Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection

Kelli N. O'Laughlin, Matthew Thompson, Bala Hota, Michael Gottlieb, Ian D. Plumb, Anna Marie Chang, Lauren E. Wisk, Aron J. Hall, Ralph C. Wang, Erica S. Spatz, Kari A. Stephens, Ryan M. Huebinger, Samuel A. McDonald, Arjun Venkatesh, Nikki Gentile, Benjamin H. Slovis, Mandy Hill, Sharon Saydah, Ahamed H. Idris, Robert RodriguezHarlan M. Krumholz, Joann G. Elmore, Robert A. Weinstein, Graham Nichol

Research output: Contribution to journalArticlepeer-review

Abstract

Background Reports on medium and long-term sequelae of SARS-CoV-2 infections largely lack quantification of incidence and relative risk. We describe the rationale and methods of the Innovative Support for Patients with SARS-CoV-2 Registry (INSPIRE) that combines patientreported outcomes with data from digital health records to understand predictors and impacts of SARS-CoV-2 infection. Methods INSPIRE is a prospective, multicenter, longitudinal study of individuals with symptoms of SARS-CoV-2 infection in eight regions across the US. Adults are eligible for enrollment if they are fluent in English or Spanish, reported symptoms suggestive of acute SARS-CoV-2 infection, and if they are within 42 days of having a SARS-CoV-2 viral test (i.e., nucleic acid amplification test or antigen test), regardless of test results. Recruitment occurs in-person, by phone or email, and through online advertisement. A secure online platform is used to facilitate the collation of consent-related materials, digital health records, and responses to self-administered surveys. Participants are followed for up to 18 months, with patientreported outcomes collected every three months via survey and linked to concurrent digital health data; follow-up includes no in-person involvement. Our planned enrollment is 4,800 participants, including 2,400 SARS-CoV-2 positive and 2,400 SARS-CoV-2 negative participants (as a concurrent comparison group). These data will allow assessment of longitudinal outcomes from SARS-CoV-2 infection and comparison of the relative risk of outcomes in individuals with and without infection. Patient-reported outcomes include self-reported health function and status, as well as clinical outcomes including health system encounters and new diagnoses. Results Participating sites obtained institutional review board approval. Enrollment and follow-up are ongoing. Conclusions This study will characterize medium and long-term sequelae of SARS-CoV-2 infection among a diverse population, predictors of sequelae, and their relative risk compared to persons with similar symptomatology but without SARS-CoV-2 infection. These data may inform clinical interventions for individuals with sequelae of SARS-CoV-2 infection.

Original languageEnglish (US)
Article numbere0264260
JournalPloS one
Volume17
Issue number3 March
DOIs
StatePublished - Mar 2022

ASJC Scopus subject areas

  • General

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