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

Cardiovascular Diseases Clinical Trial

— INSPIRE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04610515
• Other study ID #: 75D30120C08008
• Status: Active, not recruiting
• Start date: December 15, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Communicable Diseases
• Coronavirus Infections
• COVID-19
• Covid19
• Infections
• ME/CFS
• Neurocognitive Disorders
• Novel Coronavirus Infection
• SARS COV2

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Texas Southwestern	Dallas	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	UCLA	Los Angeles	California
United States	Yale	New Haven	Connecticut
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	UCSF	San Francisco	California
United States	University of Washington	Seattle	Washington

Sponsors (8)

Lead Sponsor	Collaborator
Rush University Medical Center	The University of Texas Health Science Center, Houston, Thomas Jefferson University, University of California, Los Angeles, University of California, San Francisco, University of Texas Southwestern Medical Center, University of Washington, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	18 months post enrollment
Secondary	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.	18 months post enrollment
Secondary	Ambulatory care and/or ED visits post enrollment	Count of ambulatory care and/or ED visits post enrollment as obtained from the EMR	18 months post enrollment
Secondary	Hospitalizations post enrollment	Count of hospitalizations post enrollment as obtained from the EMR	18 months post enrollment
Secondary	Death during hospital admission	Death during hospital admission as determined by data from the EMR	18 months post enrollment
Secondary	Hospital-free survival	Hospital-free survival as determined by data from the EMR	18 months post enrollment
Secondary	ICU-free survival	ICU-free survival as determined by data from the EMR	18 months post enrollment