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CompletedNCT04610515INSPIREUpdated Nov 14, 2025

Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE)

An observational study in Covid19, ME/CFS and SARS COV2, sponsored by Rush University Medical Center. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-14.

Sponsored by Rush University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,000
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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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Conditions studied

  • Covid19
  • ME/CFS
  • SARS COV2
  • Novel Coronavirus Infection
  • Neurocognitive Disorders
  • Cardiovascular Diseases
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 6,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  1. Fluent in English or Spanish;
  2. Age 18 and over;
  3. Self-reported symptoms suggestive of acute SARSCOV2 infection;
  4. Under investigation for SARSCOV2 (defined as a patient who has received any screening or diagnostic test used to detect the presence of COVID19 including any FDA approved or authorized molecular or antigen-based assay) within the last 42 days.

Exclusion criteria

EXCLUSION CRITERIA

  1. Unable to provide informed consent;
  2. Study team unable to confirm result of diagnostic test for SARSCOV2;
  3. Does not have access to a hand-held device or computer that would allow for digital participation in the study;
  4. Individuals who are prisoners while participating in the study.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,000 participants (actual)
Target follow-up
18 Months
Patient registry
Yes

Groups and cohorts

  • 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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What researchers measure

Primary outcomes

  1. 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

    Time frame: 18 months post enrollment

Secondary outcomes

  1. 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.

    Time frame: 18 months post enrollment

  2. Ambulatory care and/or ED visits post enrollment

    Count of ambulatory care and/or ED visits post enrollment as obtained from the EMR

    Time frame: 18 months post enrollment

  3. Hospitalizations post enrollment

    Count of hospitalizations post enrollment as obtained from the EMR

    Time frame: 18 months post enrollment

  4. Death during hospital admission

    Death during hospital admission as determined by data from the EMR

    Time frame: 18 months post enrollment

  5. Hospital-free survival

    Hospital-free survival as determined by data from the EMR

    Time frame: 18 months post enrollment

  6. ICU-free survival

    ICU-free survival as determined by data from the EMR

    Time frame: 18 months post enrollment

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Study locations

8 sites
  • UCLA
    Los Angeles, California 90024, United States
  • UCSF
    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
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References and documents

Publications

  • 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. PubMed 42276798 ↗
  • 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. PubMed 41566432 ↗
  • Openshaw JJ, Chen J, Rodriguez R, Gottlieb M, McCullough K, Santangelo M, Hill MJ, Gatling K, Idris AH, McDonald S, Wisk LE, Dyal J, Wang RC, Rising KL, Kean E, O'Laughlin KN, Stephens KA, Malicki C, Lin Z, Spatz ES, Yu H, Weinstein RA, Elmore J. The Effect of SARS-CoV-2 Reinfection on Long-Term Symptoms in the Innovative Support for Patients With SARS-CoV-2 Infections Registry (INSPIRE). Clin Infect Dis. 2025 Oct 6;81(3):416-426. doi: 10.1093/cid/ciaf225. PubMed 40576557 ↗
  • 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. PubMed 40496983 ↗
  • 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. PubMed 39172356 ↗
  • 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. PubMed 37426952 ↗
  • 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. PubMed 37426947 ↗
  • 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. PubMed 36705268 ↗
  • 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. PubMed 36573005 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04610515
Lead sponsor
Rush University Medical Center
Collaborators
Yale University, University of Washington, Thomas Jefferson University, University of California, Los Angeles, University of California, San Francisco, University of Texas Southwestern Medical Center, The University of Texas Health Science Center, Houston
Responsible party
Michael Gottlieb (Associate Professor of Emergency Medicine, Rush University Medical Center) — Principal investigator
First posted
Oct 30, 2020
Start date
Dec 15, 2020
Primary completion
Aug 31, 2024
Completion
Oct 31, 2025
Last update
Nov 14, 2025

Study contacts

Michael Gottlieb, MD
principal investigator · Rush University Medical Center
Robert A Weinstein, MD
principal investigator · Rush University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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