Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Study for the Assessment of Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil

Conditions
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COVID-19, ARDS

Intervention / Treatment
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* Other: COVID-19
* Other: ARDS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 ARDS survivors<br>Survivors of hospitalization due to ARDS caused by SAS-CoV-2. | Other: COVID-19<br>* SARS-CoV-2 infection<br>Other: ARDS<br>* Acute respiratory distress syndrome<br>|
| Non-COVID-19 ARDS survivors<br>Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2. | Other: ARDS<br>* Acute respiratory distress syndrome<br>|
| Family controls<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |