An observational study in COVID-19 and ARDS, sponsored by Hospital Moinhos de Vento. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-04.
Sponsored by Hospital Moinhos de Vento · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 318 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Hospital Moinhos de Vento is the lead sponsor of 34 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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:
Survivors of hospitalization due to ARDS caused by SAS-CoV-2.
Other: COVID-19 · Other: ARDS
Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2.
Other: ARDS
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.
SARS-CoV-2 infection
Acute respiratory distress syndrome
Diffusion capacity for carbon monoxide
Proportion of participants with diffusion capacity for carbon monoxide \< 80% of predicted
Time frame: The outcome will be assessed 6 months after enrollment
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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: The outcome will be assessed at 3 and 6 months after enrollment
Incidence of all-cause mortality
Incidence of all-cause mortality
Time frame: 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
Time frame: The outcome will be assessed at 6 months after enrollment
Peak oxygen consumption
Peak oxygen as assessed by treadmill cardiopulmonary exercise
Time frame: The outcome will be assessed at 6 months after enrollment
Peak oxygen pulse
Peak oxygen pulse as assessed by treadmill cardiopulmonary exercise
Time frame: The outcome will be assessed at 6 months after enrollment
Oxygen uptake efficiency slope
Oxygen uptake efficiency slope as assessed by treadmill cardiopulmonary exercise
Time frame: 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
Time frame: The outcome will be assessed at 6 months after enrollment
Forced vital capacity
Forced expiratory capacity as assessed by spirometry
Time frame: 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
Time frame: 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
Time frame: The outcome will be assessed at 6 months after enrollment
No study locations are listed for this record.
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Hospital Moinhos de Vento