COVID-19NCT04411147
A Longitudinal Study of COVID-19 Sequelae and Immunity
An observational study of COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- COVID-19
- How many people
- 583 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2020to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Clinical
Who may be able to join
- In order to be eligible to participate in this study, all individuals must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age 18 years or older.
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Hemoglobin of 9.0 gm/dl or higher
- Willingness to give consent for the storage of blood samples for research.
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- Have a physician or clinic outside NIH to manage underlying medical conditions or agreeing to establish care with an outside physician or clinic for any medical conditions requiring treatment that may be diagnosed as a result of protocol participation.
- COVID-19 Survivor Group
- Documented prior COVID-19 as evidenced by:
- detection of SARS-CoV-2 RNA or antigen in nasopharyngeal swab, sputum or other sample source with EUA/approval from the FDA; or
- a positive antibody test using an assay that has received emergency use authorization (EUA) from the Food and Drug Administration (FDA) and a history clinical manifestation compatible with COVID-19.
- Greater than 6 weeks since onset of COVID-19 symptoms and no fever for at least 1 week. For individuals with asymptomatic infection, screening will not occur until at least 4 weeks after the last positive SARS-CoV-2 PCR or antigen test.
- COVID-19 Close Contact
- Living in the same household as a COVID-19 survivor during the time of illness or, being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period of time or having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).
- No diagnosis of COVID-19 or current symptoms suggestive of COVID-19
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current abuse of alcohol or other drugs that, in the judgement of the Principal Investigator (PI) could interfere with patient compliance.
- Inability to travel to the NIH Clinical Center for study visits
- Any medical or mental health condition that, in the judgement of the PI, would make the volunteer unable to participate in the study.
- Positive SARS-CoV-2 PCR at screening visit
- Positive test for antibodies to SARS-CoV-2 nucleocapsid protein at the screening visit (control group only).
- History of any of the following in the past 14 days: fever > 38.2 degrees Celsius; new or worsening respiratory symptoms (e.g. cough, dyspnea).
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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
- Conditions
- COVID-19
- Keywords
- Coronavirus, SARS-CoV-2, Medical Sequelae, Antibody and Cell-mediated Immune Responses, Protective Immunity, Natural History
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Close Contacts | 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 | |
| COVID-19 Survivor | Individuals with documented prior COVID-19 infection and who have recovered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Factors for Medical Sequelae in COVID-19 Survivors
Estimate the incidence and risk factors for post-COVID-19 medical sequalae.
Measured: Screening-Month 36
Mental health status in COVID-19 survivors and contacts
Characterize the mental health status of survivors and controls including medical trauma related sequelae
Measured: Screening-Month 36
Medical Sequelae in COVID-19 Survivors
Characterize the medical sequelae and persistent symptoms following recovery from COVID-19 in a cohort of disease survivors.
Measured: Screening-Month 36
Incidence of reinfection with COVID-19
Evaluate survivors for evidence of re-infection with future waves of COVID-19 to determine if initial infection confers long-term protective immunity
Measured: Screening-Month 36
Incidence of clinical silent infection
Determine the incidence of clinically silent infection in household contacts
Measured: Screening-Month 36
Antibody and cell-mediated immune responses to SARS-CoV-2 over time
Characterize evolution of the antibody and T cell-mediated responses to SARS-CoV-2 in survivors over time
Measured: Screening-Month 36
Antibody and cell-mediated immune responses to SARS-CoV-2
Characterize antibody and cell-mediated immune responses to SARS-CoV-2 in disease survivors
Measured: Screening-Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start17 Jun 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael C Sneller, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411147
- Sponsor's protocol ID
- 200123
- Other IDs
- 20-I-0123
- Status last verified
- 9 Jan 2026
- First submitted
- 30 May 2020
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sneller MC, Liang CJ, Marques AR, Chung JY, Shanbhag SM, Fontana JR, Raza H, Okeke O, Dewar RL, Higgins BP, Tolstenko K, Kwan RW, Gittens KR, Seamon CA, McCormack G, Shaw JS, Okpali GM, Law M, Trihemasava K, Kennedy BD, Shi V, Justement JS, Buckner CM, Blazkova J, Moir S, Chun TW, Lane HC. A Longitudinal Study of COVID-19 Sequelae and Immunity: Baseline Findings. Ann Intern Med. 2022 Jul;175(7):969-979. doi: 10.7326/M21-4905. Epub 2022 May 24.
PubMed 35605238
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of COVID-19 Sequelae and Immunity
- ClinicalTrials.gov ID
- NCT04411147
- Acronym / sponsor ID
- 200123
- Conditions
- COVID-19
- Keywords
- Coronavirus, SARS-CoV-2, Medical Sequelae, Antibody and Cell-mediated Immune Responses, Protective Immunity, Natural History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 583 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Close Contacts | – | –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 |
| COVID-19 Survivor | – | –Individuals with documented prior COVID-19 infection and who have recovered |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Clinical
Key inclusion criteria (15 listed)
- In order to be eligible to participate in this study, all individuals must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age 18 years or older.
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Hemoglobin of 9.0 gm/dl or higher
Key exclusion criteria (8 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current abuse of alcohol or other drugs that, in the judgement of the Principal Investigator (PI) could interfere with patient compliance.
- Inability to travel to the NIH Clinical Center for study visits
- Any medical or mental health condition that, in the judgement of the PI, would make the volunteer unable to participate in the study.
- Positive SARS-CoV-2 PCR at screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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.
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
Antibody and cell-mediated immune responses to SARS-CoV-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
Antibody and cell-mediated immune responses to SARS-CoV-2
Time frame: Screening-Month 36
Characterize antibody and cell-mediated immune responses to SARS-CoV-2 in disease survivors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Derived from this study: PubMed 35605238Sneller MC, Liang CJ, Marques AR, Chung JY, Shanbhag SM, Fontana JR, Raza H, Okeke O, Dewar RL, Higgins BP, Tolstenko K, Kwan RW, Gittens KR, Seamon CA, McCormack G, Shaw JS, Okpali GM, Law M, Trihemasava K, Kennedy BD, Shi V, Justement JS, Buckner CM, Blazkova J, Moir S, Chun TW, Lane HC. A Longitudinal Study of COVID-19 Sequelae and Immunity: Baseline Findings. Ann Intern Med. 2022 Jul;175(7):969-979. doi: 10.7326/M21-4905. Epub 2022 May 24.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Sneller, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Factors for Medical Sequelae in COVID-19 Survivors (time frame: Screening-Month 36). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.