Long-Term Outcomes after the Multisystem Inflammatory Syndrome In Children

MIS-C appears to be a late complication of COVID-19. While it is normal for the immune system to fight off an infection, young people with MIS-C seem to have their immune systems turned on too strongly. This can affect many organ systems, including the heart. When young people are diagnosed with MIS-C, they may have decreased heart function (meaning how the heart squeezes), enlargement of the coronary arteries (the blood vessels that bring oxygenated blood to the heart), and heart rhythm problems. However, we do not know if these problems last or go away and if there are long-term effects of MIS-C on other organ systems.

In order to join this study, participants must meet specific criteria outlined below, and must sign a consent form. For some of these criteria, we will also need to look at medical record information to help us determine if someone is eligible. Contact us at [email protected] for more information.

Eligibility Criteria:

• Under the age of 21 years old.
• A fever at or greater than 38°C (100.4°F) for 24 hours or more.
• Laboratory results that show inflammation, including (but not limited to) one or more of the following: an elevated CRP, ESR, fibrinogen, procalcitonin, d-dimer, ferritin, LDH, or IL-6, elevated neutrophils, reduced lymphocytes and low albumin.
• Illness severe enough to need a hospital stay. Specific details of the hospitalization include:
• Multisystem (2 or more) organs involved, based on clinical judgment from record review, discharge diagnosis, laboratory or diagnostic tests.
• Organ system involvement includes but is not limited to cardiac, renal, respiratory, hematologic including coagulopathy, gastrointestinal including liver, dermatologic or neurological.
• A positive test for current or recent COVID (SARS-CoV-2) infection by one of the following:
• The RT-PCR Rapid Test, serology test, or antigen test or
• COVID-19 exposure within the 4 weeks prior to the onset of symptoms.

Exclusion Criteria: No other possible diagnosis that would explain symptoms, such as bacterial sepsis, murine typhus, staphylococcal or streptococcal shock syndromes.

The study lasts up to 5 years, during which participants may have up to 7 visits. We will try to schedule these visits at the same time as routine care clinic visits. These will usually occur about 2 weeks, 6 weeks, and 6 months after hospital discharge. If a participant has low function/squeeze of the heart, coronary artery enlargement, or heart rhythm problems, doctors may want to see them in clinic more often as part of routine care.

Medical Chart Review: We will review medical charts to obtain information during the hospital course and outpatient follow-up clinic visits related to MIS-C. We will also obtain information and reports from the heart imaging tests that are performed as part of medical care.

Yearly Contact: We will look at participants’ medical charts and contact them to conduct a brief annual medical history form at 1 year and then once a year until 5 years after diagnosis of MIS-C. We will ask about any operations, tests, or times in the hospital, as well as about how they are doing. We will also ask about medications or new health problems. We may contact participants by phone, text, email, or we may schedule a telehealth, or virtual, visit. Each yearly visit will take about 20 minutes.

Genetic Testing of Participant and Biological Parents (Optional): We are trying to understand how differences in DNA (genetic make-up) may make young people susceptible to developing MIS-C. When studying genetic variation, it is also helpful to have samples from the biological parents of the person with the disease to compare the genetic data. These blood or saliva samples from participants and their parents are optional and can be collected at any time during the study.

Tests that are done for research that are not part of regular care will be provided free of charge. Participants and caregivers will receive money to help with travel on visit days and to help compensate for time and effort.

It is up to participants and their families to decide to be in the study. Once in, they may leave the study at any time. Being in the study will not affect other medical care now, or in the future.

Participants have a right to privacy and participation in this research study will remain confidential. Participants’ names will not be used in any published report of information from this study.