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Ventilatory and Perfusion Abnormalities in Individuals With Post-Acute Sequelae of SARS-CoV-2 Infection

ConditionsPost-Acute COVID-19Post COVID-19 ConditionPost Viral FatigueDyspnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorTufts Medical Center

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Computed Tomography of the Chest

    Diagnostic 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

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Post-Acute Sequelae of SARS-CoV-2 (PASC) Group1 intervention
Group B: Control: Fully recovered COVID-191 intervention
Group C: Control: No history of COVID-191 intervention

Trial outcomes

Primary outcomes

1

Measures of regional lung ventilation

Time frame
1 day
2

Measures of blood volume distribution

Time frame
1 day

Secondary outcomes

1

Dyspnea severity scores

Time frame
1 day
2

Fatigue severity scores

Time frame
1 day
3

Quality of life scores

Time frame
1 day
4

Six-minute walk distance

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts Medical Center

Lead sponsor

4DMedical

Collaborator

Source ClinicalTrials.gov
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