Skip to main content
OpenTrials
Completed

NCT Number: NCT04610515

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Cardiovascular Diseases Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Infections Lung Diseases ME/CFS Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurocognitive Disorders Neuroinflammatory Diseases Neuromuscular Diseases Nidovirales Infections Novel Coronavirus Infection Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS COV2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Assess for medium and long-term sequalae of SARS-CoV-2 infection

    Time frame: 18 months post enrollment

    Clinical phenotypes of sequelae will be determined at the time of analysis based on published literature

Secondary outcomes

  1. Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

    Time frame: 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.

  2. Ambulatory care and/or ED visits post enrollment

    Time frame: 18 months post enrollment

    Count of ambulatory care and/or ED visits post enrollment as obtained from the EMR

  3. Hospitalizations post enrollment

    Time frame: 18 months post enrollment

    Count of hospitalizations post enrollment as obtained from the EMR

  4. Death during hospital admission

    Time frame: 18 months post enrollment

    Death during hospital admission as determined by data from the EMR

  5. Hospital-free survival

    Time frame: 18 months post enrollment

    Hospital-free survival as determined by data from the EMR

  6. ICU-free survival

    Time frame: 18 months post enrollment

    ICU-free survival as determined by data from the EMR

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • 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

Registry information

Acronym: INSPIRE

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Oct 30, 2020
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.