Cellular Senescence and COVID-19 Long-Hauler Syndrome

NCT04903132 | Active Not Recruiting

• 1 other identifier: 20-011877
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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 -
• 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.
• 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
• Ability to give informed consent.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples from subjects might include a blood (50 mL) specimen and urine specimen, which would be held and stored for future use.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ryan T. Hurt, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 26, 2021
• Study Start: March 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)