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
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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UNKNOWN
318 participants
OBSERVATIONAL
2022-02-15
2023-11-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by SAS-CoV-2.
COVID-19
SARS-CoV-2 infection
ARDS
Acute respiratory distress syndrome
Non-COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2.
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.
No interventions assigned to this group
Interventions
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COVID-19
SARS-CoV-2 infection
ARDS
Acute respiratory distress syndrome
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hospital Moinhos de Vento
OTHER
Responsible Party
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Principal Investigators
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Regis G Rosa, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Moinhos de Vento
Central Contacts
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Other Identifiers
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Pos-COVID Brasil 3
Identifier Type: -
Identifier Source: org_study_id
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