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Post Acute Sequelae of COVID-19

Post Acute Sequelae of SARS-CoV-2

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04964115
Acronym
PASC
Enrollment
500
Registered
2021-07-15
Start date
2021-08-10
Completion date
2028-05-31
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, COVID-19 Acute Respiratory Distress Syndrome, Dyspnea Caused by 2019-nCoV, Pulmonary Fibrosis, Sars-CoV-2 Infection

Brief summary

COVID-19, a novel coronavirus, has caused widespread mortality and morbidity since it emerged in 2019. There is ongoing research and growing literature describing severe acute respiratory syndrome (SARS-COV-2). There is a growing population of individuals who have recovered from acute SARS-COV-2 infection. The long-term effects of COVID-19 are unknown. There are growing reports of sequelae after acute SARS-CoV-2 not limited to fatigue, dyspnea, reactive airway disease, organizing pneumonia, pulmonary fibrosis, pulmonary hypertension, pulmonary emboli, and tracheal disease. The incidence and natural history of these findings is unstudied.

Detailed description

COVID-19 is a leading cause of death worldwide. The long-term effects of the virus are unknown. There is lack of reliable information about the natural history of post acute sequelae. Although there are limited evidence-based treatment guidelines, many patients receive unproven therapies. Given the mortality and morbidity associated with the illness and the growing number of patients who have survived COVID-19 the long-term effects are a growing area of inquiry. This study is designed to better understand the effects of SARS-CoV-2 that develop over time. This study will characterize the recovery process, epidemiology, and natural history of post-acute sequelae. This includes the clinical spectrum of recover and subsets of patients who have symptoms outside the standard course. Factors studied will include the individual, clinical context, severity of disease, duration of symptoms and the impact of treatment for acute SARS-CoV-2. This study will include a breadth of severity from those treated as outpatients, those requiring hospitalization, and those requiring critical care. Key personnel will extract data recorded in the electronic health record (EHR) as part of routine clinical care in the evaluation in treatment of COVID-19 and its sequelae. Data such as incidence, prevalence, demographics, comorbidities, duration of illness, severity, level of medical care, measures of organ function, drug treatments, laboratory values, pulmonary function tests, computed tomography images, and other data from clinical care will be retrospectively entered into electronic data capture (REDCap).

Interventions

OTHERCohort study

This cohort study does not involve an intervention

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or older * COVID-19 diagnosis * Seen in a Vanderbilt clinic or affiliated health facility

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Natural history of recovery from COVID-19up to 5 yearsIncidence, prevalence, age, sex, BMI, presence of comorbid conditions (including diabetes, hypertension, immunosuppression, or chronic lung disease), duration of illness (in days), level of medical care (intensive care unit, inpatient or outpatient), drug therapies received, pulmonary function tests, and computed tomography images.

Secondary

MeasureTime frameDescription
Natural history of patients who do not recover from COVID-19up to 5 yearsPhenotypes of recovery (complete recovery, delayed recovery, no recovery)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCarla M Sevin, MD

Vanderbilt University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026