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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04610515
Recruitment Status : Active, not recruiting
First Posted : October 30, 2020
Last Update Posted : September 2, 2022
Sponsor:
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
Information provided by (Responsible Party):
Michael Gottlieb, Rush University Medical Center

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

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE)
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Assess for medium and long-term sequalae of SARS-CoV-2 infection [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 18 months post enrollment ]
    Count of ambulatory care and/or ED visits post enrollment as obtained from the EMR

  3. Hospitalizations post enrollment [ Time Frame: 18 months post enrollment ]
    Count of hospitalizations post enrollment as obtained from the EMR

  4. Death during hospital admission [ Time Frame: 18 months post enrollment ]
    Death during hospital admission as determined by data from the EMR

  5. Hospital-free survival [ Time Frame: 18 months post enrollment ]
    Hospital-free survival as determined by data from the EMR

  6. ICU-free survival [ Time Frame: 18 months post enrollment ]
    ICU-free survival as determined by data from the EMR


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610515


Locations
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United States, California
UCLA
Los Angeles, California, United States, 90024
UCSF
San Francisco, California, United States, 94110
United States, Connecticut
Yale
New Haven, Connecticut, United States, 06510
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Washington
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
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Principal Investigator: Michael Gottlieb, MD Rush University Medical Center
Principal Investigator: Robert A Weinstein, MD Rush University Medical Center
More Information
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Responsible Party: Michael Gottlieb, Associate Professor of Emergency Medicine, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04610515    
Other Study ID Numbers: 75D30120C08008
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Cardiovascular Diseases
Neurocognitive Disorders
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
 Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Mental Disorders