NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Pediatric SARS-CoV-2 and MIS-C Long-term Follow-up

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000201-I

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: N/A
Max Age: 21 Years

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women

Keywords

COVID-19;
Children;
Outcome;
Sequela;
Infection;
Natural History

Recruitment Keyword(s)

None

Condition(s)

SARS-CoV-2 virus;
Multisystem Inflammatory Disorder of Children (MIS-C)

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

Background:

SARS-CoV-2 is the virus that causes COVID-19. It infects people of all ages. Researchers want to learn more about the effects of this virus on young people.

Objective:

To help researchers better understand how SARS-CoV-2 affects young people after they recover from the initial infection.

Eligibility:

People ages 0-21 who were infected with SARS-CoV-2 or had close contact with someone who was infected but did not get infected themselves.

Design:

Participants will be screened with a medical history.

Participants will have a physical exam. They will complete questionnaires about their health and how SARS-CoV-2 infection has affected them.

Participants will give blood and urine samples. They may give stool samples. Some samples may be used for genetic tests.

Participants will give a mucus sample. A cotton swab will be inserted into the back of their nose.

Participants may have heart function tests. Gel will be put on their chest and a wand will be pressed against their skin to take pictures. Sticky pads will be placed on their body to measure their heartbeat. They will lie on a table that slides into a magnetic resonance imaging (MRI) scanner; pictures will be taken of their heart.

Participants will have lung function tests. Their heartbeat and amount of oxygen in their blood may be checked before, during, and after a 6-minute walk. They may inhale oxygen or gas through a tube, then exhale.

Participants may have chest scans. They will stand in front of or lie down in a scanner. X-rays will make pictures of their lungs.

Participants may be photographed.

Participation will last for 3 years. Participants will have 4-8 visits.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

Survivors and control cohorts:

In order to be eligible to participate in this study as a survivor or as a control, an individual 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. Male or female aged 0 to 21 years (at the NIH CC, minimum age is 3 years).

3. Willing to allow storage of samples and data for future research.

4. At the NIH CC: Has a physician or clinic outside NIH to manage underlying medical conditions, or agrees 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.

In addition, an individual must meet all criteria for one of the following cohorts.

Symptomatic survivor cohort (including MIS-C):

1. Documented prior COVID-19 or MIS-C as evidenced by one of the following:

--detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with Emergency Use Authorization (EUA)/approval from the US Food and Drug Administration (FDA)* and a history of clinical manifestation compatible with COVID-19**, or

--positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA (negative SARS-CoV-2 RNA or antigen or never tested), and a history of clinical manifestation compatible with COVID-19*; or

--meeting CDC case definition for MIS-C.

2. Onset of COVID-19/MIS-C symptoms is at least 4 weeks before baseline visit.

*Participants older than 18 months of age with a positive home antigen test can be enrolled into the study. However, they will be required to provide documentation of positive antibodies consistent with a recent SARS-CoV2 infection prior to scheduling the baseline visit. These participants will be provided with an order to complete SARS-CoV-2 nucleocapsid antibody testing at their nearest LabCorp or Children s National laboratory to confirm prior infection. The antibody test should not be done less than 2 weeks after the positive home antigen to allow sufficient time to mount an antibody response. If the antibody result is not consistent with a recent SARS-CoV2 infection, the participant will be discontinued from the study.

**one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, COVID toes , diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea.

Asymptomatic survivor cohort:

1. Documented prior SARS-CoV-2 infection as evidenced by one of the following:

--detection of SARS-CoV-2 RNA or antigen* in NP swab, saliva, sputum, or other sample source with EUA/approval from the FDA without history of clinical manifestation compatible with COVID-19**; or

--positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA without history of clinical manifestation compatible with COVID-19**

2. Positive SARS-CoV-2 RNA or antigen test is at least 4 weeks before baseline visit.

*Participants older than 18 months of age with a positive home antigen test can be enrolled into the study. However, they will be required to provide documentation of positive antibodies consistent with a recent SARS-CoV2 infection prior to scheduling the baseline visit. These participants will be provided with an order to complete SARS-CoV-2 nucleocapsid antibody testing at their nearest LabCorp or Children s National laboratory to confirm prior infection. The antibody test should not be done less than 2 weeks after the positive home antigen to allow sufficient time to mount an antibody response. If the antibody result is not consistent with a recent SARS-CoV2 infection, the participant will be discontinued from the study.

**one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, COVID toes , diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea.

Healthy contact (control) cohort:

1. No diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 and meets one of the following criteria:

-Lived in the same household as a participant with SARS-CoV-2 infection during the time of illness, or was within approximately 6 feet (2 meters) of the participant for a prolonged period of time, or having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).

-Lives in an area affected by SARS-CoV-2 infection

Parents and guardians:

In order to participate in this study as a parent or guardian, an individual must meet all of the following criteria:

1. Is a parent or guardian of a participant enrolled as a survivor or as a control.

2. Stated willingness to comply with all study procedures and availability for the duration of the study.

3. Willing to allow storage of data for future research.

EXCLUSION CRITERIA:

Survivors and controls:

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

1. Any symptoms suggestive of an ongoing infection within 15 days of baseline visit, including but not limited to fever > 38.2 Degrees Celsius, new or worsening respiratory symptoms (e.g., cough, dyspnea), or new or worsening gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea or abdominal pain).

2. Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study.

3. Pregnancy.

Parents and guardians:

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

1. Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study.

Co-enrollment: Participants may be co-enrolled in other clinical studies, including observational studies and therapeutic trials. However, the study staff should be informed of co-enrollment.


--Back to Top--

Citations:

DeBiasi RL, Song X, Delaney M, Bell M, Smith K, Pershad J, Ansusinha E, Hahn A, Hamdy R, Harik N, Hanisch B, Jantausch B, Koay A, Steinhorn R, Newman K, Wessel D. Severe Coronavirus Disease-2019 in Children and Young Adults in the Washington, DC, Metropolitan Region. J Pediatr. 2020 Aug;223:199-203.e1. doi: 10.1016/j.jpeds.2020.05.007. Epub 2020 May 13. PMID: 32405091; PMCID: PMC7217783.

Feldstein LR, Rose EB, Horwitz SM, Collins JP, Newhams MM, Son MBF, Newburger JW, Kleinman LC, Heidemann SM, Martin AA, Singh AR, Li S, Tarquinio KM, Jaggi P, Oster ME, Zackai SP, Gillen J, Ratner AJ, Walsh RF, Fitzgerald JC, Keenaghan MA, Alharash H, Doymaz S, Clouser KN, Giuliano JS Jr, Gupta A, Parker RM, Maddux AB, Havalad V, Ramsingh S, Bukulmez H, Bradford TT, Smith LS, Tenforde MW, Carroll CL, Riggs BJ, Gertz SJ, Daube A, Lansell A, Coronado Munoz A, Hobbs CV, Marohn KL, Halasa NB, Patel MM, Randolph AG; Overcoming COVID-19 Investigators; CDC COVID-19 Response Team. Multisystem Inflammatory Syndrome in U.S. Children and Adolescents. N Engl J Med. 2020 Jul 23;383(4):334-346. doi: 10.1056/NEJMoa2021680. Epub 2020 Jun 29. PMID: 32598831; PMCID: PMC7346765.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Gina A. Montealegre, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 11C436
10 CENTER DR
BETHESDA MD 20892
(301) 761-7747
montealegrega@mail.nih.gov

Gina A. Montealegre, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 11C436
10 CENTER DR
BETHESDA MD 20892
(301) 761-7747
montealegrega@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04830852

--Back to Top--