Clinical trial NCT04903132: Cellular Senescence and COVID-19 Long-Hauler Syndrome
Official title: Cellular Senescence and Its Contribution to COVID-19 Long-Hauler Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: SARS-CoV2 Infection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between features of Long-Hauler Syndrome with markers of cellular senescence and SASP factors
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ryan T. Hurt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: