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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19, ME/CFS, SARS COV2, Novel Coronavirus Infection, Neurocognitive Disorders, Cardiovascular Diseases

Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Fluent in English or Spanish; Age 18 and over; Self-reported symptoms suggestive of acute SARSCOV2 infection; 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 Unable to provide informed consent; Study team unable to confirm result of diagnostic test for SARSCOV2; Does not have access to a hand-held device or computer that would allow for digital participation in the study; Individuals who are prisoners while participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic Individuals with infection with SARS-COV2 (ie exposed cohort)<br>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)<br>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?
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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 |