Post-Acute COVID-19PASC VQNCT05866952
Ventilatory and Perfusion Abnormalities in Individuals With Post-Acute Sequelae of SARS-CoV-2 Infection
An observational study of Post-Acute COVID-19 and Post COVID-19 Condition, run by Tufts Medical Center at 1 site in United States.
Trial summary
Prospective cohort study to evaluate the utility of quantitative CT analysis to assess ventilation and perfusion defects in patients with Post-acute Sequelae of SARS-CoV-2 (PASC) and functional limitations Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Acute COVID-19, Post COVID-19 Condition, Post Viral Fatigue
- What is being tested?
- Computed Tomography of the Chest
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2023to 31 Dec 2026
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The primary population of interest includes participants with a history of COVID-19 who continue to have symptoms of dyspnea, fatigue, or exercise intolerance 3 months beyond their initial infection. The comparison cohorts will include 2 controls: individuals fully recovered from prior COVID-19 and healthy controls without a history of COVID-19.
Who may be able to join
- Age ≥ 18
- Self-reported or documented SARS-CoV-2 infection by RT-PCR or Antigen testing > 3 months ago or no previous history of SARS-CoV-2 infection (control group only)
- Normal or mild abnormalities on baseline Pulmonary Function Tests (PFTs)
- New or worsening symptoms of chronic fatigue, dyspnea or exercise intolerance after COVID-19 with otherwise unclear etiology (PASC group only)
Who cannot join
- SARS-CoV-2 infection by RT-PCR or Antigen testing within the last 3 months
- Inability to provide consent or non-English speaking
- Pregnancy
- Any respiratory infection in last 4 weeks
- PFT relative contraindications
- History of major cardiovascular, pulmonary, renal, hepatic, autoimmune or neuromuscular disease including asthma, COPD, interstitial lung disease, heart failure, pulmonary arterial hypertension, or prior pulmonary embolism
- Active malignancy undergoing treatment or history of malignancy involving the lung
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
Tufts Medical Center
Boston, Massachusetts, 02111
Bipin Malla
Maher Ghamloush, MD
About this study
Official title: Quantitative Computed Tomography to Assess Ventilatory and Perfusion Abnormalities in Individuals With Post-Acute Sequelae of SARS-CoV-2 Infection
Prospective cohort study to evaluate the utility of quantitative CT analysis to assess ventilation and perfusion defects in patients with Post-acute Sequelae of SARS-CoV-2 (PASC) and functional limitations
Read the detailed description
This is a study to describe the overall pattern of lung ventilation and perfusion defects in individuals with PASC. Subjects with PASC with a documented history of COVID-19 and persistent symptoms of fatigue, dyspnea, and/or exercise intolerance will complete questionnaires, and undergo pulmonary function tests, 6-minute walk tests, and a low dose CT chest to describe the overall pattern of lung regional ventilation and blood distribution and to compare this pattern to asymptomatic controls with and without prior COVID-19.
- Being tested
- Computed Tomography of the Chest
- Keywords
- Ventilation Perfusion Mismatch
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography of the ChestDiagnostic test
Quantitative Computed Tomography of the chest in the inspiratory and expiratory phases will be performed to assess regional lung ventilation as well as pulmonary vascular volume and distribution
| Study group | Role | What they receive |
|---|---|---|
| Post-Acute Sequelae of SARS-CoV-2 (PASC) Group | Subjects with PASC with a documented history of COVID-19 and persistent symptoms of fatigue, dyspnea, and/or exercise intolerance Receives: Diagnostic Test: Computed Tomography of the Chest | |
| Control: Fully recovered COVID-19 | Subjects with a history of COVID-19 who have fully recovered from COVID-19 with no post-acute sequelae of SARS-Cov-2 Receives: Diagnostic Test: Computed Tomography of the Chest | |
| Control: No history of COVID-19 | Healthy subjects without a documented history of COVID-19, no current symptoms, and a normal baseline High resolution CT of the chest Receives: Diagnostic Test: Computed Tomography of the Chest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of regional lung ventilation
Measured: 1 day
Measures of blood volume distribution
Measured: 1 day
Secondary outcomes (4)
Dyspnea severity scores
Measured: 1 day
Fatigue severity scores
Measured: 1 day
Quality of life scores
Measured: 1 day
Six-minute walk distance
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start5 Jun 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute COVID-19Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- 4DMedical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866952
- Sponsor's protocol ID
- 2337
- Acronym
- PASC VQ
- Status last verified
- Jul 2025
- First submitted
- 16 May 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Computed Tomography to Assess Ventilatory and Perfusion Abnormalities in Individuals With Post-Acute Sequelae of SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT05866952
- Acronym / sponsor ID
- PASC VQ / 2337
- Keywords
- Ventilation Perfusion Mismatch
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- 4DMedical
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 May 2023 (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.
