Ignite Creation Date:
2024-05-06 @ 2:46 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04411147
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2020-05-30
Brief Title:
A Longitudinal Study of COVID-19 Sequelae and Immunity
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Longitudinal Study of COVID-19 Sequelae and Immunity
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
COVID-19 is a disease caused by the SARS-CoV-2 virus It infects the respiratory tract Some people who get COVID-19 have only mild symptoms But for others infection leads to pneumonia respiratory failure and in some cases death Researchers want to learn more about any effects that may persist after people recover from COVID-19
Objective
To learn about any long-term medical problems that people who have recovered from COVID-19 might have and whether they develop an immune response to SARS-CoV-2 that provides protection against reinfection
Eligibility
People age 18 and older who have recovered from documented COVID-19 or were in close contact with someone who had COVID-19 but did not get the infection
Design
Participants will be screened over 2 visits During visit 1 they will answer questions about any symptoms they are having and will be tested for SARS-CoV-2 infection which will involve a nasal swab sample or other FDA approved test If the test is negative they will proceed to the second visit which will include
Physical examination
Medical history
Mental health interview which may be recorded if the participant agrees
Chest x-ray for recovered COVID-19 participants only
Blood and urine tests
Pregnancy test if needed
Lung function test for recovered COVID-19 participants only
6-minute walk test for recovered COVID-19 participants only
Questionnaires about their general and mental health
Leukapheresis to collect white blood cells optional
Participants will be put into 1 of 2 groups the COVID-19 group or the close contact group
Participants will have study visits every 6 months for 3 years They will repeat some of the screening tests Participants in the COVID-19 group may have visits more often if they develop symptoms that suggest re-infection with SARS-CoV-2
COVID-19 is a disease caused by the SARS-CoV-2 virus It infects the respiratory tract Some people who get COVID-19 have only mild symptoms But for others infection leads to pneumonia respiratory failure and in some cases death Researchers want to learn more about any effects that may persist after people recover from COVID-19
Objective
To learn about any long-term medical problems that people who have recovered from COVID-19 might have and whether they develop an immune response to SARS-CoV-2 that provides protection against reinfection
Eligibility
People age 18 and older who have recovered from documented COVID-19 or were in close contact with someone who had COVID-19 but did not get the infection
Design
Participants will be screened over 2 visits During visit 1 they will answer questions about any symptoms they are having and will be tested for SARS-CoV-2 infection which will involve a nasal swab sample or other FDA approved test If the test is negative they will proceed to the second visit which will include
Physical examination
Medical history
Mental health interview which may be recorded if the participant agrees
Chest x-ray for recovered COVID-19 participants only
Blood and urine tests
Pregnancy test if needed
Lung function test for recovered COVID-19 participants only
6-minute walk test for recovered COVID-19 participants only
Questionnaires about their general and mental health
Leukapheresis to collect white blood cells optional
Participants will be put into 1 of 2 groups the COVID-19 group or the close contact group
Participants will have study visits every 6 months for 3 years They will repeat some of the screening tests Participants in the COVID-19 group may have visits more often if they develop symptoms that suggest re-infection with SARS-CoV-2
Detailed Description:
Study Description
This is a longitudinal cohort study to evaluate the clinical sequelae of acute COVID-19 and characterize the immune response to SARS-CoV-2 Household contacts of the COVID-19 cohort will also be recruited and serve as a control group
Objectives
Characterize the medical sequalae and persistent symptoms following recovery from COVID-19 in a cohort of disease survivors
Estimate the incidence and risk factors for post-COVID-19 medical sequalae
Characterize antibody and cell-mediated immune responses to SARS-CoV- 2 in disease survivors
Characterize evolution of the antibody and T cell-mediated responses to SARS-CoV-2 in survivors over time
Evaluate survivors for evidence of re-infection with future waves of COVID-19 to determine if initial infection confers long-term protective immunity
Determine the incidence of clinically silent infection in household contacts
Characterize the mental health status of survivors and controls including medical trauma related sequelae
Endpoint
Establish a clinically well characterized cohort of persons recovered from COVID-19 and close contacts of persons with COVID-19
This is a longitudinal cohort study to evaluate the clinical sequelae of acute COVID-19 and characterize the immune response to SARS-CoV-2 Household contacts of the COVID-19 cohort will also be recruited and serve as a control group
Objectives
Characterize the medical sequalae and persistent symptoms following recovery from COVID-19 in a cohort of disease survivors
Estimate the incidence and risk factors for post-COVID-19 medical sequalae
Characterize antibody and cell-mediated immune responses to SARS-CoV- 2 in disease survivors
Characterize evolution of the antibody and T cell-mediated responses to SARS-CoV-2 in survivors over time
Evaluate survivors for evidence of re-infection with future waves of COVID-19 to determine if initial infection confers long-term protective immunity
Determine the incidence of clinically silent infection in household contacts
Characterize the mental health status of survivors and controls including medical trauma related sequelae
Endpoint
Establish a clinically well characterized cohort of persons recovered from COVID-19 and close contacts of persons with COVID-19
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-I-0123 | None | None | None |