A Longitudinal Study of COVID-19 Sequelae and Immunity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04411147|
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : August 28, 2020
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.
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.
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
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:
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....
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||900 participants|
|Official Title:||A Longitudinal Study of COVID-19 Sequelae and Immunity|
|Actual Study Start Date :||June 17, 2020|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2027|
Individuals without COVID-19 diagnosis, lived in same home as a survivor during illness, were within 6 feet of a COVID-19 case for a prolonged period of time or had direct contact with secretions
Individuals with documented prior COVID-19 infection and who have recovered
- Medical Sequelae in COVID- 19 Survivors [ Time Frame: Screening-Month 36 ]Characterize the medical sequelae and persistent symptoms following recovery from COVID-19 in a cohort of disease survivors.
- Risk Factors for Medical Sequelae in COVID-19 Survivors [ Time Frame: Screening-Month 36 ]Estimate the incidence and risk factors for post-COVID- 19 medical sequalae.
- Antibody and cell-mediated immune responses to SARSCoV-2 [ Time Frame: Screening-Month 36 ]Characterize antibody and cell-mediated immune responses to SARS-CoV-2 in disease survivors
- Antibody and cell-mediated immune responses to SARSCoV-2 over time [ Time Frame: Screening-Month 36 ]Characterize evolution of the antibody and T cell-mediated responses to SARS-CoV-2 in survivors over time
- Incidence of reinfection with COVID-19 [ Time Frame: Screening-Month 36 ]Evaluate survivors for evidence of re-infection with future waves of COVID-19 to determine if initial infection confers long-term protective immunity
- Incidence of clinical silent infection [ Time Frame: Screening-Month 36 ]Determine the incidence of clinically silent infection in household contacts
- Mental health status in COVID-19 survivors and contacts [ Time Frame: Screening-Month 36 ]Characterize the mental health status of survivors and controls including medical trauma related sequelae
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411147
|Contact: Bryan P Higgins, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Michael C Sneller, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|