Innovative Support for Patients with SARS COV-2 Infections Registry
Hugo Health is participating in a national collaboration to determine the longitudinal effects of SARSCOV2 among patients who have exhibited symptoms of coronavirus and have been tested within the last month. This collaborative seeks to conduct urgently-needed applied research in a large representative sample of the United States population to address the COVID-19 public health emergency.
Looking for information about participating in this study? Visit the INSPIRE home page.
Aim 1: Determine the longitudinal outcomes of SARS COV-2 infections among different age groups in the US population. Our outcomes include healthcare utilization, clinical events, and physical and mental function and status, including neurocognitive function and fatigue. We will also describe outcomes by age of a sample of patients testing negative for SARS COV-2 who will serve as concurrent controls for those who test positive. We will follow participants for up to 18 months and repeatedly measure outcomes.
Aim 2: Determine the independent association of age with outcomes after adjustment for sex, race/ethnicity, presence of specific underlying conditions (e.g. hypertension and diabetes), and other characteristics identified in Aim 1.
Testing positive, across outpatient (including ED) and inpatient (including ICU)
In the analytic phase, will establish cohorts based on clinical severity and assess risks of of outcomes
We will enroll a total of 3600 cases and 1200 controls
We will use the Hugo platform to provide electronic informed consent, connect to EHR data and other data sources, and collect Patient Reported Outcome Measures (PROMs)
Clinical severity for COVID-19 will be defined between mild, moderate, and severe disease
testing positive but without symptoms or with mild symptoms and no functional limitations;
testing positive and requiring hospitalization but not ICU stay; and
testing positive and requiring an ICU stay (with or without the need for mechanical ventilation)
Will assess unadjusted and adjusted incidence/risk of outcomes in these cohorts vs. comparators
Aim 1 analyses:
Describe prevalence and distribution of symptom type, duration, severity and recovery among participants with SARS-CoV-2 by age (eg.<50 years vs 50-65 years vs >65 years)
Compare health status at baseline and follow-up between persons in the same age group who test SARS-CoV-2 positive and negative at initial test
Characterize health care utilization (ED visits, hospitalizations, post-acute care, telehealth visits) among SARS-CoV-2 positive participants by age
Characterize health outcomes by age and SARS-CoV-2 positive status: emergency or ambulatory care, admission to hospital); ICU-free survival; hospital-free survival; clinical events including need for intensive care, need for ventilation, onset of pneumonia or acute respiratory distress syndrome, myocardial infarction, renal failure, treated cardiac arrest, and death; and subsequent patient-reported health status (physical health; mental health; cognition; return to activities/work; ME-CFS)
Analyses to address Aim 2 will evaluate the independent effect of age on the outcomes examined in Aim 1 when also adjusted for additional patient level factors of interest, including gender, race/ethnicity, income, and presence of specific underlying conditions such as hypertension and diabetes, and other factors based on clinical experience.
We will use statistical modeling to estimate the association between age, and its interaction with key covariates, and outcomes. Survival analysis techniques will be used to analyze time to event outcomes. For binary outcomes (e.g., hospitalization/no hospitalization), we will use logistic regression. For continuous outcomes (e.g., PROMIS-29), we will use linear regression models.