Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04964115 |
| Other study ID # |
210436 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 10, 2021 |
| Est. completion date |
May 2027 |
Study information
| Verified date |
June 2024 |
| Source |
Vanderbilt University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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).
