SARS CoV-2 Post-Acute SequelaePASCNCT07781501
Long-Term Study of COVID-19 Infection and Long COVID
An observational study of SARS CoV-2 Post-Acute Sequelae, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SARS CoV-2 Post-Acute Sequelae
- What is being tested?
- This study is observational. Only patients who have previously tested positive for SARS-CoV-2 infection or are experiencing ongoing symptoms.
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599-7555
Laura A Jacox, PhD, DMD, MS, +1 847-702-0988, ljacox@live.unc.edu
Jeannene L Matthews, MA, M.Ed., CCC-SLP, 919-907-9685, jeannene_matthews@med.unc.edu
About this study
Official title: Longitudinal Study of Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection and Post-Acute Sequelae of COVID-19 (PASC)
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.
Read the detailed description
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.
- Conditions
- SARS CoV-2 Post-Acute Sequelae
- Being tested
- This study is observational. Only patients who have previously tested positive for SARS-CoV-2 infection or are experiencing ongoing symptoms.
- Keywords
- COVID-19, SARS-CoV-2, Long COVID
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study is observational. Only patients who have previously tested positive for SARS-CoV-2 infection or are experiencing ongoing symptoms.Other
Other:
| Study group | Role | What they receive |
|---|---|---|
| COVID-19+ | Adults who have previously had COVID-19 and may be experiencing ongoing symptoms or changes in their health following infection. Receives: Other: This study is observational. Only patients who have previously tested positive for SARS-CoV-2 infection or are experiencing ongoing symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Proteomic Profile
Unbiased and untargeted mass spectrometric analysis of saliva proteins to obtain a specific proteomic profile
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During active infection through three months post infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start4 Sep 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV-2 Post-Acute SequelaeStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Laura Jacox, PhD, DMD, MS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781501
- Sponsor's protocol ID
- 24-1425
- Other IDs
- R01DE035709
- Acronym
- PASC
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers outside of the approved study team. De-identified data may be used for future research in accordance with the informed consent, applicable regulations, and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection and Post-Acute Sequelae of COVID-19 (PASC)
- ClinicalTrials.gov ID
- NCT07781501
- Acronym / sponsor ID
- PASC / 24-1425
- Conditions
- SARS CoV-2 Post-Acute Sequelae
- Keywords
- COVID-19, SARS-CoV-2, Long COVID
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19+ | – | Other: This study is observational. Only patients who have previously tested positive for SARS-CoV-2 infection or are experiencing ongoing symptoms.Adults who have previously had COVID-19 and may be experiencing ongoing symptoms or changes in their health following infection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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+ |
Primary outcome
Salivary Proteomic Profile
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
Salivary Metabolomic 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
Validated Health Questionnaires: SBQ-LC (Symptom Burden Questionnaire - Long COVID)
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.
Validated Health Questionnaire: C19-YRS (COVID-19 Yorkshire Rehabilitation Scale)
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.
Validated Health Questionnaire: EFTER-COVID survey
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers outside of the approved study team. De-identified data may be used for future research in accordance with the informed consent, applicable regulations, and institutional policies.
Related trials for SARS CoV-2 Post-Acute Sequelae
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Recruiting
Effect of Hi-OxSR for the Treatment of Post COVID Condition
Long COVID, Post COVID-19 Condition
Not yet recruitingPhase 1/2
Taurine Supplementation in Adolescents With Post-COVID Condition
Long COVID, Post COVID-19 Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Jacox, PhD, DMD, MS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS CoV-2 Post-Acute Sequelae, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura A Jacox, PhD, DMD, MS (+1 847-702-0988, ljacox@live.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Proteomic Profile (time frame: During active infection through three months post infection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.