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

2 lutego 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Oczekiwany)

318

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie dotyczy

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by SAS-CoV-2.
Inny: COVID-19
SARS-CoV-2 infection
Inny: ARDS
Acute respiratory distress syndrome
Non-COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Diffusion capacity for carbon monoxide
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Physical functional status
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hospital Moinhos de Vento

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Oczekiwany)

15 lutego 2022

Zakończenie podstawowe (Oczekiwany)

15 listopada 2023

Ukończenie studiów (Oczekiwany)

15 listopada 2023

Daty rejestracji na studia

Pierwszy przesłany

1 lutego 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 lutego 2022

Pierwszy wysłany (Rzeczywisty)

4 lutego 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 lutego 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lutego 2022

Ostatnia weryfikacja

1 stycznia 2022

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Pos-COVID Brasil 3

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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