Long-Term Study of COVID-19 Infection and Long COVID

NCT07781501 | Recruiting

• 2 other identifiers: 24-1425R01DE035709
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS CoV-2 Post-Acute Sequelae

Keywords

COVID-19; SARS-CoV-2; Long COVID

Outcome Measures

Primary Outcomes (5)

• Salivary Proteomic Profile

  Unbiased and untargeted mass spectrometric analysis of saliva proteins to obtain a specific proteomic profile

  During active infection through three months post infection

• Salivary Metabolomic Profile

  Unbiased and untargeted mass spectrometric analysis of saliva metabolites to obtain a specific metabolomic profile

  During active infection through three months post infection

• 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.

  During active infection through three months post infection

• 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.

  During active infection through three months post infection

• Validated Health Questionnaire: EFTER-COVID survey

  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.

  During active infection through three months post infection

Study Arms (1)

COVID-19+

Adults who have previously had COVID-19 and may be experiencing ongoing symptoms or changes in their health following infection.

Other: This study is observational. Only patients who have previously tested positive for SARS-CoV-2 infection or are experiencing ongoing symptoms.

Interventions

This study is observational. Only patients who have previously tested positive for SARS-CoV-2 infection or are experiencing ongoing symptoms. OTHER

Other:

COVID-19+

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Active alcohol or drug abuse.
• Medical or genetic syndrome or developmental delay that would prevent completion of study procedures or questionnaires.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599-7555, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Salivary samples

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Laura A Jacox, PhD, DMD, MS

CONTACT

+1 847-702-0988; ljacox@live.unc.edu

Jeannene L Matthews, MA, M.Ed., CCC-SLP

CONTACT

+1 919-357-5999; jeannene_matthews@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: September 4, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)