participants will then have monthly visits. They will have blood draws to test for COVID-19 antibodies. They will provide a saliva sample in a container and have a cheek swab. The participant will also have a nasal swab to see if they currently have COVID-19. These visits will occur 4 times or until they have a positive antibody result. Participants will have a final visit. They will have blood tests. They will provide a saliva sample in a container and have a cheek swab. The participant will also have a nasal swab to see if they currently have COVID-19. If at any time participants test positive for a COVID-19, they will be rescheduled 14 days or more after they no longer have symptoms....

Who can participate

Age range

30 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Levels of senescent CD16+CD8+ T cells prior to COVID-19 disease and time to COVID-19 disease morbidity (antibody positvity).

Timeframe: At pre and post COVID 19 infection

Trial details

NCT IDNCT04403386

SponsorNational Institute of Environmental Health Sciences (NIEHS)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2022-09-06

View on ClinicalTrials.gov More COVID-19 trials

Plain-language summary

Who can participate

Age range

30 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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)

Prospective Natural History Study of Smoking, Immune Cell Profiles, Epigenetics and COVID-19

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Prospective Natural History Study of Smoking, Immune Cell Profiles, Epigenetics and COVID-19

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria