Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE) (INSPIRE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04610515 |
Recruitment Status :
Active, not recruiting
First Posted : October 30, 2020
Last Update Posted : September 2, 2022
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Condition or disease |
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Covid19 ME/CFS SARS COV2 Novel Coronavirus Infection Neurocognitive Disorders Cardiovascular Diseases |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 6000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 18 Months |
Official Title: | Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE) |
Actual Study Start Date : | December 15, 2020 |
Estimated Primary Completion Date : | March 31, 2023 |
Estimated Study Completion Date : | March 31, 2023 |

Group/Cohort |
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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.
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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.
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- 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
- 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.
- 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
- Hospitalizations post enrollment [ Time Frame: 18 months post enrollment ]Count of hospitalizations post enrollment as obtained from the EMR
- Death during hospital admission [ Time Frame: 18 months post enrollment ]Death during hospital admission as determined by data from the EMR
- Hospital-free survival [ Time Frame: 18 months post enrollment ]Hospital-free survival as determined by data from the EMR
- ICU-free survival [ Time Frame: 18 months post enrollment ]ICU-free survival as determined by data from the EMR

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610515
United States, California | |
UCLA | |
Los Angeles, California, United States, 90024 | |
UCSF | |
San Francisco, California, United States, 94110 | |
United States, Connecticut | |
Yale | |
New Haven, Connecticut, United States, 06510 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Pennsylvania | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
University of Texas Southwestern | |
Dallas, Texas, United States, 75390 | |
University of Texas Health Science Center at Houston | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98104 |
Principal Investigator: | Michael Gottlieb, MD | Rush University Medical Center | |
Principal Investigator: | Robert A Weinstein, MD | Rush University Medical Center |
Responsible Party: | Michael Gottlieb, Associate Professor of Emergency Medicine, Rush University Medical Center |
ClinicalTrials.gov Identifier: | NCT04610515 |
Other Study ID Numbers: |
75D30120C08008 |
First Posted: | October 30, 2020 Key Record Dates |
Last Update Posted: | September 2, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infections Communicable Diseases COVID-19 Coronavirus Infections Cardiovascular Diseases Neurocognitive Disorders Disease Attributes Pathologic Processes Respiratory Tract Infections |
Pneumonia, Viral Pneumonia Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Mental Disorders |