Cellular Senescence and COVID-19 Long-Hauler Syndrome

Cellular Senescence and Its Contribution to COVID-19 Long-Hauler Syndrome

The purpose of this study is to test if senescent cells and their secretome contribute to Long-Hauler Syndrome and if a clinical trial of senolytic drugs, which selectively eliminate senescent cells, should be initiated.

Study Overview

• Status: Active, not recruiting
• Conditions: SARS-CoV2 Infection

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Longhauler's Cohort: Patients must be at least 18 years or older, have a positive PCR or antibody test within six months, and report any ongoing symptoms associated with Post-COVID or Long-Haulers Syndrome.

Control Cohort: Patients must be at least 18 years or older, have not had a known case of COVID-19 or Longhauler's syndrome.

COVID Control Cohort: Patients must be at least 18 years or older and have had COVID-19 but no known Longhauler's syndrome.

Description

Longhauler's Cohort -

Inclusion Criteria:

• Ability to give informed consent or LAR.
• At least 18 years old.
• Ability of subject or LAR to read and speak the English language.
• Positive PCR or antibody test within 12 months of initial study visit.
• Patient of the Long-Hauler Syndrome clinic and differential diagnosis of Long-Hauler Syndrome.

Exclusion Criteria:

• Any potential participant who refuses medical record review.
• Pregnant females.
• Incarcerated individuals.
• Inability to cooperate or any medical condition that, in the opinion of the investigator, interferes with the evaluation of the study objectives or increases the subject's risk by participating in the study.

Control Cohort -

Inclusion Criteria:

• Ability to give informed consent
• At least 18 years old
• Ability of subject to read and speak the English language

Exclusion Criteria:

• Known case of COVID-19.
• Any potential participant who refuses medical record review.
• Pregnant females.
• Incarcerated individuals.
• Inability to cooperate or any medical condition that interferes with the evaluation of the study objectives or increases the subject's risk by participating in the study.

COVID-19 Control Cohort

Inclusion Criteria:

• Ability to give informed consent.
• At least 18 years old.
• Ability of subject to read and speak the English language.
• Known case of COVID-19.

Exclusion Criteria:

• Known Longhauler's syndrome/Post-COVID
• Any potential participant who refuses medical record review.
• Pregnant females.
• Incarcerated individuals.
• Inability to cooperate or any medical condition that interferes with the evaluation of the study objectives or increases the subject's risk by participating in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Longhauler's Syndrome Cohort; Subject's with longhaulers
Control Cohort; Control cohort will not have had a known case of COVID-19 or Longhauler's syndrome
COVID Control Cohort; Subjects who have had COVID-19 but no known Longhauler's syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between features of Long-Hauler Syndrome with markers of cellular senescence and SASP factors	If a correlation between features of Long-Hauler Syndrome with markers of cellular senescence and SASP factors can be demonstrated, or SASP factors are higher in Long-Hauler Syndrome clinic patients than age- and sex-matched controls (using archived samples) in this pilot study, a protocol will be submitted to the IRB for a trial in Long-Hauler Syndrome patients of senolytic drugs.	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ryan T. Hurt, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: 20-011877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No