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A Longitudinal Study of COVID-19 Sequelae and Immunity

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ClinicalTrials.gov Identifier: NCT04411147
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief 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....


Condition or disease
COVID-19

Detailed Description:
Coronavirus disease-2019 (COVID-19) is a newly recognized viral disease primarily involving the respiratory tract. The world is currently experiencing COVID-19 pandemic with a significant portion of those infected developing severe disease manifestations including pneumonia, acute respiratory distress syndrome with respiratory failure, and, in some cases, death. The clinical characteristics and spectrum of disease severity of acute COVID-19 are currently being defined. Since COVID-19 is a new disease, very little is known about possible clinical sequelae that may persist after resolution of the acute infection. In addition, the characteristics of the initial cellular immune and antibody response to SARS-CoV-2 (the virus that causes COVID-19) have not been fully defined and it is not known if the immune responses generated by infection provides long-term protective immunity. The purpose of this study is to establish a longitudinal cohort that has recovered from COVID-19 and characterize the clinical sequelae of acute infection, characterize the immune response to the virus, and follow the evolution of the immune response over time and determine the extent to which natural immunity is protective against re-infection.

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Study of COVID-19 Sequelae and Immunity
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2027

Group/Cohort
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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Antibody and cell-mediated immune responses to SARSCoV-2 [ Time Frame: Screening-Month 36 ]
    Characterize antibody and cell-mediated immune responses to SARS-CoV-2 in disease survivors

  4. Antibody and cell-mediated immune responses to SARSCoV-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

  5. 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

  6. Incidence of clinical silent infection [ Time Frame: Screening-Month 36 ]
    Determine the incidence of clinically silent infection in household contacts

  7. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary Clinical
Criteria
  • 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. 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).
  6. Pregnancy

INCLUSION OF VULNERABLE PARTICIPANTS:

Pregnant Women will not be enrolled in the protocol. If a woman is pregnant at the time of 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411147


Contacts
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Contact: Bryan P Higgins, R.N. (301) 761-7395 bryan.higgins@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Michael C Sneller, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04411147    
Other Study ID Numbers: 200123
20-I-0123
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 25, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Coronavirus
SARS-CoV-2
Medical Sequelae
Antibody and Cell-mediated Immune Responses
Protective Immunity