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Abstract Number: 1933

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

Gina Montealegre Sanchez1, Roberta DeBiasi2, Lauren Arrigoni2, Kevin Rubenstein3, Jason Liang4, James Bost2, Marcin Gierdalski2, Max Wolff3, Mallory Barrix2, Maureen Edu2, Saira Huq2, Shera Weyers3, Patricia Bandettini5, Dorothy Bulas2, Tom Burklow6, Marcus Chen5, Sanchita Das6, Robin Dewar3, Joseph Fontana5, Ashraf Harahsheh2, Linda Herbert2, Anastassios Koumbourlis2, Andrew Lipton5, Laura Olivieri2, Dinesh Pillai2, Vandana Sachdev5, Craig Sable2, Audrey Thurm7, Evrim Turkbey6, Alexandra Yonts2, Jonathan Zember2, Eric Vilain2, Meghan Delaney2, Luigi Notarangelo4, David Wessel8 and Karyl Barron4, 1NIAID/NIH, Garrett Park, MD, 2Children's National Hospital, Washington, DC, 3Frederick National Laboratory for Cancer Research, Frederick, MD, 4NIAID/NIH, Bethesda, MD, 5NHLBI/NIH, Bethesda, MD, 6CC/NIH, Bethesda, MD, 7NIMH/NIH, Bethesda, MD, 8Children's National Hospital, Washington, MD

Meeting: ACR Convergence 2022

Keywords: COVID-19, longitudinal studies, Pediatric rheumatology

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Session Information

Date: Monday, November 14, 2022

Title: Pediatric Rheumatology – Clinical Poster III: Other

Session Type: Poster Session D

Session Time: 1:00PM-3:00PM

Background/Purpose: The long-term complications of SARS-CoV-2 and MIS-C in children are unknown. PECOS, a joint study at the National Institutes of Health (NIH) Clinical Center and Children’s National Hospital was initiated in July 2021 with the following study objectives:

  • Characterizing long-term clinical manifestations and sequelae following recovery from SARS-CoV-2 infection.
  • Characterizing the role of genetics and immunological factors in long-term outcomes.
  • Characterizing changes in the SARS-CoV-2 immune response over time.

Methods: PECOS is a prospective longitudinal study, funded by the National Institute of Allergy and Infectious Diseases (NIAID), NIH, to enroll 1000 individuals, including 650 COVID-19 survivors (S) and 350 healthy controls (HC). Participants (0-21 years) are evaluated on a regular basis for a total of 3 years. Evaluation includes history/physical exam, review of systems, a battery of laboratory tests, and cardiopulmonary testing and imaging. Validated survey instruments are used to evaluate neurodevelopment progress, patient reported outcomes, and impact of the pandemic on quality of life and mental health. Blood samples are assessed for antibody kinetics, T cell responses, and host genetics; stool for viral shedding and microbiome. Samples are stored in a biorepository for future testing.

Results: As of May 27, 2022, 804 individuals have been screened. 604 (75%) were found to be eligible and 418 (52%) were enrolled. Of the 418, 285 (68%) are S and 133 (32%) are HC. Preliminary results presented in this abstract are from participants who have completed baseline testing.

The overall demographics of the S and HC cohorts were similar for sex, and ethnicity with a discrete representation of all ages, and SARS-CoV-2 variants of concern.

Acute COVID-19 survivors were more likely to report GI symptoms at baseline compared to HC. There were no significant differences observed on baseline physical exam. Significant differences were seen in baseline parent-reported global health, cognitive functioning, pain intensity, and fatigue scores, with S scores worse than HC, and a larger percentage of S scoring >1SD below the normed mean. There were no significant differences in anxiety, social relationships, peer relationship, sleep disturbance, or depressive symptoms, with both groups demonstrating similar percentages scoring >1SD below the normed mean. Additional data analysis is in progress for pulmonary, cardiac, immunologic, and genetic testing.

Conclusion: This study establishes a well characterized, large, longitudinal cohort of pediatric survivors who have recovered from SARS-CoV-2 infection and HC. Preliminary analysis suggests that pediatric COVID-19 S are more likely to experience/report GI symptomatology compared to HC. Preliminary results also reveal that COVID-19 S are more likely to have worse scores in overall global health, cognitive and physical functioning, pain interference, and fatigue. Not unexpectedly, many HC and S reported concerns with peer relationships, anxiety, and sleep disturbance, which may be secondary to the prolonged social isolation and life changes associated with the pandemic.


Disclosures: G. Montealegre Sanchez, None; R. DeBiasi, None; L. Arrigoni, None; K. Rubenstein, None; J. Liang, None; J. Bost, None; M. Gierdalski, None; M. Wolff, None; M. Barrix, None; M. Edu, None; S. Huq, None; S. Weyers, None; P. Bandettini, None; D. Bulas, None; T. Burklow, None; M. Chen, None; S. Das, None; R. Dewar, None; J. Fontana, None; A. Harahsheh, OP2 DRUGS (“OP2”); L. Herbert, None; A. Koumbourlis, None; A. Lipton, None; L. Olivieri, None; D. Pillai, None; V. Sachdev, None; C. Sable, None; A. Thurm, None; E. Turkbey, None; A. Yonts, None; J. Zember, None; E. Vilain, Bionano Genomics Inc.; M. Delaney, None; L. Notarangelo, None; D. Wessel, None; K. Barron, None.

To cite this abstract in AMA style:

Montealegre Sanchez G, DeBiasi R, Arrigoni L, Rubenstein K, Liang J, Bost J, Gierdalski M, Wolff M, Barrix M, Edu M, Huq S, Weyers S, Bandettini P, Bulas D, Burklow T, Chen M, Das S, Dewar R, Fontana J, Harahsheh A, Herbert L, Koumbourlis A, Lipton A, Olivieri L, Pillai D, Sachdev V, Sable C, Thurm A, Turkbey E, Yonts A, Zember J, Vilain E, Delaney M, Notarangelo L, Wessel D, Barron K. PECOS (Pediatric SARS-CoV-2 MIS-C Long-term Outcomes Study): Preliminary Results [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/pecos-pediatric-sars-cov-2-mis-c-long-term-outcomes-study-preliminary-results/. Accessed .
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