Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal
Kelli N O'Laughlin1,2, Matthew Thompson3, Bala Hota4
1Department of Emergency Medicine, University of Washington, Seattle, WA, United States of America.
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.
Insights
The INSPIRE study tracks long-term health effects of SARS-CoV-2 infection, comparing outcomes in infected versus uninfected individuals to identify risk factors for post-COVID conditions.
Area of Science:
- Infectious Diseases
- Epidemiology
- Public Health
Background:
- Limited data exists on the incidence and relative risk of medium- and long-term sequelae following SARS-CoV-2 infection.
- The Innovative Support for Patients with SARS-CoV-2 Registry (INSPIRE) was established to address this knowledge gap.
Purpose of the Study:
- To quantify the incidence and relative risk of medium- and long-term sequelae after SARS-CoV-2 infection.
- To identify predictors of these sequelae.
- To compare outcomes between SARS-CoV-2 positive and negative individuals with similar symptoms.
Main Methods:
- Prospective, multicenter, longitudinal study enrolling 4,800 participants across eight US regions.
- Combines patient-reported outcomes (surveys) with digital health records.
- Follow-up for up to 18 months, collecting data every three months.
Main Results:
- Enrollment and follow-up are ongoing.
- Data collection includes self-reported health status, function, health system encounters, and new diagnoses.
- A comparison group of SARS-CoV-2 negative participants is included.
Conclusions:
- This study will characterize medium- and long-term health consequences of SARS-CoV-2 infection.
- Findings will inform clinical interventions for individuals experiencing post-COVID conditions.
- Relative risk of sequelae will be assessed compared to a symptomatic, uninfected control group.
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