A Study to Determine Late Outcomes and Immunological Responses in Children With/Without Multisystem Inflammatory Syndrome After SARS-CoV-2
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-008906
Sponsor Protocol Number: PRISM-01
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 |
|
More information
Publications
Publications are currently not available