Clinical trial NCT04964115: Post Acute Sequelae of COVID-19
Official title: Post Acute Sequelae of SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
Sars-CoV-2 Infection
Dyspnea Caused by 2019-nCoV
COVID-19 Acute Respiratory Distress Syndrome
Pulmonary Fibrosis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with history of COVID-19 seen at Vanderbilt or an affiliated health facility.

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Natural history of recovery from COVID-19
timeFrame: up to 5 years
Secondary outcomes:
measure: Natural history of patients who do not recover from COVID-19
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt_University MC
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Carla M Sevin, MD
role: PRINCIPAL_INVESTIGATOR
References: