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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Neurocognitive Disorders; Covid19; ME/CFS; Novel Coronavirus Infection; SARS COV2

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 Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • UCLA
    • San Francisco, California, United States, 94110
      • UCSF
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Hospitalizations post enrollment	Count of hospitalizations post enrollment as obtained from the EMR	18 months post enrollment
Death during hospital admission	Death during hospital admission as determined by data from the EMR	18 months post enrollment
Hospital-free survival	Hospital-free survival as determined by data from the EMR	18 months post enrollment
ICU-free survival	ICU-free survival as determined by data from the EMR	18 months post enrollment

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: The University of Texas Health Science Center, Houston; University of California, Los Angeles; Yale University; University of Washington; University of California, San Francisco; University of Texas Southwestern Medical Center; Thomas Jefferson University
• Investigators: Principal Investigator: Michael Gottlieb, MD, Rush University Medical Center; Principal Investigator: Robert A Weinstein, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Coronavirus Infections; Cardiovascular Diseases; Infections; Communicable Diseases; Neurocognitive Disorders
• Other Study ID Numbers: 75D30120C08008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No