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

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

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 Overview

• Status: Not yet recruiting
• Conditions: COVID-19; ARDS
• Intervention / Treatment: Other: COVID-19; Other: ARDS

• Study Type: Observational
• Enrollment (Anticipated): 318

Contacts and Locations

• Study Contact: Name: Geraldine Trott, PhD; Phone Number: +5551994407117; Email: geraldine.trott@hmv.org.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Moinhos de Vento
• Investigators: Principal Investigator: Regis G Rosa, MD, PhD, Hospital Moinhos de Vento

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2022
• Primary Completion (Anticipated): November 15, 2023
• Study Completion (Anticipated): November 15, 2023

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: Pos-COVID Brasil 3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No