NCT05225194Unknown不适用
Prospective Study for the Assessment of Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 318
- 主要终点
- Diffusion capacity for carbon monoxide
研究概览
简要总结
The present multicenter prospective observational study aims to assess the long-term effects of COVID-19 on patients with Acute Respiratory Distress Syndrome (ARDS).
This is a hybrid design study with components of cohort and case-control designs. Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization will be followed up for a period of 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Age ≥18 years;
- •Hospitalization due to COVID-19;
- •Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
- •Diagnosis of ARDS during hospitalization according to the Berlin definition;
- •Expected to survive and be discharged directly home from the hospital.
排除标准
- •Severe comorbidity with life expectancy less than 3 months;
- •Unavailability to attend the study follow-up appointment;
- •Death during hospitalization;
- •Absence of proxy for patients with communication difficulties;
- •Refusal or withdrawal of agreement to participate.
- •COHORT OF SURVIVORS OF ARDS CAUSED BY OTHER ETIOLOGIES NOT ASSOCIATED WITH COVID-19
- •Inclusion Criteria:
- •Age ≥18 years;
- •Hospitalization;
- •Diagnosis of ARDS during hospitalization according to the Berlin definition;
- •Expected to survive and be discharged directly home from the hospital.
- •Exclusion Criteria:
- •Severe comorbidity with life expectancy less than 3 months;
- •Unavailability to attend the study follow-up appointment;
- •Death during hospitalization;
- •History of SARS-CoV-2 infection within the last 12 months;
- •Absence of proxy for patients with communication difficulties;
- •Refusal or withdrawal of agreement to participate.
- •FAMILY CONTROLS
- •Inclusion Criteria:
- •Age ≥18 years;
- •Family member of a enrolled participant (either from the COVID-19 ARDS cohort or from the non-COVID-19 ARDS cohort)
- •Exclusion Criteria:
- •Severe comorbidity with life expectancy less than 3 months;
- •Unavailability to attend the study follow-up appointment;
- •History of SARS-CoV-2 infection within the last 12 months;
- •History of non-elective hospitalization due to medical condition within the last 12 months;
- •Refusal or withdrawal of agreement to participate.
结局指标
主要结局
Diffusion capacity for carbon monoxide
时间窗: The outcome will be assessed 6 months after enrollment
Proportion of participants with diffusion capacity for carbon monoxide \< 80% of predicted
次要结局
- Score of dyspnea(The outcome will be assessed at 3 and 6 months after enrollment)
- Radiologic patterns of intersticial lung disease(The outcome will be assessed at 6 months after enrollment)
- Incidence of all-cause mortality(The outcome will be assessed at 3 and 6 months after enrollment)
- Physical functional status(The outcome will be assessed at 3 and 6 months after enrollment)
- Instrumental Activities of Daily Living(The outcome will be assessed at 3 and 6 months after enrollment)
- Muscular function and strength(The outcome will be assessed at 3 and 6 months after enrollment)
- Utility score of health related quality of life(The outcome will be assessed at 3 and 6 months after enrollment)
- Radiologic patterns of sarcopenia(The outcome will be assessed at 6 months after enrollment)
- Percentage of predicted peak oxygen consumption(The outcome will be assessed at 6 months after enrollment)
- Peak oxygen consumption(The outcome will be assessed at 6 months after enrollment)
- Peak oxygen pulse(The outcome will be assessed at 6 months after enrollment)
- Minute ventilation/carbon dioxide production slope ratio(The outcome will be assessed at 6 months after enrollment)
- Radiologic patterns of myocarditis sequalae(The outcome will be assessed at 6 months after enrollment)
- Incidence of major cardiovascular events(The outcome will be assessed at 3 and 6 months after enrollment)
- Incidence of thromboembolic events(The outcome will be assessed at 3 and 6 months after enrollment)
- Forced expiratory volume in one second(The outcome will be assessed at 6 months after enrollment)
- Oxygen uptake efficiency slope(The outcome will be assessed at 6 months after enrollment)
- Forced vital capacity(The outcome will be assessed at 6 months after enrollment)
- Forced expiratory volume in one second/ Forced vital capacity ratio(The outcome will be assessed at 6 months after enrollment)
研究者
相似试验
进行中（未招募）
不适用
Long-term Effectiveness, Safety, and Performance of the Evoke Closed-Loop SCS System to Treat Patients With Chronic Pain of the Trunk and/or LimbsChronic PainNCT04627974Saluda Medical Pty Ltd70
已完成
不适用
A Study Examining Long Response in Lung Cancer Patients Treated With Tarceva (Erlotinib)Non-Small Cell Lung CancerNCT02133508Hoffmann-La Roche172
尚未招募
不适用
Long-Term Outcomes of Different Surgical Techniques for Sacral Tarlov Cysts: A Prospective Cohort StudyNCT06756984Beijing Jishuitan Hospital150
进行中（未招募）
不适用
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia AHemophilia ANCT05911763Sanofi200
Unknown
不适用
An Observational Study on Long-Term Effectiveness and Safety of RoActemra/Actemra (Tocilizumab) in Daily Practice in Patients With Rheumatoid Arthritis (ICHIBAN)Rheumatoid ArthritisNCT01194401Hoffmann-La Roche3,404