Pediatric SARS-CoV-2 long term outcomes study (PECOS): cross sectional analysis at baseline

Abstract

Background: PECOS is an ongoing study aimed to characterize long-term outcomes following pediatric SARS-CoV-2 infection.

Methods: This is a cross-sectional analysis of infected and uninfected cohorts at baseline. Participants (0-21 years) with laboratory-confirmed SARS-CoV-2 infection were enrolled as infected. Uninfected were defined as individuals without history or laboratory evidence of SARS-CoV-2 infection. Outcome measures included demographics, medical history, review of symptoms, physical exam, cardiopulmonary evaluation and validated psychological and developmental surveys. Primary outcomes were cohort comparisons for abnormalities on all measures.

Results: 654 participants (541 infected, 113 uninfected) completed baseline visits by June 30, 2023. Infected participants were more likely to report constitutional (OR: 2.24), HEENT (OR: 3.74); respiratory (OR: 2.41), or gastrointestinal (OR: 2.58) symptoms. Infected had worse scores in domains of Pain, Fatigue, Global Health, Physical and Cognitive functioning, Mobility and Sleep disturbances when compared to uninfected controls using Patient Reported Outcomes. Cardiopulmonary findings were similar among cohorts.

Conclusions: The first report of this ongoing longitudinal study demonstrates that infected participants were more likely to report symptoms compared to uninfected controls, which may affect performance and quality of life of these individuals. Longitudinal data will increase understanding of long-term effects of SARS-CoV-2 infection in children.

Clinicaltrials: gov Identifier: NCT04830852 IMPACT: This study establishes a large, diverse, prospective, longitudinal, multi-center cohort of children with history of SARS-CoV-2 infection compared to an uninfected cohort to be followed for 3 years. Cross-sectional cohort analysis at study entry showed infected participants were more likely to report constitutional, respiratory, and GI symptoms compared to uninfected controls. Infected participants were more likely to have significantly worse parent-reported performance in 6 of 10 Patient Reported Outcome Measures domains. Continued study of this cohort will help identify clinical sequelae of COVID-19, characterize the immune response to SARS-CoV-2 infection, and identify potential genetic/immunologic factors associated with long-term outcomes.

Fig. 1. Consort diagram - enrollment summary through June 30, 2023.

Flow chart of overall enrollment from July 19, 2021, to June 30, 2023, and flow chart distribution of acute COVID-19 illness and MIS-C cases among infected participants. Baseline visits completed after July 1, 2023, are not included in this report. COVID-19 Coronavirus Disease 2019, MIS-C Multisystem Inflammatory Syndrome in Children, PICU Pediatric Intensive Care Unit.

Fig. 2. Comparison of review of systems by symptoms in infected and uninfected.

Percentage of participants reporting symptoms since recovery of SARS-CoV-2 infection (infected) or since 2020 (uninfected), with odds ratio reporting the odds of infected participants reporting symptoms comparing to uninfected. P-values comparing odds of the findings between infected and uninfected are adjusted for age and sex. Generalized estimating equations (GEE) are used to account for correlation between family members participating in the study. CI Confidence Interval, HEENT head, ear, nose, and throat, GI gastrointestinal, GU genitourinary, Inf infinitive.

Fig. 3. Frequency of new diagnosis in infected (Post-COVID) and uninfected (After January 1, 2020).

Medical Dictionary for Regulatory Activities (MedDRA) coding was used for standardization and organ system grouping. SARS-CoV-2 re-infections were excluded from the infections and infestations organ group. MedDRA Categories related to injuries, and investigations are not shown here.