Post Acute Sequelae of COVID-19

NCT04964115 | Active Not Recruiting

• 1 other identifier: 210436
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Natural history of recovery from COVID-19

  Incidence, 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.

  up to 5 years

Secondary Outcomes (1)

• Natural history of patients who do not recover from COVID-19

  up to 5 years

Interventions

Cohort study OTHER

This cohort study does not involve an intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with history of COVID-19 seen at Vanderbilt or an affiliated health facility.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt_University MC

Nashville, Tennessee, 37208, United States

Location

MeSH Terms

Conditions

COVID-19; Pulmonary Fibrosis

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Carla M Sevin, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: July 15, 2021
• Study Start: August 10, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)