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Abstract Number: 2182

PECOS (Pediatric SARS-CoV-2 MIS-C Long-term Outcomes Study): Preliminary Results

Gina Montealegre Sanchez1, Lauren Arrigoni2, Kevin Rubenstein3, Max Wolff4, Mallory Barrix2, C. Jason Liang5, James Bost6, Meghan Delaney7, Luigi Notarangelo8, Karyl Barron9 and Roberta DeBiasi10, and PECOS Study Team, 1Division of Clinical Research (DCR), National Institute of Allergy and Infectious Diseases (NIAID),National Institutes of Health (NIH), Bethesda, MD, 2Center for Cancer and Immunology Research (CCIR), Children's National Research Institute, Washington, DC, 3Clinical Monitoring Research Program Directorate (CMRPD), National Cancer Institute Frederick National Laboratory for Cancer Research, Frederick, MD, 4Clinical Research Directorate (CRD), National Cancer Institute Frederick National Laboratory for Cancer Research, Frederick, MD, 5Biostatistics Research Branch, NIAID, NIH, Bethesda, MD, 6Division of Biostatistics and Study Methodology and Center for Translational Research, Children's National Research Institute, Washington, DC, 7Department of Pathology and Laboratory Medicine, Children's National Hospital, Washington, DC, 8Laboratory of Clinical Immunology and Microbiology (LCIM), NIAID, Bethesda, MD, 9Division of Clinical Research (DCR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, 10Children's National Hospital and Research Institute, Washington, DC

Meeting: ACR Convergence 2024

Keywords: COVID-19, longitudinal studies, Outcome measures

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Session Information

Date: Monday, November 18, 2024

Title: Pediatric Rheumatology – Clinical Poster III

Session Type: Poster Session C

Session Time: 10:30AM-12:30PM

Background/Purpose: The long-term sequelae of SARS-CoV-2 infection in children are unknown. PECOS is a large prospective observational cohort study with the main objective to characterize the long-term clinical manifestations and sequelae following recovery from SARS-CoV-2 infection.

 This is an ongoing multicenter study at the National Institute for Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and Children’s National Hospital in Washington, DC.

Methods: Participants (< 21 years) with laboratory-confirmed infection were enrolled as COVID Survivors (S). Participants (< 21 years) without history of COVID infection and negative SARS-CoV-2 RT-PCR, and serology were enrolled as uninfected/healthy controls (HC). COVID Survivors and HC completed a baseline visit and were expected to return every 6-12 months, respectively, for 3 years.

Demographics, medical/vaccine history, review of systems, physical exam, cardiopulmonary testing and imaging, and laboratory test were collected. Validated survey instruments were used to evaluate patient reported outcomes (PROMIS), and impact of the pandemic on quality of life and mental health. Primary outcomes were cohort comparisons at baseline for abnormalities on all measurements. Blood and stool were stored in a biorepository for future testing.

Results: As of June 30, 2023, 1765 individuals were screened. 1445 (82%) were found to be eligible and 978 (55%) were enrolled. Of those, 720 (74%) were Survivors and 258 (26%) HC. Majority of the Survivors had mild symptomatic disease. 83% of all participants eligible for COVID-19 vaccination had received at least one dose.

Preliminary results presented in this abstract include 654 enrolled participants (541 Survivors and 133 HC) who completed a baseline visit.

At study enrollment, COVID Survivors were more likely to report ongoing constitutional, ENT, respiratory and gastrointestinal symptoms compared to HC. Survivors had higher incidence on chest x-ray of perihilar peribronchiolar thickening; chest CT, pulmonary function tests, and electrocardiogram abnormalities were similar between cohorts. Survivors showed non-significant trend for abnormal echocardiogram including mild myocardial systolic dysfunction, mild mitral valve regurgitation, and small pericardial effusions but no differences in mean coronary artery Z scores. Survivors had significantly worse parent-reported performance (median T scores) in 6 of 10 PROMIS domains including Global Health, Physical Functioning and Mobility, Cognitive Functioning, Pain Interference, Fatigue and Sleep Disturbance, but no differences for Anxiety, Depressive Symptoms or Peer Relationships reflecting the potential effect of the pandemic and post-pandemic period.

 

Conclusion: This study establishes a well characterized, large, longitudinal cohort of pediatric COVID survivors and HC. Preliminary reports are consistent with important differences as well as similarities among both cohorts. Continued analysis of this cohort will help identify clinical sequelae of COVID in children and provide an opportunity to explore pathophysiological biomarkers of pediatric SARS-CoV-2 infection.

Funded by DCR, DIR, NIAID. Contract # 75N91019D00024 (NCI)


Disclosures: G. Montealegre Sanchez: None; L. Arrigoni: None; K. Rubenstein: None; M. Wolff: None; M. Barrix: None; C. Liang: None; J. Bost: None; M. Delaney: None; L. Notarangelo: None; K. Barron: None; R. DeBiasi: None.

To cite this abstract in AMA style:

Montealegre Sanchez G, Arrigoni L, Rubenstein K, Wolff M, Barrix M, Liang C, Bost J, Delaney M, Notarangelo L, Barron K, DeBiasi R. PECOS (Pediatric SARS-CoV-2 MIS-C Long-term Outcomes Study): Preliminary Results [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/pecos-pediatric-sars-cov-2-mis-c-long-term-outcomes-study-preliminary-results-2/. Accessed .
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