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

Active, not recruiting

• Conditions: SARS COV2; Neurocognitive Disorders; Cardiovascular Diseases; Covid19; ME/CFS; Novel Coronavirus Infection

• Registration Number: NCT04610515
• Lead Sponsor: Rush University Medical Center

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.

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 Timeline

• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-10-30
• Study Start: 2020-12-15
• Primary Completion: 2024-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Hospitalizations post enrollment	18 months post enrollment	Count of hospitalizations post enrollment as obtained from the EMR
ICU-free survival	18 months post enrollment	ICU-free survival as determined by data from the EMR
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.
Death during hospital admission	18 months post enrollment	Death during hospital admission as determined by data from the EMR
Hospital-free survival	18 months post enrollment	Hospital-free survival as determined by data from the EMR

Trial Locations

Locations (8)

University of Washington; 🇺🇸 Seattle, Washington, United States

Yale; 🇺🇸 New Haven, Connecticut, United States

UCLA; 🇺🇸 Los Angeles, California, United States

UCSF; 🇺🇸 San Francisco, California, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States