Quality of Life and Long-term Outcomes After Hospitalization for COVID-19
NCT ID: NCT04376658
Last Updated: 2022-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1508 participants
OBSERVATIONAL
2020-07-15
2022-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1 (Coalition I)
Adult hospitalized patients with proven or suspected SARS-Cov-2 infection with up to 4L/minute oxygen supply through nasal catheter.
COVID-19 Severity
Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death
Cohort 2 (Coalition II)
Adult hospitalized patients with proven or suspected SARS-Cov-2 infection needing oxygen supplementation \> 4L/min on nasal catheter or HFNC or NIV or MV or ECMO.
COVID-19 Severity
Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death
Cohort 3 (Coalition III)
Adult hospitalized patients with proven or suspected SARS-Cov-2 infection with moderate or severe ARDS according to the Berlin definition
COVID-19 Severity
Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death
Cohort 4 (Coalition IV)
Adult hospitalized patients with proven SARS-Cov-2 infection and D-dimer above the upper limit of the normal range
COVID-19 Severity
Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death
Cohort 5 (Coalition VI)
Adult hospitalized patients with proven SARS-Cov-2, needing oxygen supplementation to maintain SpO2 \> 93%, and two or more of the following inflammatory tests: D-dimer \> 1,000 ng/mL; C reactive protein (CRP) \> 5 mg/dL; Ferritin \> 300 mg/dL; Lactate dehydrogenase (LDH) \> upper limit of normal
COVID-19 Severity
Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death
Interventions
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COVID-19 Severity
Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death
Eligibility Criteria
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Inclusion Criteria
* Hospitalization due to proven or suspected SARS-CoV-2 infection
* Meeting eligibility criteria for Coalition Covid-19 Brazil randomized clinical trials
Exclusion Criteria
* Absence of telephone contact
* Absence of proxy for patients with communication difficulties
* Refusal or withdrawal of agreement to participate
18 Years
ALL
No
Sponsors
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Hospital Israelita Albert Einstein
OTHER
Hospital Sirio-Libanes
OTHER
Hospital do Coracao
OTHER
Hospital Alemão Oswaldo Cruz
OTHER
Beneficência Portuguesa de São Paulo
OTHER
Brazilian Clinical Research Institute
OTHER
Brazilian Research In Intensive Care Network
NETWORK
Hospital Moinhos de Vento
OTHER
Responsible Party
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Locations
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Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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References
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Rosa RG, Robinson CC, Veiga VC, Cavalcanti AB, Azevedo LCP, Machado FR, Berwanger O, Avezum A, Lopes RD, Lisboa TC, Teixeira C, Zampieri FG, Tomazini BM, Kawano-Dourado L, Schneider D, Souza D, Santos RDRMD, Silva SSD, Trott G, Gimenes BDP, Souza AP, Barroso BM, Costa LS, Brognoli LG, Pelliccioli MP, Studier NDS, Schardosim RFC, Haubert TA, Pallaoro VEL, Oliveira DM, Velho PI, Medeiros GS, Gazzana MB, Zavascki AP, Pitrez PM, Oliveira RP, Polanczyk CA, Nasi LA, Hammes LS, Falavigna M. Quality of life and long-term outcomes after hospitalization for COVID-19: Protocol for a prospective cohort study (Coalition VII). Rev Bras Ter Intensiva. 2021 Jan-Mar;33(1):31-37. doi: 10.5935/0103-507X.20210003.
Rosa RG, Cavalcanti AB, Azevedo LCP, Veiga VC, de Souza D, Dos Santos RDRM, Schardosim RFC, Rech GS, Trott G, Schneider D, Robinson CC, Haubert TA, Pallaoro VEL, Brognoli LG, de Souza AP, Costa LS, Barroso BM, Pelliccioli MP, Gonzaga J, Studier NDS, Dagnino APA, Neto JM, da Silva SS, Gimenes BDP, Dos Santos VB, Estivalete GPM, Pellegrino CM, Polanczyk CA, Kawano-Dourado L, Tomazini BM, Lisboa TC, Teixeira C, Zampieri FG, Zavascki AP, Gersh BJ, Avezum A, Machado FR, Berwanger O, Lopes RD, Falavigna M. Association between acute disease severity and one-year quality of life among post-hospitalisation COVID-19 patients: Coalition VII prospective cohort study. Intensive Care Med. 2023 Feb;49(2):166-177. doi: 10.1007/s00134-022-06953-1. Epub 2023 Jan 3.
Related Links
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Study Protocol
Other Identifiers
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Coalition COVID-19: Long-term
Identifier Type: -
Identifier Source: org_study_id
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