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

Sponsor
Rush University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04610515
Collaborator
Yale University (Other), University of Washington (Other), Thomas Jefferson University (Other), University of California, Los Angeles (Other), University of California, San Francisco (Other), University of Texas Southwestern Medical Center (Other), The University of Texas Health Science Center, Houston (Other)
6,000
Enrollment
8
Locations
27.5
Anticipated Duration (Months)
750
Patients Per Site
27.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    6000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE)
    Actual Study Start Date :
    Dec 15, 2020
    Anticipated Primary Completion Date :
    Mar 31, 2023
    Anticipated Study Completion Date :
    Mar 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Assess for medium and long-term sequalae of SARS-CoV-2 infection [18 months post enrollment]

      Clinical phenotypes of sequelae will be determined at the time of analysis based on published literature

    Secondary Outcome Measures

    1. Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) [18 months post enrollment]

      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.

    2. Ambulatory care and/or ED visits post enrollment [18 months post enrollment]

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

    3. Hospitalizations post enrollment [18 months post enrollment]

      Count of hospitalizations post enrollment as obtained from the EMR

    4. Death during hospital admission [18 months post enrollment]

      Death during hospital admission as determined by data from the EMR

    5. Hospital-free survival [18 months post enrollment]

      Hospital-free survival as determined by data from the EMR

    6. ICU-free survival [18 months post enrollment]

      ICU-free survival as determined by data from the EMR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Los Angeles California United States 90024
    2 UCSF San Francisco California United States 94110
    3 Yale New Haven Connecticut United States 06510
    4 Rush University Medical Center Chicago Illinois United States 60612
    5 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    6 University of Texas Southwestern Dallas Texas United States 75390
    7 University of Texas Health Science Center at Houston Houston Texas United States 77030
    8 University of Washington Seattle Washington United States 98104

    Sponsors and Collaborators

    • Rush University Medical Center
    • 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

    Investigators

    • Principal Investigator: Michael Gottlieb, MD, Rush University Medical Center
    • Principal Investigator: Robert A Weinstein, MD, Rush University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Gottlieb, Associate Professor of Emergency Medicine, Rush University Medical Center
    ClinicalTrials.gov Identifier:
    NCT04610515
    Other Study ID Numbers:
    • 75D30120C08008
    First Posted:
    Oct 30, 2020
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    COVID-19
    Coronavirus Infections
    Cardiovascular Diseases
    Neurocognitive Disorders

    Study Results

    No Results Posted as of Jun 29, 2022