Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination
NCT04794829
COVID-19, Coronaviridae Infections
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT05175339
The Investigator seeks to evaluate the long term neurological and pulmonary sequelae of COVID-19.
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Notify Me18 year and older
All sexes
Observational
Johns Hopkins Hospital, Baltimore, Maryland, United States
Recent data suggests that survivors of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or (COVID-19) report adverse health status, including neurological and cognitive deficits and impaired pulmonary function, even months after discharge. Adult COVID-19 survivors after ICU stay, who are noted to have increased mortality and organ failure, are at higher risk of long-term disabilities and impaired quality of life. This study is one branch of a multi-site study coordinated by Gilead Sciences, in which participants who were critically ill with COVID-19 will be followed at three and nine months after discharge to test pulmonary function, cognitive function, and quality of life.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 months and 9 months post-discharge
St. George's Respiratory Questionnaire measures quality of life associated with chronic respiratory diseases. It has been used in various reports of long-term impact of acute respiratory distress syndrome. Scores for each domain range from 0 to 100, with a lower score indicating better pulmonary-specific quality of life.
Time frame: 3 months and 9 months post-discharge
Forced vital capacity will be measured with pulmonary function testing.
Time frame: 3 months and 9 months post-discharge
Forced expiratory volume will be measured with pulmonary function testing.
Time frame: 3 months and 9 months post-discharge
Forced expiratory ratio will be measured with pulmonary function testing.
Time frame: 3 months and 9 months post-discharge
Six Minute Walk Test provides an objective measure of cardiopulmonary and musculoskeletal function by recording distance (in meters) walked in six minutes.
Time frame: 3 months post-discharge
Chest X-Ray will be used in the evaluation of residual pulmonary pathology.
Time frame: 9 months post-discharge
Chest X-Ray will be used in the evaluation of residual pulmonary pathology.
Time frame: 3 months and 9 months post-discharge
Montreal Cognitive Assessment assesses cognitive impairment and recovery by evaluating attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.
Time frame: 3 months and 9 months post-discharge
BrainCheck is a computer-based test that assesses a variety of cognitive domains. For each individual test, the BrainCheck platform provides standard scores and percentile ranks. Additionally, the platform provides a composite score for an overall assessment of cognitive function. These scores are adjusted for age, derived from a normative database ranging from ages 10 to 99. Patient scores that fall within a range of one standard deviation above and below the mean indicate "normal" cognitive function. Low scores outside of this range suggest cognitive impairment.
Time frame: 3 months and 9 months post-discharge
PHQ-9 is a nine question screening tool that aids in the diagnosis and symptom tracking of depression. The possible range of scores is 0-27. Scores from 0-4 represent minimal depression, 5-9 represents mild depression, 10-14 represents moderate depression, 15-19 represents moderately severe depression, and 20-27 represents severe depression.
Time frame: 3 months and 9 months post-discharge
GAD7 is a seven question tool used to measure severity of generalized anxiety disorder. Responses are measured on a scale from 0-21, with higher scores representing more severe anxiety.
Time frame: 3 months and 9 months post-discharge
Fatigue severity scale measures the severity of fatigue and its impact on a person's lifestyle using a 9-item scale. Each item is scored on a 7 point scale. Total scores range from 9-63 with higher scores representing greater fatigue severity.
Time frame: 3 months and 9 months post-discharge
PEG tracks severity of pain and impact on quality of life using three questions. The mean response is calculated from the three items. Total score ranges from 0-10 with lower scores representing less pain and more favorable quality of life.
Time frame: 3 months and 9 months post-discharge
PTSD-5 is a five-question screening tool for identification of post-traumatic stress disorder. Total score ranges from 0-5, with scores of 3 or greater representing probable PTSD.
Time frame: 3 months post-discharge
Brain MRI to assess clinical and/or subclinical brain injury such as infarcts, hemorrhages, and microhemorrhages.
Time frame: 3 months and 9 months post-discharge
The SF-36 survey is a questionnaire that assesses the eight domains of physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, physical energy, and general health perceptions. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Johns Hopkins University
Other
Long-term Impact in Intensive Care Survivors of Coronavirus Disease-19
Acronym: AFTERCOR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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