Study Overview

How to Join the COVID MUSIC STUDY

Joining the COVID MUSIC Study will help investigators learn more about the occurrence and time course of heart problems (cardiac dysfunction, coronary artery enlargement, heart rhythm disturbances); problems with function of other organs, inflammation, and medical events after MIS-C. It will help doctors predict which children, teens, and young adults are at greatest risk, and also provide medical information that scientists can correlate with their studies about the biologic mechanisms of MIS-C.

Who Can Join the Study?

To be a part of the COVID MUSIC study, you must be followed for care at one of the participating study sites and be able to attend in-person follow-up for routine clinical and/or study testing as needed. You also must be consented within 1 year of MIS-C diagnosis. The study lasts up to 5 years.

MUSIC participants will now have the opportunity to enroll in RECOVER.

In order to join this study, participants must meet specific criteria outlined below which meet the CDC definition of MIS-C, 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.

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.

What is Involved in Participating?

In-Person Visit:

We will try to collect information for the MUSIC study at the same time as routine care clinic visits, which 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.

Things to Know About Participating

Length of Participation

The study lasts up to 5 years, with study visits coordinated with your regular, clinical care visits when possible. As part of the study, we will gather information from participants’ medical records, reach out to participants annually until 5 years after the MIS-C diagnosis to see how participants are doing.

Compensation

Tests that are done for research that are not part of regular clinical care will be provided free of charge. Participants and families will be compensated for time and effort.

Rights and Responsibilities

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.

Privacy

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.

Study Locations

Leading children’s medical centers across the United States and Canada are participating in the COVID MUSIC Study. View the map to find a location near you.

View Study Locations