Clinical trial NCT05175339: Long-term Impact in Intensive Care Survivors of Coronavirus Disease (COVID-19)
Official title: Long-term Impact in Intensive Care Survivors of Coronavirus Disease-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2022-01-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pulmonary quality of life as assessed by St. George's Respiratory Questionnaire
timeFrame: 3 months and 9 months post-discharge
measure: Change in pulmonary capacity as assessed with forced vital capacity
timeFrame: 3 months and 9 months post-discharge
measure: Change in pulmonary capacity as assessed with forced expiratory volume
timeFrame: 3 months and 9 months post-discharge
measure: Change in pulmonary capacity as assessed with forced expiratory ratio
timeFrame: 3 months and 9 months post-discharge
measure: Change in cardiopulmonary and musculoskeletal strength as assessed by a six minute walk test
timeFrame: 3 months and 9 months post-discharge
measure: Evaluation of residual pulmonary pathology as assessed by a chest x-ray
timeFrame: 3 months post-discharge
measure: Evaluation of residual pulmonary pathology as assessed by a chest x-ray
timeFrame: 9 months post-discharge
Secondary outcomes:
measure: Change in cognitive function as assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: 3 months and 9 months post-discharge
measure: Change in cognitive function as assessed by BrainCheck
timeFrame: 3 months and 9 months post-discharge
measure: Change in depressive symptoms as determined by PHQ-9
timeFrame: 3 months and 9 months post-discharge
measure: Change in prevalence of anxiety symptoms as determined by GAD7
timeFrame: 3 months and 9 months post-discharge
measure: Change in quality of life as assessed by Fatigue Severity Scale
timeFrame: 3 months and 9 months post-discharge
measure: Change in quality of life as assessed by Pain, Enjoyment of life, and General activity (PEG) screening tool
timeFrame: 3 months and 9 months post-discharge
measure: Change in post-traumatic stress disorder (PTSD) symptoms with PTSD-5
timeFrame: 3 months and 9 months post-discharge
measure: Neurological assessment with brain MRI
timeFrame: 3 months post-discharge
measure: Change in health-related Quality of Life as assessed by the short form (SF)-36 survey
timeFrame: 3 months and 9 months post-discharge
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: Gilead Sciences
name: Jannelle Molina
role: STUDY_DIRECTOR
References: