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

Summary

Participation Requirements

Description

This study will establish a cohort of surviving pediatric patients with symptomatic (including COVID-19 and MIS-C) and asymptomatic SARS-CoV-2 infection to study the long-term sequelae of acute infection and the evolution of the immune response over time. Longitudinal follow-up of this cohort will p...

This study will establish a cohort of surviving pediatric patients with symptomatic (including COVID-19 and MIS-C) and asymptomatic SARS-CoV-2 infection to study the long-term sequelae of acute infection and the evolution of the immune response over time. Longitudinal follow-up of this cohort will provide important information about clinical sequelae of acute COVID-19 and MIS-C, characteristics of the immune response to SARS-CoV-2, and the extent and duration of protective immunity. Non-contrast low-radiation chest CT or AP chest radiograph: All participants will undergo 2 chest imaging procedures, one at baseline and one at the final study visit (year 3). Thus, each chest CT would involve an effective dose of 1 mSv to 2 mSv for all age groups, while each chest X-ray would involve approximately 0.01 mSv to 0.06 mSv for all age groups. An average person's annual natural background radiation effective dose is 3 mSv. Participants of childbearing potential will have a pregnancy test prior to this procedure, and participants who are pregnant will be excluded from this procedure and will be withdrawn. Non-contrast cardiac MRI: All participants will undergo 4 non-contrast cardiac MRI procedures during this study. The first cardiac MRI will be performed at baseline (for survivor participants, at least 6 weeks post onset of symptoms), and then cardiac MRI will be performed annually. No cardiac MRI will be performed in any participant requiring conscious sedation. For most participants, the primary risk associated with cardiac MRI is discomfort as participants will be asked to lie still for a long period of time. Additionally, participants may feel claustrophobic during the scan or find the sound of the MRI disturbing. Participants with pacemakers, aneurysm clips, metallic prostheses, shrapnel fragments, welders and metal workers are at risk for injury and will be excluded from having an MRI performed. Participants of childbearing potential will have a pregnancy test prior to this procedure, and participants who are pregnant will be excluded from this procedure and will be withdrawn. Blood draw: The two hazards associated with blood drawing are those of the needle stick and those associated with blood loss. Risks of blood draw are pain at the site of the needle stick, the potential formation of hematoma at the site of the needle stick, and a small potential for infection and/or inflammation at the site of the needle stick. Occasionally, individuals may faint as a result of vasovagal reactions to the procedure. These risks will be minimized by maintaining sterile technique, carefully preparing the site of needle puncture with an alcohol swab, using the smallest size needle or cannula required for the procedure, applying local pressure after removal of the needle or cannula, and having the individual lie down or sit for 5 to 10 minutes after the procedure, if needed. The major risk of repeated blood drawing is anemia. To minimize this risk, the amount of blood drawn for all purposes will be adjusted so as not to exceed the guidelines: for pediatric patients, no more than 5 mL/kg drawn for research purposes in a single day, and no more than 9.5 mL/kg drawn over any 8 week period; for participants 18 years of age or older, no more than 10.5 mL/kg or 550 mL drawn for research purposes over any 8 week period. A total of 26.5 to 30 mL of blood will be drawn at each visit for profile analysis as outlined. Echocardiogram: Echocardiogram is not an invasive procedure. Some patients report mild discomfort during the test. EKG: EKG is not an invasive procedure. Some patients experience minor irritation from the electrodes. There are no other anticipated risks related to completing an EKG. PFT: PFT is not an invasive procedure. Some patients with underlying lung disease may experience wheezing, coughing, shortness of breath, chest tightness, dizziness, headache, and rarely fainting or asthma attack during the testing. If this happens, we will stop the test until symptoms resolve. Completing questionnaires: Participants and/or legal guardians will be asked to complete multiple questionnaires at every visit. To complete the questionnaires will take approximately 25 to 64 minutes. Some of the questions in the questionnaire may be upsetting or uncomfortable. Participants will be informed that they may skip or decline to answer questions that make them feel uncomfortable. If responses on self- or parent-proxy measures indicate significant distress or a clinical elevation (> 2 standard deviations) for depressive symptoms, a study team member will follow up with the participant and a list of resources will be provided. Collection of saliva, NP swab, urine, and stool: There are no risks associated with these procedures. Collection of NP swabs may cause discomfort, gagging, and rarely nosebleed. Genetic testing (optional): This protocol involves genetic testing using whole genome sequencing (WGS) approaches for all participants. Genetic findings may cause emotional stress and may require further medical testing or treatment that is not covered by this study. There may also be medical and psychosocial implications for participants and their families. Following genetic testing, data will be shared in controlled-access public databases for other qualified biomedical investigators to study. However, no personal, identifiable information will be shared in this process, since the results will be identified only by a code. Clinical photography (optional): Taking pictures of the face and body may be embarrassing to some people. These photographs may be published in medical journals, without identifying the participant. We will attempt to preserve the anonymity of the participant as much as possible, while providing the information needed to support the research being published. Participants may decline photographs or place any restrictions on their use. Participants will be given the opportunity to discuss this with the PI or AIs. Storage of samples and data: The primary risk of storing and sharing samples and data is breach of confidentiality. Study samples and data will be kept confidential. Following research testing and publication of the study results, study data will be shared in accordance with NIH policy in a controlled-access public database, but no personal, identifiable information will be shared. Incidental findings of standard procedures: Some standard clinical procedures and evaluations performed as part of this protocol (e.g., echocardiogram, EKG) may result in the discovery of a previously unknown medical condition. If this occurs, the study team will discuss the findings with the participant.

Tracking Information