Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil
Study Details
Study Description
Brief Summary
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COVID-19 ARDS survivors Survivors of hospitalization due to ARDS caused by SAS-CoV-2. |
Other: COVID-19
SARS-CoV-2 infection
Other: ARDS
Acute respiratory distress syndrome
|
| Non-COVID-19 ARDS survivors Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2. |
Other: ARDS
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. |
Outcome Measures
Primary Outcome Measures
- Diffusion capacity for carbon monoxide [The outcome will be assessed 6 months after enrollment]
Proportion of participants with diffusion capacity for carbon monoxide < 80% of predicted
Secondary Outcome Measures
- Physical functional status [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)
- Instrumental Activities of Daily Living [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)
- Muscular function and strength [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)
- Score of dyspnea [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.
- Utility score of health related quality of life [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).
- Radiologic patterns of intersticial lung disease [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.
- Radiologic patterns of myocarditis sequalae [The outcome will be assessed at 6 months after enrollment]
Radiologic patterns of myocarditis sequalae as assessed by cardiac magnetic resonance imaging
- Radiologic patterns of sarcopenia [The outcome will be assessed at 6 months after enrollment]
Radiologic patterns of sarcopenia as assessed by high resolution computed tomography chest scan.
- Incidence of major cardiovascular events [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)
- Incidence of thromboembolic events [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)
- Incidence of all-cause mortality [The outcome will be assessed at 3 and 6 months after enrollment]
Incidence of all-cause mortality
- Percentage of predicted peak oxygen consumption [The outcome will be assessed at 6 months after enrollment]
Percentage of predicted peak oxygen consumption as assessed by treadmill cardiopulmonary exercise cardiopulmonary exercise
- Peak oxygen consumption [The outcome will be assessed at 6 months after enrollment]
Peak oxygen as assessed by treadmill cardiopulmonary exercise
- Peak oxygen pulse [The outcome will be assessed at 6 months after enrollment]
Peak oxygen pulse as assessed by treadmill cardiopulmonary exercise
- Oxygen uptake efficiency slope [The outcome will be assessed at 6 months after enrollment]
Oxygen uptake efficiency slope as assessed by treadmill cardiopulmonary exercise
- Minute ventilation/carbon dioxide production slope ratio [The outcome will be assessed at 6 months after enrollment]
Minute ventilation/carbon dioxide production slope as assessed by treadmill cardiopulmonary exercise
- Forced vital capacity [The outcome will be assessed at 6 months after enrollment]
Forced expiratory capacity as assessed by spirometry
- Forced expiratory volume in one second [The outcome will be assessed at 6 months after enrollment]
Forced expiratory volume in one second as assessed by spirometry
- Forced expiratory volume in one second/ Forced vital capacity ratio [The outcome will be assessed at 6 months after enrollment]
Forced expiratory volume in one second/ Forced vital capacity ratio as assessed by spirometry
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hospital Moinhos de Vento
Investigators
- Principal Investigator: Regis G Rosa, MD, PhD, Hospital Moinhos de Vento
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pos-COVID Brasil 3