A Longitudinal Study of COVID-19 Sequelae and Immunity

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    800
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 4 October 2022
pneumonia
fever
chest x-ray
respiratory failure
covid-19
SARS
antibody test
nasopharyngeal swab
asymptomatic infection
Accepts healthy volunteers

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....

Description

Title: A Longitudinal Study of COVID-19 Sequelae and Immunity

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 SARSCoV-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

Endpoint

Determine the incidence of clinically silent infection in household contacts

Characterize the mental health status of survivors and controls including medical trauma related sequelae

Establish a clinically well characterized cohort of persons recovered from COVID-19 and close contacts of persons with COVID-19

Details
Condition COVID-19
Clinical Study IdentifierNCT04411147
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

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
History of any of the following in the past 14 days: fever > 38.2 degrees Celsius; new
Positive test for antibodies to SARS-CoV-2 nucleocapsid protein at the screening visit
(control group only)
or worsening respiratory symptoms (e.g. cough, dyspnea)
Pregnancy
INCLUSION OF VULNERABLE PARTICIPANTS
Co-enrollment Guidelines: Co-enrollment in other observational studies is allowed and is
Pregnant Women will not be enrolled in the protocol. If a woman is pregnant at the time of
subject to approval of the principal investigator (PI)
screening she will not be enrolled until the end of her pregnancy because important
baseline research assessments (e.g. leukapheresis, chest x-ray, pulmonary function testing)
should not be done during pregnancy
Children will not be included in this study. Due to the rarity of COVID-19 in children (as
of 4/11/2020 in Maryland, <2% of cases occurred in children), it would not be possible to
recruit enough children to address the protocol research objectives. In addition, pediatric
restrictions for the volume of blood permitted to be drawn for research purposes and the
more than minimal risk of apheresis in children would severely limit the ability to conduct
the immunologic studies described in this protocol
Participation of Employees
NIH employees may be enrolled in this study as this population meets the study entry
criteria
Neither participation nor refusal to participate as a participant in the research will have
an effect, either beneficial or adverse, on the participant s employment or position at
NIH
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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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