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

NCT ID: NCT05225194

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

318 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-11-15

Brief Summary

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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

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Conditions

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COVID-19 ARDS

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 ARDS survivors

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

COVID-19

Intervention Type OTHER

SARS-CoV-2 infection

ARDS

Intervention Type OTHER

Acute respiratory distress syndrome

Non-COVID-19 ARDS survivors

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

ARDS

Intervention Type OTHER

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.

No interventions assigned to this group

Interventions

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COVID-19

SARS-CoV-2 infection

Intervention Type OTHER

ARDS

Acute respiratory distress syndrome

Intervention Type OTHER

Eligibility Criteria

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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.


* 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.


* 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;
* 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


* 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


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Moinhos de Vento

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Regis G Rosa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Moinhos de Vento

Central Contacts

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Geraldine Trott, PhD

Role: CONTACT

+5551994407117

Other Identifiers

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Pos-COVID Brasil 3

Identifier Type: -

Identifier Source: org_study_id

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