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

• Conditions: COVID-19; ARDS
• Interventions: Other: COVID-19; Other: ARDS

• Registration Number: NCT05225194
• Lead Sponsor: Hospital Moinhos de Vento

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-02
• Last Update Submitted: 2022-02-02
• Study First Posted: 2022-02-04
• Last Update Posted: 2022-02-04
• Study Start: 2022-02-15
• Primary Completion: 2023-11-15
• Study Completion: 2023-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 318

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 ARDS survivors	COVID-19	Survivors of hospitalization due to ARDS caused by SAS-CoV-2.
Non-COVID-19 ARDS survivors	ARDS	Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2.
COVID-19 ARDS survivors	ARDS	Survivors of hospitalization due to ARDS caused by SAS-CoV-2.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
Incidence of all-cause mortality	The outcome will be assessed at 3 and 6 months after enrollment	Incidence of all-cause mortality
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)
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 sarcopenia	The outcome will be assessed at 6 months after enrollment	Radiologic patterns of sarcopenia as assessed by high resolution computed tomography chest scan.
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
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
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
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)
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
Oxygen uptake efficiency slope	The outcome will be assessed at 6 months after enrollment	Oxygen uptake efficiency 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/ 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