NCT04610515: INSPIRE

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

Completed Last updated 14 November 2025

What this trial tests

trial in Covid19 in 6,000 participants. Completed in 31 October 2025.

Timeline

15 December 2020

Primary endpoint
31 August 2024

31 October 2025

Quick facts

Lead sponsor	Rush University Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	6,000
Start date	15 December 2020
Primary completion	31 August 2024
Estimated completion	31 October 2025
Sites	8 locations across United States

Conditions studied

• Covid19 — all drugs for Covid19 →
• ME/CFS — all drugs for ME/CFS →
• SARS COV2 — all drugs for SARS COV2 →
• Novel Coronavirus Infection — all drugs for Novel Coronavirus Infection →

Sponsor

Rush University Medical Center

Who can join

18 and older, any sex, with Covid19 or ME/CFS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Gottlieb M, Wang RC, Yu H, Spatz ES, et al · · 2023 · cited 74× · PMID 36705268 · DOI 10.1093/cid/ciad045
2. Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection.
   O'Laughlin KN, Thompson M, Hota B, Gottlieb M, et al · · 2022 · cited 39× · PMID 35239680 · DOI 10.1371/journal.pone.0264260
3. Long COVID Clinical Phenotypes up to 6 Months After Infection Identified by Latent Class Analysis of Self-Reported Symptoms.
   Gottlieb M, Spatz ES, Yu H, Wisk LE, et al · · 2023 · cited 31× · PMID 37426952 · DOI 10.1093/ofid/ofad277
4. 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.
   Spatz ES, Gottlieb M, Wisk LE, Anderson J, et al · · 2023 · cited 24× · PMID 36573005 · DOI 10.1093/cid/ciac966
5. Differences in Long COVID severity by duration of illness, symptom evolution, and vaccination: a longitudinal cohort study from the INSPIRE group.
   Gottlieb M, Yu H, Chen J, Spatz ES, et al · · 2025 · cited 16× · PMID 40040820 · DOI 10.1016/j.lana.2025.101026
6. 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.
   Wang RC, Gottlieb M, Montoy JCC, Rodriguez RM, et al · · 2023 · cited 14× · PMID 37426947 · DOI 10.1093/ofid/ofad275
7. Characteristics of patients referred to a cardiovascular disease clinic for post-acute sequelae of SARS-CoV-2 infection.
   Wang SY, Adejumo P, See C, Onuma OK, et al · · 2022 · cited 12× · PMID 35856065 · DOI 10.1016/j.ahjo.2022.100176
8. Association of SARS-CoV-2 With Health-related Quality of Life 1 Year After Illness Using Latent Transition Analysis.
   Wisk LE, Gottlieb M, Chen P, Yu H, et al · · 2025 · cited 7× · PMID 40496983 · DOI 10.1093/ofid/ofaf278