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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04610515 |
Recruitment Status :
Recruiting
First Posted : October 30, 2020
Last Update Posted : January 15, 2021
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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 : | 4800 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 : | November 14, 2022 |
Estimated Study Completion Date : | November 14, 2022 |

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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- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 28 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
Contact: Jacqueline Brown | 312-942-3350 | Jacqueline_Brown@rush.edu | |
Contact: Katherine Koo | Katherine_Koo@rush.edu |
United States, California | |
UCLA | Not yet recruiting |
Los Angeles, California, United States, 90024 | |
Contact: Annie Lee, PhD 213-221-9392 annielee@mednet.ucla.edu | |
Contact: Raul Moreno 310-794-2268 rjmoreno@mednet.ucla.edu | |
Principal Investigator: Joann Elmore, MD | |
Sub-Investigator: Doug Bell, MD, PhD | |
Sub-Investigator: Lauren Wisk, PhD | |
UCSF | Not yet recruiting |
San Francisco, California, United States, 94110 | |
Contact: Robin Kemball 415-509-9842 robin.kemball@ucsf.edu | |
Principal Investigator: Robert Rodriguez, MD | |
Sub-Investigator: Ralph Wang, MD | |
United States, Connecticut | |
Yale | Recruiting |
New Haven, Connecticut, United States, 06510 | |
Contact: Jeremy Kinsman jeremiah.kinsman@yale.edu | |
Principal Investigator: Arjun Venkatesh, MD, MBA, MHS | |
Principal Investigator: Erica Spatz, MD, MHS | |
Sub-Investigator: Harlan Krumholz, MD | |
Sub-Investigator: Shu-Xia Li, PhD | |
Sub-Investigator: Zhenqui Lin, PhD | |
United States, Illinois | |
Rush University Medical Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Michelle Santangelo Michelle_Santangelo@rush.edu | |
Principal Investigator: Michael Gottlieb, MD | |
United States, Pennsylvania | |
Thomas Jefferson University | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Grace Amadio 267-772-7350 grace.amadio@jefferson.edu | |
Contact: Nicole Renzi 215-684-9391 nicole.renzi@jefferson.edu | |
Principal Investigator: Anna Marie Chang, MD | |
United States, Texas | |
University of Texas Southwestern | Not yet recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Paula Arellano-Cruz 469-324-7892 paula.arellano-cruz@utsouthwestern.edu | |
Principal Investigator: Ahamed Idris, MD | |
University of Texas Health Science Center at Houston | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Contact: Elizabeth Vidales 832-860-7669 Elizabeth.Vidales@uth.tmc.edu | |
Principal Investigator: Henry Wang, MD | |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Victoria Lyon 505-660-9500 vlyon@uw.edu | |
Principal Investigator: Matthew Thompson, MD | |
Principal Investigator: Kelli O'Loughlin, MD | |
Principal Investigator: Graham Nichol, MD | |
Sub-Investigator: Nikki Gentile, MD | |
Sub-Investigator: Keith Jerome, MD |
Principal Investigator: | Bala Hota, MD | Rush University Medical Center | |
Principal Investigator: | Robert A Weinstein, MD | Rush University Medical Center |
Responsible Party: | Bala Hota, VP, Chief Analytics Officer, Rush University Medical Center |
ClinicalTrials.gov Identifier: | NCT04610515 |
Other Study ID Numbers: |
75D30120C08008 |
First Posted: | October 30, 2020 Key Record Dates |
Last Update Posted: | January 15, 2021 |
Last Verified: | January 2021 |
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 |
Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Cardiovascular Diseases Neurocognitive Disorders Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Mental Disorders |