PLoS ONE (Jan 2022)

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 Rodriguez,
  • Harlan M. Krumholz,
  • Joann G. Elmore,
  • Robert A. Weinstein,
  • Graham Nichol,
  • for the INSPIRE Investigators

Journal volume & issue
Vol. 17, no. 3

Abstract

Read online

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 patient-reported 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 patient-reported 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.