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

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

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

• Study Contact: Name: Sung-Min Cho, DO, MHS; Phone Number: 410-955-2611; Email: csungmi1@jhmi.edu
• Study Contact Backup: Name: Glenn Whitman, MD; Phone Number: 410-955-2800; Email: gwhitman@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study population includes polymerase chain reaction (PCR) confirmed COVID-19 patients at Johns Hopkins Hospital and UT Houston Health Science Center who required intensive care unit admission for COVID-19 management.

Description

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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pulmonary quality of life as assessed by St. George's Respiratory Questionnaire	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.	3 months and 9 months post-discharge
Change in pulmonary capacity as assessed with forced vital capacity	Forced vital capacity will be measured with pulmonary function testing.	3 months and 9 months post-discharge
Change in pulmonary capacity as assessed with forced expiratory volume	Forced expiratory volume will be measured with pulmonary function testing.	3 months and 9 months post-discharge
Change in pulmonary capacity as assessed with forced expiratory ratio	Forced expiratory ratio will be measured with pulmonary function testing.	3 months and 9 months post-discharge
Change in cardiopulmonary and musculoskeletal strength as assessed by a six minute walk test	Six Minute Walk Test provides an objective measure of cardiopulmonary and musculoskeletal function by recording distance (in meters) walked in six minutes.	3 months and 9 months post-discharge
Evaluation of residual pulmonary pathology as assessed by a chest x-ray	Chest X-Ray will be used in the evaluation of residual pulmonary pathology.	3 months post-discharge
Evaluation of residual pulmonary pathology as assessed by a chest x-ray	Chest X-Ray will be used in the evaluation of residual pulmonary pathology.	9 months post-discharge

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Gilead Sciences
• Investigators: Study Director: Jannelle Molina, Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Actual): November 13, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IRB00276578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared with other institutions. Deidentified information will be shared between the two site locations and with investigators involved in the AFTERCOR trial with Gilead sciences.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No