Prospective cohort study to evaluate the utility of quantitative CT analysis to assess ventilation and perfusion defects in patients with Post-acute Sequelae of SARS-CoV-2 (PASC) and functional limitations
Detailed description
This is a study to describe the overall pattern of lung ventilation and perfusion defects in individuals with PASC. Subjects with PASC with a documented history of COVID-19 and persistent symptoms of fatigue, dyspnea, and/or exercise intolerance will complete questionnaires, and undergo pulmonary function tests, 6-minute walk tests, and a low dose CT chest to describe the overall pattern of lung regional ventilation and blood distribution and to compare this pattern to asymptomatic controls with and without prior COVID-19.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post-Acute Sequelae of SARS-CoV-2 (PASC) Group | – | Diagnostic Test: Computed Tomography of the ChestSubjects with PASC with a documented history of COVID-19 and persistent symptoms of fatigue, dyspnea, and/or exercise intolerance |
| Control: Fully recovered COVID-19 | – | Diagnostic Test: Computed Tomography of the ChestSubjects with a history of COVID-19 who have fully recovered from COVID-19 with no post-acute sequelae of SARS-Cov-2 |
| Control: No history of COVID-19 | – | Diagnostic Test: Computed Tomography of the ChestHealthy subjects without a documented history of COVID-19, no current symptoms, and a normal baseline High resolution CT of the chest |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The primary population of interest includes participants with a history of COVID-19 who continue to have symptoms of dyspnea, fatigue, or exercise intolerance 3 months beyond their initial infection. The comparison cohorts will include 2 controls: individuals fully recovered from prior COVID-19 and healthy controls without a history of COVID-19.
Key inclusion criteria (4 listed)
- Age ≥ 18
- Self-reported or documented SARS-CoV-2 infection by RT-PCR or Antigen testing > 3 months ago or no previous history of SARS-CoV-2 infection (control group only)
- Normal or mild abnormalities on baseline Pulmonary Function Tests (PFTs)
- New or worsening symptoms of chronic fatigue, dyspnea or exercise intolerance after COVID-19 with otherwise unclear etiology (PASC group only)
Key exclusion criteria (7 listed)
- SARS-CoV-2 infection by RT-PCR or Antigen testing within the last 3 months
- Inability to provide consent or non-English speaking
- Pregnancy
- Any respiratory infection in last 4 weeks
- PFT relative contraindications
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 |
|---|---|---|
| Computed Tomography of the ChestQuantitative Computed Tomography of the chest in the inspiratory and expiratory phases will be performed to assess regional lung ventilation as well as pulmonary vascular volume and distribution | Diagnostic test | Control: Fully recovered COVID-19, Control: No history of COVID-19, Post-Acute Sequelae of SARS-CoV-2 (PASC) Group |
Primary outcome
Measures of regional lung ventilation
Time frame: 1 day
Measures of blood volume distribution
Time frame: 1 day
4 secondary outcomes
Dyspnea severity scores
Time frame: 1 day
Fatigue severity scores
Time frame: 1 day
Quality of life scores
Time frame: 1 day
Six-minute walk distance
Time frame: 1 day
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 20 Jul 2025.
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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.
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 Post-Acute COVID-19 and Post COVID-19 Condition, run by Tufts Medical Center 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 7 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 20 Jul 2025. 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 Bipin Malla (617-636-6304, tuftsmccorstudy@tuftsmedicalcenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of regional lung ventilation (time frame: 1 day). The study lists 2 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 20 Jul 2025.