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

Hospital Moinhos de Vento318 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

318

Conditions

COVID-19 ARDS

Interventions

COVID-19OTHER

SARS-CoV-2 infection

ARDSOTHER

Acute respiratory distress syndrome

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

Central Contacts

Geraldine Trott, PhD

CONTACT

+5551994407117 geraldine.trott@hmv.org.br

Data from ClinicalTrials.gov

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