A Longitudinal Study of COVID-19 Sequelae and Immunity

June 5, 2026 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
583

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary Clinical

Description

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, all individuals must meet all of the following criteria:

  1. Stated willingness to comply with all study procedures and availability for the duration of the study
  2. Age 18 years or older.
  3. Ability of participant to understand and the willingness to sign a written informed consent document.
  4. Hemoglobin of 9.0 gm/dl or higher
  5. Willingness to give consent for the storage of blood samples for research.
  6. 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

  1. Documented prior COVID-19 as evidenced by:

    1. detection of SARS-CoV-2 RNA or antigen in nasopharyngeal swab, sputum or other sample source with EUA/approval from the FDA; or
    2. 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.
  2. 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

  1. 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).
  2. No diagnosis of COVID-19 or current symptoms suggestive of COVID-19

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Current abuse of alcohol or other drugs that, in the judgement of the Principal Investigator (PI) could interfere with patient compliance.
  2. Inability to travel to the NIH Clinical Center for study visits
  3. Any medical or mental health condition that, in the judgement of the PI, would make the volunteer unable to participate in the study.
  4. Positive SARS-CoV-2 PCR at screening visit
  5. Positive test for antibodies to SARS-CoV-2 nucleocapsid protein at the screening visit (control group only).
  6. 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).
  7. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Screening-Month 36
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
Screening-Month 36
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.
Screening-Month 36
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
Screening-Month 36
Incidence of clinical silent infection
Time Frame: Screening-Month 36
Determine the incidence of clinically silent infection in household contacts
Screening-Month 36
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
Screening-Month 36
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
Screening-Month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael C Sneller, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 9, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200123
  • 20-I-0123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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