INSPIRE
Innovative Support For Patients with SARS COV-2 Infections Registry
Project Summary:
The INSPIRE study is a multi-institutional, longitudinal cohort study that focuses on the association of age and other vulnerabilities with clinical outcomes and patient-reported outcomes in people infected with the coronavirus illness (COVID-19) as well as a concurrent control group who were under investigation but tested negative. This study is designed to expand the knowledge base related to this infection, and produce results that: are expected to be applicable to a larger population beyond the site of data collection or the specific subjects studied.
Population:
Adults, age 18 or older, who have experienced symptoms of COVID-19 and have been tested within the last 4 weeks. Enrollment will take place from two populations: seeking testing but having a negative result and testing positive, across outpatient (including ED) and inpatient (including ICU). A total of 4800 subjects will be enrolled with 3600 active and 1200 controls.
Outcomes:
Patient-reported outcomes include self-reported health function and status, as well as clinical outcomes including health system encounters and new diagnoses.
Enrollment:
3,830 total enrolled as of 2/17/22
Study Team:
Mandy Hill, DrPH, MPH (Principal Investigator) | Jonathan Dyal, MD, MPH (Co-Investigator) | Arun Kane (Research Coordinator) | Akeria Taylor, MPH (Research Coordinator)
Dissemination:
Preprint manuscripts:
Hill. M and Huebinger, R, 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. MedRxiv. 22. DOI: 10.1101/2021.08.01.21261397.
Publications:
O’Laughlin, K., Chi, G., Thompson, M., Hota, B., Gottlieb, M., Plumb, I, Change, A., Wisk, L., Hall, A., Wang, R., Spatz, E., Stephens, K., Huebinger, R., McDonald, S., Venkatesh, A., Gentile, N., Slovis, B., Hill, M., Saydah, S., Idris, A., Rodriguez, R., Krumholz, K., Elmore, J., Weinstein, R., and Nichol, G. 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. PLOS One, medRxiv 2021.08.01.21261397; https://doi.org/10.1101/2021.08.01.21261397, 2022.
Wisk LE, Gottlieb MA, Spatz ES, Yu H, Wang RC, Slovis BH, Saydah S, Plumbhttps://doi.org/10.1101/2021.08.01.21261397 ID, O’Laughlin KN, Montoy JCC, McDonald SA, Lin Z, Lin JS, Koo K, Idris AH, Huebinger RM, Hill MJ, Gentile NL, Chang AM, Anderson J, Hota B, Venkatesh AK, Weinstein RA, Elmore JG, Nichol G; INSPIRE Group. Association of Initial SARS-CoV-2 Test Positivity With Patient-Reported Well-being 3 Months After a Symptomatic Illness. JAMA Netw Open. 2022 Dec 1;5(12):e2244486. doi: 10.1001/jamanetworkopen.2022.44486. PMID: 36454572; PMCID: PMC9716377.
Spatz ES, Gottlieb M, Wisk LE, Anderson J, Chang AM, Gentile NL, Hill MJ, Huebinger RM, Idris AH, Kinsman J, Koo K, Li SX, McDonald S, Plumb ID, Rodriguez R, Saydah S, Slovis B, Stephens KA, Unger ER, Wang RC, Yu H, Hota B, Elmore JG, Weinstein RA, Venkatesh A. Three-month symptom profiles among symptomatic adults with positive and negative SARS-CoV-2 tests: a prospective cohort study from the INSPIRE group. Clin Infect Dis. 2022 Dec 27:ciac966. doi: 10.1093/cid/ciac966. Epub ahead of print. PMID: 36573005.
Gottlieb M, Wang R, Yu H, Spatz ES, Montoy JC, Rodriguez R, Chang AM, Elmore JG, Hannikainen PA, Hill M, Huebinger RM, Idris AH, Lin Z, Koo K, McDonald S, O’Laughlin KN, Plumb ID, Santangelo M, Saydah S, Willis M, Wisk LE, Venkatesh A, Stephens KA, Weinstein RA; INSPIRE Group. Severe Fatigue and Persistent Symptoms at Three Months Following SARS-CoV-2 Infections During the Pre-Delta, Delta, and Omicron Time Periods: A Multicenter Prospective Cohort Study. Clin Infect Dis. 2023 Jan 27:ciad045. doi: 10.1093/cid/ciad045. Epub ahead of print. PMID: 36705268.
Gottlieb M, Spatz ES, Yu H, Wisk LE, Elmore JG, Gentile NL, Hill M, Huebinger RM, Idris AH, Kean ER, Koo K, Li SX, McDonald S, Montoy JCC, Nichol G, O’Laughlin K, Plumb ID, Rising KL, Santangelo M, Saydah S, Wang RC, Venkatesh A, Stephens KA, Weinstein RA; INSPIRE Group. Long COVID Clinical Phenotypes Up to Six Months After Infection Identified by Latent Class Analysis of Self-Reported Symptoms. Open Forum Infec Dis. Accepted: 5/8/23.
Ralph C Wang, Michael Gottlieb, Juan Carlos Montoy, Robert Rodriguez, Huihui Yu, Erica S Spatz, Christopher W Chandler, Joann G Elmore, Paavali A Hannikainen, Anna Marie Chang, Mandy Hill, Ryan M Huebinger, Ahamed H Idris, Katherine Koo, Shu-Xia Li, Samuel McDonald, Graham Nichol, Kelli O’Laughlin, Ian D Plumb, Michelle Santangelo, Sharon Saydah, Kari A Stephens, Arjun Venkatesh, Robert A Weinstein, For the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE) Group. Association between SARS-CoV-2 variants and frequency of acute symptoms: Analysis of a multi-institutional prospective cohort study – December 20, 2020 – June 20, 2022, Open Forum Infectious Diseases, 2023; ofad275, https://doi.org/10.1093/ofid/ofad275
Juan Carlos C Montoy, MD, PhD1; James Ford, MD1; Huihui Yu, PhD2,3; Michael Gottlieb, MD4; Dana Morse 5; Michelle Santangelo, MS6; Kelli N O’Laughlin, MD7,8; Kevin Schaeffer9; Pamela Logan, MD10; Kristin Rising, MD11,12; Mandy J Hill, DrPH13; Lauren E Wisk, PhD14; Wafah Salah15; Ahamed H Idris, MD16; Ryan M Huebinger, MD13; Erica Spatz, MD2,3; Robert M Rodriguez, MD1; Robin E Klabbers, MSc, MSc8; Kristyn Gatling, MA6; Ralph C Wang, MD1; Joann G Elmore, MD17,18; Samuel A McDonald, MD19,20; Kari A Stephens, PhD21,22; Robert A Weinstein, MD23,24; Arjun K Venkatesh, MD3,25; Sharon Saydah, PhD10; for the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE) Group26. 2023. Prevalence of symptoms up to one year following acute illness by COVID-19 testing status among adults — Innovative Support for Patients with SARS-CoV-2 Infections Registry, United States, December 2020–March 2023. MMWR, 72(32);859–865.
Funding and Collaborators:
Study Teams:
The INSPIRE study is an eight-center national project, in collaboration with Hugo Health, with Rush University as the lead research site.
Participating institutions include:
