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Covid19INSPIRENCT04610515

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

An observational study of Covid19 and ME/CFS, run by Rush University Medical Center at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19, ME/CFS, SARS COV2
How many people
6,000 participants
Where
8 sitesUnited States
Study dates
15 Dec 2020to 31 Oct 2025
How long will I take part?
18 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • Fluent in English or Spanish;
  • Age 18 and over;
  • Self-reported symptoms suggestive of acute SARSCOV2 infection;
  • 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.

Who cannot join

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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • UCLA

    Los Angeles, California, 90024

  • Yale

    New Haven, Connecticut, 06510

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • UCSF

    San Francisco, California, 94110

  • University of Washington

    Seattle, Washington, 98104

Other trials in United States

About this study

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.

Medical subject headings
COVID-19, Fatigue Syndrome, Chronic, Neurocognitive Disorders, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04610515
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 18 months post enrollment

Secondary outcomes (6)

  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.

    Measured: 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

    Measured: 18 months post enrollment

  3. Hospitalizations post enrollment

    Count of hospitalizations post enrollment as obtained from the EMR

    Measured: 18 months post enrollment

  4. Death during hospital admission

    Death during hospital admission as determined by data from the EMR

    Measured: 18 months post enrollment

  5. Hospital-free survival

    Hospital-free survival as determined by data from the EMR

    Measured: 18 months post enrollment

  6. ICU-free survival

    ICU-free survival as determined by data from the EMR

    Measured: 18 months post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2020
  2. Study start15 Dec 2020
  3. Primary completion31 Aug 2024
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,000 participants (actual)
Target duration
18 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04610515
Sponsor's protocol ID
75D30120C08008
Acronym
INSPIRE
Status last verified
Jul 2025
First submitted
28 Oct 2020
Last updated
14 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and ME/CFS, run by Rush University Medical Center at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess for medium and long-term sequalae of SARS-CoV-2 infection (time frame: 18 months post enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04610515, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.

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