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

NCT04403386 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2026-03-06

No results posted yet for this study

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....

Conditions

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

  • Stavros Garantziotis, M.D. · National Institute of Environmental Health Sciences (NIEHS)

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-09-06
Completion
2023-02-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04403386 on ClinicalTrials.gov