Cellular Senescence and COVID-19 Long-Hauler Syndrome

SARS-CoV2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04903132
• Other study ID #: 20-011877
• Status: Enrolling by invitation
• Start date: March 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2 Infection

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials