A Longitudinal Study of COVID-19 Sequelae and Immunity

COVID-19 Clinical Trial

Official title: A Longitudinal Study of COVID-19 Sequelae and Immunity

Status Recruiting

Clinical 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. 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....

Clinical Trial 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 ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT04411147
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Bryan P Higgins, R.N.
• Phone: (301) 761-7395
• Email: bryan.higgins@nih.gov
• Status: Recruiting
• Start date: June 17, 2020
• Completion date: December 31, 2027