Long-term Impact in Intensive Care Survivors of Coronavirus Disease (COVID-19)

Completed

• Conditions: COVID-19

• Registration Number: NCT05175339
• Lead Sponsor: Johns Hopkins University

Brief Summary

The Investigator seeks to evaluate the long term neurological and pulmonary sequelae of COVID-19.

Detailed Description

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.

Study Timeline

• Study Start: 2021-09-29
• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-03
• Status Verified: 2023-11
• Primary Completion: 2023-11-13
• Study Completion: 2023-11-13
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Clinically suspected or laboratory confirmed COVID-19 infection by real-time PCR
• Admission to an intensive care unit for COVID-19 and discharge

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Exclusion Criteria

• Pregnancy
• Participants unable to complete long-term follow-up due to logistical problems
• Participant paralyzed before being admitted to hospital for COVID-19
• History of pulmonary resection
• Previous pulmonary transplant
• Documented advanced neurologic order for which the patient is unable to carry out 6 minute walk test
• Documented psychiatric disease for which the patient is unable to carry out interview

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pulmonary capacity as assessed with forced expiratory volume	3 months and 9 months post-discharge	Forced expiratory volume will be measured with pulmonary function testing.
Change in pulmonary quality of life as assessed by St. George's Respiratory Questionnaire	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.
Change in pulmonary capacity as assessed with forced expiratory ratio	3 months and 9 months post-discharge	Forced expiratory ratio will be measured with pulmonary function testing.
Change in cardiopulmonary and musculoskeletal strength as assessed by a six minute walk test	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.
Evaluation of residual pulmonary pathology as assessed by a chest x-ray	9 months post-discharge	Chest X-Ray will be used in the evaluation of residual pulmonary pathology.
Change in pulmonary capacity as assessed with forced vital capacity	3 months and 9 months post-discharge	Forced vital capacity will be measured with pulmonary function testing.

Secondary Outcome Measures

Name	Time	Method
Change in cognitive function as assessed by BrainCheck	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.
Change in quality of life as assessed by Pain, Enjoyment of life, and General activity (PEG) screening tool	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.
Change in cognitive function as assessed by the Montreal Cognitive Assessment (MoCA)	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.
Change in prevalence of anxiety symptoms as determined by GAD7	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.
Change in quality of life as assessed by Fatigue Severity Scale	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.
Change in health-related Quality of Life as assessed by the short form (SF)-36 survey	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.
Change in post-traumatic stress disorder (PTSD) symptoms with PTSD-5	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.
Change in depressive symptoms as determined by PHQ-9	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.
Neurological assessment with brain MRI	3 months post-discharge	Brain MRI to assess clinical and/or subclinical brain injury such as infarcts, hemorrhages, and microhemorrhages.

Trial Locations

Locations (2)

University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States