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

2. Februar 2022 aktualisiert von: Hospital Moinhos de Vento

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

318

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

N/A

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by SAS-CoV-2.
Sonstiges: COVID-19
SARS-CoV-2 infection
Sonstiges: ARDS
Acute respiratory distress syndrome
Non-COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Diffusion capacity for carbon monoxide
Zeitfenster: The outcome will be assessed 6 months after enrollment
Proportion of participants with diffusion capacity for carbon monoxide < 80% of predicted
The outcome will be assessed 6 months after enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Physical functional status
Zeitfenster: The outcome will be assessed at 3 and 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 3 and 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 3 and 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 3 and 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 3 and 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 3 and 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 3 and 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 3 and 6 months after enrollment
Incidence of all-cause mortality
The outcome will be assessed at 3 and 6 months after enrollment
Percentage of predicted peak oxygen consumption
Zeitfenster: The outcome will be assessed at 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 6 months after enrollment
Peak oxygen as assessed by treadmill cardiopulmonary exercise
The outcome will be assessed at 6 months after enrollment
Peak oxygen pulse
Zeitfenster: The outcome will be assessed at 6 months after enrollment
Peak oxygen pulse as assessed by treadmill cardiopulmonary exercise
The outcome will be assessed at 6 months after enrollment
Oxygen uptake efficiency slope
Zeitfenster: The outcome will be assessed at 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 6 months after enrollment
Forced expiratory capacity as assessed by spirometry
The outcome will be assessed at 6 months after enrollment
Forced expiratory volume in one second
Zeitfenster: The outcome will be assessed at 6 months after enrollment
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
Zeitfenster: The outcome will be assessed at 6 months after enrollment
Forced expiratory volume in one second/ Forced vital capacity ratio as assessed by spirometry
The outcome will be assessed at 6 months after enrollment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hospital Moinhos de Vento

Ermittler

  • Hauptermittler: Regis G Rosa, MD, PhD, Hospital Moinhos de Vento

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

15. Februar 2022

Primärer Abschluss (Voraussichtlich)

15. November 2023

Studienabschluss (Voraussichtlich)

15. November 2023

Studienanmeldedaten

Zuerst eingereicht

1. Februar 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Februar 2022

Zuerst gepostet (Tatsächlich)

4. Februar 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Februar 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Februar 2022

Zuletzt verifiziert

1. Januar 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Pos-COVID Brasil 3

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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