NCT Number: NCT07781501
This study will examine how common Long COVID is and how symptoms may persist over time in people who have previously had COVID-19. Researchers will collect information about participants' health and symptoms through questionnaires and may collect saliva and other non-invasive oral samples. The study will also examine biological factors in these samples that may be associated with persistent symptoms. The goal is to better understand why some people develop Long COVID and identify factors that may help predict who is more likely to experience persistent symptoms.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Chapel Hill, North Carolina, 27599-7555, United States
Location status: Recruiting
Jeannene L Matthews, MA, M.Ed., CCC-SLP
CONTACT
Laura A Jacox, PhD, DMD, MS
CONTACT
Laura A Jacox, PhD, DMD, MS
PRINCIPAL_INVESTIGATOR
Post-Acute Sequelae of COVID-19 (PASC), also known as Long COVID, is characterized by persistent or newly developed symptoms following SARS-CoV-2 infection. The biological mechanisms underlying persistent symptoms remain incompletely understood, particularly among individuals experiencing symptoms more than two years after infection.
This observational study will evaluate individuals with a history of SARS-CoV-2 infection to characterize the prevalence, severity, and persistence of PASC symptoms and identify demographic, clinical, and biological factors associated with these outcomes. Participants will complete questionnaires about their health and symptoms and provide saliva specimens for biological analyses.
Saliva will be evaluated for biological factors that may be associated with persistent symptoms, including proteins, metabolites, microorganisms, and immune-related markers.
Machine learning approaches will be used to integrate demographic, clinical, symptom, and saliva-based biological data to identify patterns associated with PASC. The study will evaluate whether these combined characteristics can be used to identify individuals who are more likely to experience persistent or severe symptoms following SARS-CoV-2 infection. The resulting models may help identify factors that contribute to Long COVID risk and inform future approaches for predicting persistent symptoms.
The study will include both newly enrolled participants and participants who previously participated in related SARS-CoV-2 research. Findings from this study may improve understanding of Long COVID and the factors associated with persistent symptoms following SARS-CoV-2 infection.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other:
Time frame: During active infection through three months post infection
Unbiased and untargeted mass spectrometric analysis of saliva proteins to obtain a specific proteomic profile
Time frame: During active infection through three months post infection
Unbiased and untargeted mass spectrometric analysis of saliva metabolites to obtain a specific metabolomic profile
Time frame: During active infection through three months post infection
This instrument assesses PASC-related symptom burden following COVID-19 infection.
Scoring: 0- None, 1- Mild, 2- Moderate, 3-Severe - Higher score reflects greater severity.
Time frame: During active infection through three months post infection
This instrument assesses the long-term physical, cognitive, and psychological outcomes following COVID-19 infection.
Scoring: 0-10 numerical scale; a higher score reflects greater severity.
Time frame: During active infection through three months post infection
This instrument assesses the long-term physical, cognitive, and psychological outcomes following COVID-19 infection. EFTER is not an abbreviation; it is the name of the survey, and it is the Danish word for "After"
Scoring: Yes/No - Higher score reflects More affected.
Contact information is provided by the study sponsor or research team.
Jeannene L Matthews, MA, M.Ed., CCC-SLP
CONTACT
Laura A Jacox, PhD, DMD, MS
CONTACT
University of North Carolina, Chapel Hill
Other
Longitudinal Study of Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection and Post-Acute Sequelae of COVID-19 (PASC)
Acronym: PASC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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