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

2 de febrero de 2022 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Anticipado)

318

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

N/A

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by SAS-CoV-2.
Otro: COVID-19
SARS-CoV-2 infection
Otro: ARDS
Acute respiratory distress syndrome
Non-COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Diffusion capacity for carbon monoxide
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Physical functional status
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hospital Moinhos de Vento

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

15 de febrero de 2022

Finalización primaria (Anticipado)

15 de noviembre de 2023

Finalización del estudio (Anticipado)

15 de noviembre de 2023

Fechas de registro del estudio

Enviado por primera vez

1 de febrero de 2022

Primero enviado que cumplió con los criterios de control de calidad

2 de febrero de 2022

Publicado por primera vez (Actual)

4 de febrero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de febrero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

2 de febrero de 2022

Última verificación

1 de enero de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Pos-COVID Brasil 3

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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