NCT04610515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

November 14, 2025

Status Verified

July 1, 2025

Enrollment Period

3.7 years

First QC Date

October 28, 2020

Last Update Submit

November 12, 2025

Conditions

Covid19ME/CFSSARS COV2Novel Coronavirus InfectionNeurocognitive DisordersCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

    18 months post enrollment

  • Ambulatory care and/or ED visits post enrollment

    18 months post enrollment

  • Hospitalizations post enrollment

    18 months post enrollment

  • Death during hospital admission

    18 months post enrollment

  • Hospital-free survival

    18 months post enrollment

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UCLA

Los Angeles, California, 90024, United States

Location

UCSF

San Francisco, California, 94110, United States

Location

Yale

New Haven, Connecticut, 06510, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (6)

  • Wisk LE, Gottlieb M, Chen P, Yu H, O'Laughlin KN, Stephens KA, Nichol G, Montoy JCC, Rodriguez RM, Santangelo M, Gatling K, Spatz ES, Venkatesh AK, Rising KL, Hill MJ, Huebinger R, Idris AH, Willis M, Kean E, McDonald SA, Elmore JG, Weinstein RA. Association of SARS-CoV-2 With Health-related Quality of Life 1 Year After Illness Using Latent Transition Analysis. Open Forum Infect Dis. 2025 Jun 10;12(6):ofaf278. doi: 10.1093/ofid/ofaf278. eCollection 2025 Jun.

    PMID: 40496983DERIVED

  • Hill MJ, Huebinger RM, Ebna Mannan I, Yu H, Wisk LE, O'Laughlin KN, Gentile NL, Stephens KA, Gottlieb M, Weinstein RA, Koo K, Santangelo M, Saydah S, Spatz ES, Lin Z, Schaeffer K, Kean E, Montoy JCC, Rodriguez RM, Idris AH, McDonald S, Elmore JG, Venkatesh A. Race, Ethnicity, and Gender Differences in Patient Reported Well-Being and Cognitive Functioning Within 3 Months of Symptomatic Illness During COVID-19 Pandemic. J Racial Ethn Health Disparities. 2025 Oct;12(5):3192-3209. doi: 10.1007/s40615-024-02124-8. Epub 2024 Aug 22.

    PMID: 39172356DERIVED

  • Gottlieb M, Spatz ES, Yu H, Wisk LE, Elmore JG, Gentile NL, Hill M, Huebinger RM, Idris AH, Kean ER, Koo K, Li SX, McDonald S, Montoy JCC, Nichol G, O'Laughlin KN, Plumb ID, Rising KL, Santangelo M, Saydah S, Wang RC, Venkatesh A, Stephens KA, Weinstein RA; INSPIRE Group. Long COVID Clinical Phenotypes up to 6 Months After Infection Identified by Latent Class Analysis of Self-Reported Symptoms. Open Forum Infect Dis. 2023 May 31;10(7):ofad277. doi: 10.1093/ofid/ofad277. eCollection 2023 Jul.

    PMID: 37426952DERIVED

  • Wang RC, Gottlieb M, Montoy JCC, Rodriguez RM, Yu H, Spatz ES, Chandler CW, Elmore JG, Hannikainen PA, Chang AM, Hill M, Huebinger RM, Idris AH, Koo K, Li SX, McDonald S, Nichol G, O'Laughlin KN, Plumb ID, Santangelo M, Saydah S, Stephens KA, Venkatesh AK, Weinstein RA; Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE) Group. Association Between SARS-CoV-2 Variants and Frequency of Acute Symptoms: Analysis of a Multi-institutional Prospective Cohort Study-December 20, 2020-June 20, 2022. Open Forum Infect Dis. 2023 May 23;10(7):ofad275. doi: 10.1093/ofid/ofad275. eCollection 2023 Jul.

    PMID: 37426947DERIVED

  • Gottlieb M, Wang RC, Yu H, Spatz ES, Montoy JCC, Rodriguez RM, Chang AM, Elmore JG, Hannikainen PA, Hill M, Huebinger RM, Idris AH, Lin Z, Koo K, McDonald S, O'Laughlin KN, Plumb ID, Santangelo M, Saydah S, Willis M, Wisk LE, Venkatesh A, Stephens KA, Weinstein RA; Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE) Group. Severe Fatigue and Persistent Symptoms at 3 Months Following Severe Acute Respiratory Syndrome Coronavirus 2 Infections During the Pre-Delta, Delta, and Omicron Time Periods: A Multicenter Prospective Cohort Study. Clin Infect Dis. 2023 Jun 8;76(11):1930-1941. doi: 10.1093/cid/ciad045.

    PMID: 36705268DERIVED

  • Spatz ES, Gottlieb M, Wisk LE, Anderson J, Chang AM, Gentile NL, Hill MJ, Huebinger RM, Idris AH, Kinsman J, Koo K, Li SX, McDonald S, Plumb ID, Rodriguez RM, Saydah S, Slovis B, Stephens KA, Unger ER, Wang RC, Yu H, Hota B, Elmore JG, Weinstein RA, Venkatesh A. Three-Month Symptom Profiles Among Symptomatic Adults With Positive and Negative Severe Acute Respiratory Syndrome Coronavirus 2 Tests: A Prospective Cohort Study From the INSPIRE Group. Clin Infect Dis. 2023 May 3;76(9):1559-1566. doi: 10.1093/cid/ciac966.

    PMID: 36573005DERIVED

MeSH Terms

Conditions

COVID-19Fatigue Syndrome, ChronicNeurocognitive DisordersCardiovascular Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMuscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Michael Gottlieb, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

  • Robert A Weinstein, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Emergency Medicine

Study Record Dates

First Submitted

October 28, 2020

First Posted

October 30, 2020

Study Start

December 15, 2020

Primary Completion

August 31, 2024

Study Completion

October 31, 2025

Last Updated

November 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(8)