Long-term Impact in Intensive Care Survivors of Coronavirus Disease-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in pulmonary capacity as assessed with forced expiratory volume
研究概览
简要总结
The Investigator seeks to evaluate the long term neurological and pulmonary sequelae of COVID-19.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically suspected or laboratory confirmed COVID-19 infection by real-time PCR
- •Admission to an intensive care unit for COVID-19 and discharge
排除标准
- •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
结局指标
主要结局
Change in pulmonary capacity as assessed with forced expiratory volume
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 3 months and 9 months post-discharge
Forced vital capacity will be measured with pulmonary function testing.
次要结局
- Change in cognitive function as assessed by BrainCheck(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(3 months and 9 months post-discharge)
- Change in cognitive function as assessed by the Montreal Cognitive Assessment (MoCA)(3 months and 9 months post-discharge)
- Change in prevalence of anxiety symptoms as determined by GAD7(3 months and 9 months post-discharge)
- Change in quality of life as assessed by Fatigue Severity Scale(3 months and 9 months post-discharge)
- Change in health-related Quality of Life as assessed by the short form (SF)-36 survey(3 months and 9 months post-discharge)
- Change in post-traumatic stress disorder (PTSD) symptoms with PTSD-5(3 months and 9 months post-discharge)
- Change in depressive symptoms as determined by PHQ-9(3 months and 9 months post-discharge)
- Neurological assessment with brain MRI(3 months post-discharge)