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

NCT ID: NCT04610515

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-15

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Gottlieb

Associate Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Gottlieb, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Robert A Weinstein, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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UCLA

Los Angeles, California, United States

Site Status

UCSF

San Francisco, California, United States

Site Status

Yale

New Haven, Connecticut, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

University of Texas Southwestern

Dallas, Texas, United States

Site Status

University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40496983 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39172356 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37426952 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37426947 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36705268 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36573005 (View on PubMed)

Other Identifiers

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75D30120C08008

Identifier Type: -

Identifier Source: org_study_id