Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil
2022년 2월 2일 업데이트: Hospital Moinhos de Vento
Prospective Study for the Assessment of Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil
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.
연구 개요
연구 유형
관찰
등록 (예상)
318
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Geraldine Trott, PhD
- 전화번호: +5551994407117
- 이메일: geraldine.trott@hmv.org.br
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
해당 없음
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
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
설명
COHORT OF SURVIVORS OF ARDS CAUSED BY COVID-19
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by SAS-CoV-2.
|
SARS-CoV-2 infection
Acute respiratory distress syndrome
|
|
Non-COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2.
|
Acute respiratory distress syndrome
|
|
Family controls
Family controls of participants with ARDS (either due to COVID-19 or other etiologies) without history of COVID-19 or hospitalization in the last 12 months.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diffusion capacity for carbon monoxide
기간: The outcome will be assessed 6 months after enrollment
|
Proportion of participants with diffusion capacity for carbon monoxide < 80% of predicted
|
The outcome will be assessed 6 months after enrollment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Physical functional status
기간: The outcome will be assessed at 3 and 6 months after enrollment
|
Physical functional status as assessed by the modified Barthel index (score ranges from 0 to 100; higher scores indicate less functional dependence)
|
The outcome will be assessed at 3 and 6 months after enrollment
|
|
Instrumental Activities of Daily Living
기간: The outcome will be assessed at 3 and 6 months after enrollment
|
The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale (the score ranges from 0 to 8, with higher scores indicating less dependence)
|
The outcome will be assessed at 3 and 6 months after enrollment
|
|
Muscular function and strength
기간: The outcome will be assessed at 3 and 6 months after enrollment
|
Muscular function and strength as assessed by Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire.
Scale scores range from 0 (best) to 10 (worst)
|
The outcome will be assessed at 3 and 6 months after enrollment
|
|
Score of dyspnea
기간: The outcome will be assessed at 3 and 6 months after enrollment
|
The outcome will be assessed using the modified medical research council dyspnea scale.
Scores ranges from 0 to 4, with higher scores indicating worse symptoms.
|
The outcome will be assessed at 3 and 6 months after enrollment
|
|
Utility score of health related quality of life
기간: The outcome will be assessed at 3 and 6 months after enrollment
|
The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire.
The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
|
The outcome will be assessed at 3 and 6 months after enrollment
|
|
Radiologic patterns of intersticial lung disease
기간: The outcome will be assessed at 6 months after enrollment
|
Radiologic patterns of intersticial lung disease as assessed by high resolution computed tomography chest scan.
|
The outcome will be assessed at 6 months after enrollment
|
|
Radiologic patterns of myocarditis sequalae
기간: The outcome will be assessed at 6 months after enrollment
|
Radiologic patterns of myocarditis sequalae as assessed by cardiac magnetic resonance imaging
|
The outcome will be assessed at 6 months after enrollment
|
|
Radiologic patterns of sarcopenia
기간: The outcome will be assessed at 6 months after enrollment
|
Radiologic patterns of sarcopenia as assessed by high resolution computed tomography chest scan.
|
The outcome will be assessed at 6 months after enrollment
|
|
Incidence of major cardiovascular events
기간: The outcome will be assessed at 3 and 6 months after enrollment
|
Incidence of major cardiovascular events (composite endpoint of non-fatal stroke, non-fatal acute myocardial infarction, or cardiovascular death)
|
The outcome will be assessed at 3 and 6 months after enrollment
|
|
Incidence of thromboembolic events
기간: The outcome will be assessed at 3 and 6 months after enrollment
|
Incidence of thromboembolic events (composite endpoint of pulmonary embolism and deep venous thrombosis)
|
The outcome will be assessed at 3 and 6 months after enrollment
|
|
Incidence of all-cause mortality
기간: The outcome will be assessed at 3 and 6 months after enrollment
|
Incidence of all-cause mortality
|
The outcome will be assessed at 3 and 6 months after enrollment
|
|
Percentage of predicted peak oxygen consumption
기간: The outcome will be assessed at 6 months after enrollment
|
Percentage of predicted peak oxygen consumption as assessed by treadmill cardiopulmonary exercise cardiopulmonary exercise
|
The outcome will be assessed at 6 months after enrollment
|
|
Peak oxygen consumption
기간: The outcome will be assessed at 6 months after enrollment
|
Peak oxygen as assessed by treadmill cardiopulmonary exercise
|
The outcome will be assessed at 6 months after enrollment
|
|
Peak oxygen pulse
기간: The outcome will be assessed at 6 months after enrollment
|
Peak oxygen pulse as assessed by treadmill cardiopulmonary exercise
|
The outcome will be assessed at 6 months after enrollment
|
|
Oxygen uptake efficiency slope
기간: The outcome will be assessed at 6 months after enrollment
|
Oxygen uptake efficiency slope as assessed by treadmill cardiopulmonary exercise
|
The outcome will be assessed at 6 months after enrollment
|
|
Minute ventilation/carbon dioxide production slope ratio
기간: The outcome will be assessed at 6 months after enrollment
|
Minute ventilation/carbon dioxide production slope as assessed by treadmill cardiopulmonary exercise
|
The outcome will be assessed at 6 months after enrollment
|
|
Forced vital capacity
기간: The outcome will be assessed at 6 months after enrollment
|
Forced expiratory capacity as assessed by spirometry
|
The outcome will be assessed at 6 months after enrollment
|
|
Forced expiratory volume in one second
기간: The outcome will be assessed at 6 months after enrollment
|
Forced expiratory volume in one second as assessed by spirometry
|
The outcome will be assessed at 6 months after enrollment
|
|
Forced expiratory volume in one second/ Forced vital capacity ratio
기간: The outcome will be assessed at 6 months after enrollment
|
Forced expiratory volume in one second/ Forced vital capacity ratio as assessed by spirometry
|
The outcome will be assessed at 6 months after enrollment
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Regis G Rosa, MD, PhD, Hospital Moinhos de Vento
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2022년 2월 15일
기본 완료 (예상)
2023년 11월 15일
연구 완료 (예상)
2023년 11월 15일
연구 등록 날짜
최초 제출
2022년 2월 1일
QC 기준을 충족하는 최초 제출
2022년 2월 2일
처음 게시됨 (실제)
2022년 2월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 2월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 2월 2일
마지막으로 확인됨
2022년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pos-COVID Brasil 3
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .