Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

2. února 2022 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Očekávaný)

318

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

N/A

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by SAS-CoV-2.
Jiný: COVID-19
SARS-CoV-2 infection
Jiný: ARDS
Acute respiratory distress syndrome
Non-COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2.
Jiný: 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 je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Diffusion capacity for carbon monoxide
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Physical functional status
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hospital Moinhos de Vento

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Očekávaný)

15. února 2022

Primární dokončení (Očekávaný)

15. listopadu 2023

Dokončení studie (Očekávaný)

15. listopadu 2023

Termíny zápisu do studia

První předloženo

1. února 2022

První předloženo, které splnilo kritéria kontroly kvality

2. února 2022

První zveřejněno (Aktuální)

4. února 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. února 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. února 2022

Naposledy ověřeno

1. ledna 2022

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Pos-COVID Brasil 3

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit