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| Name | Class |
|---|---|
| Yale University | OTHER |
| University of Washington | OTHER |
| Thomas Jefferson University | OTHER |
| University of California, Los Angeles |
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The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) study is a CDC-funded COVID-19 project to understand the long-term health outcomes in recently tested adults, both negative and positive, who have suspected COVID symptoms at the time of their test. Participants will complete short online surveys every 3 months for 18 months, share information about their health using a secure web-based platform, and are compensated for their time.
This study will use a digital platform to longitudinally track comprehensive information including patient self-report as well as data that describe the process and outcome of care in the electronic medical record (EMR) of a large representative sample of patients under investigation for SARSCOV2. The objective is to generate knowledge rapidly using digital tools and collaborative sciences to produce real-time data, analysis, and reporting compared to more traditional approaches. An additional goal is to promote an open science approach whereby scientists, with proper approvals and in line with the permissions granted by the participants, have the opportunity to work with data in ways that protect individual privacy but promote rapid dissemination and implementation of knowledge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic Individuals with infection with SARS-COV2 (ie exposed cohort) | Symptomatic Individuals test positive for SARS-COV2. Participants will be enrolled soon after infection and followed to assess for long term outcomes. | ||
| Symptomatic Individuals without infection with SARS-COV2 (ie unexposed cohort) | Symptomatic Individuals test negative for SARS-COV2. Participants will be enrolled soon after testing and followed to assess for long term outcomes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess for medium and long-term sequalae of SARS-CoV-2 infection | Clinical phenotypes of sequelae will be determined at the time of analysis based on published literature | 18 months post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) | Determine the risk of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in those with symptoms of SARSCOV2 infection with vs. without a positive confirmatory test. | 18 months post enrollment |
| Ambulatory care and/or ED visits post enrollment |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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Adults aged>=18, with symptoms consistent with infection with SARS-COV2; test positive vs test negative individuals will be enrolled at a rate of 3:1.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gottlieb, MD | Rush University Medical Center | Principal Investigator |
| Robert A Weinstein, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90024 | United States | ||
| UCSF |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42276798 | Derived | Burrola-Mendez Y, Lin E, Parrish C, Hsu C, Hill MJ, Gottlieb M, Rising KL, Wisk LE, Gentile NL, Geyer RE, Weinstein RA, Santangelo M, Gatling K, Dyal JW, Elmore JG, Rodriguez RM, Watts P, Chen J, Diao Z, Spatz ES, Chan KC, Stephens KA, O'Laughlin KN; INSPIRE Group. Identifying social determinants of health subgroups and their associations with health outcomes in a prospective US adult COVID-19 cohort: an analysis of the INSPIRE registry. BMJ Open. 2026 Jun 11;16(6):e105749. doi: 10.1136/bmjopen-2025-105749. | |
| 41566432 |
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| OTHER |
| University of California, San Francisco | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
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Count of ambulatory care and/or ED visits post enrollment as obtained from the EMR |
| 18 months post enrollment |
| Hospitalizations post enrollment | Count of hospitalizations post enrollment as obtained from the EMR | 18 months post enrollment |
| Death during hospital admission | Death during hospital admission as determined by data from the EMR | 18 months post enrollment |
| Hospital-free survival | Hospital-free survival as determined by data from the EMR | 18 months post enrollment |
| ICU-free survival | ICU-free survival as determined by data from the EMR | 18 months post enrollment |
| San Francisco |
| California |
| 94110 |
| United States |
| Yale | New Haven | Connecticut | 06510 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| Derived |
| Gottlieb M, Yu H, Chen J, Spatz ES, Gentile NL, Geyer RE, Santangelo M, Malicki C, Gatling K, O'Laughlin KN, Stephens KA, Elmore JG, Wisk LE, L'Hommedieu M, Rodriguez RM, Montoy JCC, Wang RC, Rising KL, Kean E, Dyal JW, Hill MJ, Venkatesh AK, Weinstein RA; INSPIRE Group. Obesity and Long COVID: intersecting epidemics? BMC Public Health. 2026 Jan 22;26(1):626. doi: 10.1186/s12889-025-26134-1. |
| 40496983 | Derived | Wisk LE, Gottlieb M, Chen P, Yu H, O'Laughlin KN, Stephens KA, Nichol G, Montoy JCC, Rodriguez RM, Santangelo M, Gatling K, Spatz ES, Venkatesh AK, Rising KL, Hill MJ, Huebinger R, Idris AH, Willis M, Kean E, McDonald SA, Elmore JG, Weinstein RA. Association of SARS-CoV-2 With Health-related Quality of Life 1 Year After Illness Using Latent Transition Analysis. Open Forum Infect Dis. 2025 Jun 10;12(6):ofaf278. doi: 10.1093/ofid/ofaf278. eCollection 2025 Jun. |
| 39172356 | Derived | Hill MJ, Huebinger RM, Ebna Mannan I, Yu H, Wisk LE, O'Laughlin KN, Gentile NL, Stephens KA, Gottlieb M, Weinstein RA, Koo K, Santangelo M, Saydah S, Spatz ES, Lin Z, Schaeffer K, Kean E, Montoy JCC, Rodriguez RM, Idris AH, McDonald S, Elmore JG, Venkatesh A. Race, Ethnicity, and Gender Differences in Patient Reported Well-Being and Cognitive Functioning Within 3 Months of Symptomatic Illness During COVID-19 Pandemic. J Racial Ethn Health Disparities. 2025 Oct;12(5):3192-3209. doi: 10.1007/s40615-024-02124-8. Epub 2024 Aug 22. |
| 37426952 | Derived | 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 KN, Plumb ID, Rising KL, Santangelo M, Saydah S, Wang RC, Venkatesh A, Stephens KA, Weinstein RA; INSPIRE Group. Long COVID Clinical Phenotypes up to 6 Months After Infection Identified by Latent Class Analysis of Self-Reported Symptoms. Open Forum Infect Dis. 2023 May 31;10(7):ofad277. doi: 10.1093/ofid/ofad277. eCollection 2023 Jul. |
| 37426947 | Derived | Wang RC, Gottlieb M, Montoy JCC, Rodriguez RM, Yu H, Spatz ES, Chandler CW, Elmore JG, Hannikainen PA, Chang AM, Hill M, Huebinger RM, Idris AH, Koo K, Li SX, McDonald S, Nichol G, O'Laughlin KN, Plumb ID, Santangelo M, Saydah S, Stephens KA, Venkatesh AK, Weinstein RA; 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 Infect Dis. 2023 May 23;10(7):ofad275. doi: 10.1093/ofid/ofad275. eCollection 2023 Jul. |
| 36705268 | Derived | Gottlieb M, Wang RC, Yu H, Spatz ES, Montoy JCC, Rodriguez RM, 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; Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE) Group. Severe Fatigue and Persistent Symptoms at 3 Months Following Severe Acute Respiratory Syndrome Coronavirus 2 Infections During the Pre-Delta, Delta, and Omicron Time Periods: A Multicenter Prospective Cohort Study. Clin Infect Dis. 2023 Jun 8;76(11):1930-1941. doi: 10.1093/cid/ciad045. |
| 36573005 | Derived | 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 RM, 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 Severe Acute Respiratory Syndrome Coronavirus 2 Tests: A Prospective Cohort Study From the INSPIRE Group. Clin Infect Dis. 2023 May 3;76(9):1559-1566. doi: 10.1093/cid/ciac966. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D015673 | Fatigue Syndrome, Chronic |
| D019965 | Neurocognitive Disorders |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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