Status:
COMPLETED
Endocrine, Metabolic and Microbiome Influence on the Post-acute Sequelae SARS-CoV-2 (PASC)
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Covid19
Eligibility:
All Genders
18-80 years
Brief Summary
The aim of this study is characterize the endocrine, metabolic and microbiomes of patients with post-acute sequelae SARS-CoV-2 infection (PASC) and patients that have recovered from COVID without ling...
Detailed Description
The onset of the COVID-19 pandemic has led to a subset of patients that, once recovered from the acute infection, also experience an intractable and debilitating set of lingering symptoms termed post-...
Eligibility Criteria
Inclusion
- COVID Non-Symptomatic controls (nPASC)
- Inclusion criteria
- Male or female with a history of COVID with diagnosis confirmed by PCR test.
- Minimum of 6 months since diagnosis of COVID by PCR test.
- Ages 18 to 80 years.
- Participant is willing and able to give informed consent for participation in the study.
- Exclusion criteria
- Current COVID infection.
- Unable to walk unassisted.
- Significant heart, liver, kidney, blood or respiratory disease as determined by Principal Investigator.
- Uncontrolled diabetes mellitus.
- Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma).
- Current alcohol or drug abuse.
- History of psychosis.
- Pregnancy or become pregnant during the trial.
- Subjects who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
- Other medical condition or medication administration deemed exclusionary by the study investigators.
- COVID Symptomatic Subjects (PASC)
- Male or female with a history of COVID with diagnosis confirmed by PCR test.
- Has been seen at UTMB Post COVID clinic.
- Minimum of 6 months since diagnosis of COVID by PCR test.
- Ages 18 to 80 years.
- Score of 3 or higher on any question 1-3 of the Brief Fatigue Inventory (BFI) questionnaire.
- Participant is willing and able to give informed consent for participation in the study.
Exclusion
- Current COVID infection.
- Unable to walk unassisted.
- Significant heart, liver, kidney, blood or respiratory disease.
- Uncontrolled diabetes mellitus.
- Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma).
- Current alcohol or drug abuse.
- History of psychosis.
- Pregnancy or become pregnant during the trial.
- Subjects who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
- Other medical condition or medication administration deemed exclusionary by the study investigators.
Key Trial Info
Start Date :
May 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04860869
Start Date
May 12 2021
End Date
May 31 2022
Last Update
October 28 2024
Active Locations (1)
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1
The University of Texas Medical Branch
Galveston, Texas, United States, 77555