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NCT04403386 · ClinicalTrials.gov registry record
Prospective Natural History Study of Smoking, Immune Cell Profiles, Epigenetics and COVID-19
A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- 132
- Enrollment target
NCT04403386: Completed study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT04403386 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 132 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04403386 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- 132 participants
- Enrollment target
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....
Primary Outcome
The presence of elevated senescent CD16+CD8+ T cells is an indication of immune dysfunction and could be a susceptibility factor.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2023-02-24 |
What the finished NCT04403386 record still lists
NCT04403386 is an observational study that tracks outcomes without assigning an intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04403386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04403386 about?
NCT04403386 is a clinical study titled "Prospective Natural History Study of Smoking, Immune Cell Profiles, Epigenetics and COVID-19". 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. Resea...
What is the current status of trial NCT04403386?
This trial is currently completed. The enrollment target is 132 participants. The study started on 2020-06-01. Estimated completion is 2023-02-24.
Who is sponsoring clinical trial NCT04403386?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
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