A Study to Determine Late Outcomes and Immunological Responses in Children With/Without Multisystem Inflammatory Syndrome After SARS-CoV-2

Overview

About this study

The purpose of this study is to assess short- and long-term clinical outcomes and immune responses after SARS-CoV-2 infection and/or MIS-C in children (defined as individuals who have not yet reached their 21st birthday). Participants will be identified through active recruitment measures within hospitals and through ambulatory and laboratory-based databases of SARS-CoV-2 positive children.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Participants < 21 years AND meets one or more of the following criteria:
- SARS-CoV-2 detection from a respiratory specimen; and/or
- Meets criteria for MIS-C; and/or
- Meets criteria for MIS-C, except has involvement of only 1 organ system.
Cases meeting clinical criteria for MIS-C but without known SARS-CoV-2 exposure, and who are being treated as MIS-C by the treating physician, but with negative SARS-CoV-2 PCR and pending or negative antibody testing, may be enrolled as participants. If subsequent antibody testing is positive, cases will be labelled as confirmed MIS-C.
If SARS-CoV-2 antibody testing is negative, participants will be labeled at the end of the study as suspected/not confirmed MIS-C.

Exclusion Criteria:

Participant and/or parent/guardian who is not able to understand or be willing to provide informed consent and where applicable assent.
- Note, for this observational cohort study, participation in other COVID-19 studies is not an automatic exclusionary criterion.
- Nonetheless, blood draw restrictions will be strictly adhered to.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Rana Chakraborty, M.D., D.Phil.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Rana Chakraborty, M.D., D.Phil.

Closed for enrollment

More information

Publications

Publications are currently not available

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