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A Longitudinal Study of COVID-19 Sequelae and Immunity

NCT04411147 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 583

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Michael C Sneller, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-17
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04411147 on ClinicalTrials.gov