Post Acute Sequelae of COVID-19 (PASC)

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Vanderbilt University Medical Center

Status

Enrolling

Conditions

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

Treatments

Other: Cohort study

Study type

Observational

Funder types

Other

Identifiers

NCT04964115
210436

Details and patient eligibility

About

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.

Full 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).

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

none

Trial contacts and locations

0

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Central trial contact

Peter J Edmonds, MD; Carla M Sevin, MD

Data sourced from clinicaltrials.gov

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