Long-Term Study of COVID-19 Infection and Long COVID
ConditionSARS CoV-2 Post-Acute Sequelae
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 75 years.
Previous laboratory-confirmed SARS-CoV-2 infection.
Willing and able to provide informed consent.
Able to complete study questionnaires and study procedures.
Disqualifiers
Current severe periodontal disease with bleeding gums.
Current oral herpes flare, aphthous ulcer, or oral candidiasis (thrush).
Oral viral or bacterial infection within the previous 30 days.
Dry mouth that would prevent adequate saliva collection.
Trial population
Adults aged 18 to 75 years with a history of SARS-CoV-2 infection will be enrolled. The study will include individuals with and without persistent symptoms following infection to characterize the prevalence, severity, and persistence of PASC and identify demographic, clinical, and biological factors associated with Long COVID. Approximately 500 participants will be enrolled at the University of North Carolina at Chapel Hill.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
This study is observational. Only patients who have previously tested positive for SARS-CoV-2 infection or are experiencing ongoing symptoms.
Other interventionOther:
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: COVID-19+1 intervention
Trial outcomes
Primary outcomes
1
Salivary Proteomic Profile
Unbiased and untargeted mass spectrometric analysis of saliva proteins to obtain a specific proteomic profile
Time frame
During active infection through three months post infection2
Salivary Metabolomic Profile
Unbiased and untargeted mass spectrometric analysis of saliva metabolites to obtain a specific metabolomic profile
Time frame
During active infection through three months post infection3
Validated Health Questionnaires: SBQ-LC (Symptom Burden Questionnaire - Long COVID)
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 infection4
Validated Health Questionnaire: C19-YRS (COVID-19 Yorkshire Rehabilitation Scale)
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 infectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
Source ClinicalTrials.gov