dbGaP Study Accession: phs002781
NIH Institute/Center: NICHD
RADx Data Program: RADx-rad
DOI: 10.60773/8yrw-qt94
Release Date: 07/21/2022
Study Description: SARS-CoV-2 infection exhibits a wide range of clinical outcomes in both children and adults, from asymptomatic and mild disease to severe viral pneumonia, ARDS, acute kidney injury, thrombotic disorders, and serious cardiac, cerebrovascular and vascular complications. It is now known that severe infection can occur both in young children and young adults (<21) and that nearly 40% of those who are admitted Covid-19 require ICU support, including mechanical ventilation. One of the most severe manifestations of SARS-CoV-2 infection is the multisystem inflammatory syndrome in children (MIS-C), a serious condition associated with severe inflammation with multi-organ involvement that can result in a variety of clinical presentations including pneumonia, sepsis, coagulation abnormalities, and renal/kidney failure. Thus, novel approaches for early and accurate diagnosis of COVID-19 associated syndromes and evaluation of clinical severity and outcomes of COVID-19 disease in children were urgently needed. This study identified RNA transcriptomic and cell-free DNA omics biomarkers that were used to develop and validate host-based assays from nasal swab and blood samples, with the goal of regulatory submission for FDA Emergency Use Authorization (EUA).
Updated Date: 01/18/2024
Principal Investigator: Chiu, Charles Yen
Has Data Files: Yes
Study Domain: Multisystem Inflammatory Syndrome (MIS); Diagnostic Testing; Medical Device/Tool Development; Multisystem Inflammatory Syndrome in Children (MIS-C)
Data Collection Method: Molecular (Nucleic Acid/PCR) Testing Device
Keywords: Pediatric; RNA Transcriptomic and Cell-free DNA Omics Biomarkers
Study Design: Longitudinal Cohort
Multi-Center Study: TRUE
Study Sites: Emory University; Children's National Research Institute; Cornell University
Data Types: Electronic Medical Records; Clinical; Genomic; Imaging; Individual Sequencing; Metagenomic; Questionnaires/Surveys
Study Start Date: 01/01/2021
Study End Date: 11/30/2022
Species: Non-Human Data; Human Data
Estimated Cohort Size: 800
Study Population Focus: Children; Adults
Publication URL: https://pubmed.ncbi.nlm.nih.gov/33521749/; https://pubmed.ncbi.nlm.nih.gov/34889874/; https://pubmed.ncbi.nlm.nih.gov/35396471/; https://pubmed.ncbi.nlm.nih.gov/36134603/; https://pubmed.ncbi.nlm.nih.gov/37279751/; https://pubmed.ncbi.nlm.nih.gov/34348808/
Acknowledgement Statement: This study was supported through funding, 4R61HD105618-02, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-rad program. We would like to acknowledge our collaborators who made subjects and samples available to this dataset: University of California, San Francisco (Drs. Charles Chiu, Charlotte Hsieh, and Theodore Ruel) Children’s Hospital of Atlanta / Emory University (Dr. Christina Rostad) Children’s National Medical Center (Drs. Roberta DeBiasi and Meghan Delaney). We acknowledge support from PIs Chiu, De Vlaminck, Rostad, and DeBiasi and from the US Centers for Disease Control and Prevention (CDC) (contract 75D30121C10991 to Chiu, PI). Approved users should acknowledge the provision of data access by dbGaP for accession phs002781.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.
Funding Opportunity Announcement (FOA) Number: RFA-OD-20-023
NIH Grant or Contract Number(s): 4R61HD105618-02
Consent/Data Use Limitations: General Research Use