Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil
2. februar 2022 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Forventet)
318
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Geraldine Trott, PhD
- Telefonnummer: +5551994407117
- E-mail: geraldine.trott@hmv.org.br
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
N/A
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by SAS-CoV-2.
|
SARS-CoV-2 infection
Acute respiratory distress syndrome
|
|
Non-COVID-19 ARDS survivors
Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diffusion capacity for carbon monoxide
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical functional status
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Regis G Rosa, MD, PhD, Hospital Moinhos de Vento
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
15. februar 2022
Primær færdiggørelse (Forventet)
15. november 2023
Studieafslutning (Forventet)
15. november 2023
Datoer for studieregistrering
Først indsendt
1. februar 2022
Først indsendt, der opfyldte QC-kriterier
2. februar 2022
Først opslået (Faktiske)
4. februar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. februar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. februar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Coronavirus infektioner
- Coronaviridae infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Luftvejsinfektioner
- Luftvejssygdomme
- Respirationsforstyrrelser
- Lungebetændelse, viral
- Lungebetændelse
- Lungesygdomme
- Spædbarn, Nyfødt, Sygdomme
- Lungeskade
- Spædbørn, for tidligt fødte, Sygdomme
- COVID-19
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, nyfødt
- Akut lungeskade
Andre undersøgelses-id-numre
- Pos-COVID Brasil 3
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