Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil
2022年2月2日 更新者：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.
調査の概要
研究の種類
観察的
入学 (予想される)
318
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Geraldine Trott, PhD
- 電話番号：+5551994407117
- メール：geraldine.trott@hmv.org.br
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
なし
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diffusion capacity for carbon monoxide
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physical functional status
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Regis G Rosa, MD, PhD、Hospital Moinhos de Vento
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2022年2月15日
一次修了 (予想される)
2023年11月15日
研究の完了 (予想される)
2023年11月15日
試験登録日
最初に提出
2022年2月1日
QC基準を満たした最初の提出物
2022年2月2日
最初の投稿 (実際)
2022年2月4日
学習記録の更新
投稿された最後の更新 (実際)
2022年2月4日
QC基準を満たした最後の更新が送信されました
2022年2月2日
最終確認日
2022年1月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Pos-COVID Brasil 3
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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