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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 ARDS survivors | Survivors of hospitalization due to ARDS caused by SAS-CoV-2. |
| |
| Non-COVID-19 ARDS survivors | Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 | Other | SARS-CoV-2 infection |
| |
| ARDS |
| Measure | Description | Time Frame |
|---|---|---|
| Diffusion capacity for carbon monoxide | Proportion of participants with diffusion capacity for carbon monoxide < 80% of predicted | The outcome will be assessed 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Physical functional status | 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 |
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COHORT OF SURVIVORS OF ARDS CAUSED BY COVID-19
Inclusion Criteria:
Exclusion Criteria:
COHORT OF SURVIVORS OF ARDS CAUSED BY OTHER ETIOLOGIES NOT ASSOCIATED WITH COVID-19
Inclusion Criteria:
Exclusion Criteria:
FAMILY CONTROLS
Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geraldine Trott, PhD | Contact | +5551994407117 | geraldine.trott@hmv.org.br |
| Name | Affiliation | Role |
|---|---|---|
| Regis G Rosa, MD, PhD | Hospital Moinhos de Vento | Principal Investigator |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Other |
Acute respiratory distress syndrome |
|
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Incidence of all-cause mortality | The outcome will be assessed at 3 and 6 months after enrollment |
| Percentage of predicted peak oxygen consumption | 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 | Peak oxygen as assessed by treadmill cardiopulmonary exercise | The outcome will be assessed at 6 months after enrollment |
| Peak oxygen pulse | Peak oxygen pulse as assessed by treadmill cardiopulmonary exercise | The outcome will be assessed at 6 months after enrollment |
| Oxygen uptake efficiency slope | 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 | 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 | Forced expiratory capacity as assessed by spirometry | The outcome will be assessed at 6 months after enrollment |
| Forced expiratory volume in one second | 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 | Forced expiratory volume in one second/ Forced vital capacity ratio as assessed by spirometry | The outcome will be assessed at 6 months after enrollment |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |