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

Hospital Moinhos de Vento

Status: Unknown

Conditions: COVID-19; ARDS

Treatments: Other: ARDS; Other: COVID-19

Study type: Observational

Funder types: Other

Identifiers

NCT05225194

Pos-COVID Brasil 3

Details and patient eligibility

About

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.

Enrollment: 318 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

318 participants in 3 patient groups

COVID-19 ARDS survivors

Description:

Survivors of hospitalization due to ARDS caused by SAS-CoV-2.

Treatment:

Other: ARDS

Other: COVID-19

Non-COVID-19 ARDS survivors

Description:

Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2.

Treatment:

Other: ARDS

Family controls

Description:

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.