Clinical trial NCT04610515: Innovative Support for Patients with SARS-COV2 Infections (COVID-19) Registry (INSPIRE)
Official title: Innovative Support for Patients with SARS-COV2 Infections (COVID-19) Registry (INSPIRE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
ME/CFS
SARS COV2
Novel Coronavirus Infection
Neurocognitive Disorders
Cardiovascular Diseases
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Yale University
name: University of Washington
name: Thomas Jefferson University
name: University of California, Los Angeles
name: University of California, San Francisco
name: University of Texas Southwestern Medical Center
name: The University of Texas Health Science Center, Houston
First posted: 2020-10-30
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Assess for medium and long-term sequalae of SARS-CoV-2 infection
timeFrame: 18 months post enrollment
Secondary outcomes:
measure: Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
timeFrame: 18 months post enrollment
measure: Ambulatory care and/or ED visits post enrollment
timeFrame: 18 months post enrollment
measure: Hospitalizations post enrollment
timeFrame: 18 months post enrollment
measure: Death during hospital admission
timeFrame: 18 months post enrollment
measure: Hospital-free survival
timeFrame: 18 months post enrollment
measure: ICU-free survival
timeFrame: 18 months post enrollment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: New Haven
country: United States
facility: Yale
state: Connecticut
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Rush University Medical Center
name: Michael Gottlieb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Robert A Weinstein, MD
role: PRINCIPAL_INVESTIGATOR
References: