NCT04376658

Brief Summary

The present study aims to assess the determinants of health-related quality of life and long-term outcomes among survivors of hospitalization for Covid-19 in Brazil. The investigators will conduct a multicenter prospective cohort study nested in randomized clinical trials (coalition Covid-19 Brazil initiative) originally designed to assess the effects of specific Covid-19 treatments. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed up for a period of one year by means of structured telephone interviews. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. Secondary outcomes include all-cause mortality, rehospitalizations, return to work or study, physical functional status assessed by the Lawton \& Brody Instrumental Activities of Daily Living Scale, dyspnea assessed by the modified medical research council dyspnea scale, need of long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, and symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-revised.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,508

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2022

Completed
Last Updated

July 6, 2022

Status Verified

June 1, 2022

Enrollment Period

1.7 years

First QC Date

May 4, 2020

Last Update Submit

June 30, 2022

Conditions

Quality of LifeLong-term OutcomesCoronavirus Infection

Outcome Measures

Primary Outcomes (1)

  • One-year utility score of health-related quality of life

    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 12 months after enrollment.

Secondary Outcomes (10)

  • Incidence of all-cause mortality

    The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

  • Incidence of rehospitalizations

    The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

  • Percentage of return to work or study

    The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

  • Score of Instrumental Activities of Daily Living

    The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

  • Score of dyspnea

    The outcome will be assessed 3, 6, 9, and 12 months after enrollment.

  • +5 more secondary outcomes

Study Arms (5)

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.

Other: COVID-19 Severity

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.

Other: COVID-19 Severity

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

Other: COVID-19 Severity

Cohort 4 (Coalition IV)

Adult hospitalized patients with proven SARS-Cov-2 infection and D-dimer above the upper limit of the normal range

Other: COVID-19 Severity

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

Other: COVID-19 Severity

Interventions

COVID-19 SeverityOTHER

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 1 (Coalition I)Cohort 2 (Coalition II)Cohort 3 (Coalition III)Cohort 4 (Coalition IV)Cohort 5 (Coalition VI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection

You may qualify if:

  • Patients aged 18 years and older
  • Hospitalization due to proven or suspected SARS-CoV-2 infection
  • Meeting eligibility criteria for Coalition Covid-19 Brazil randomized clinical trials

You may not qualify if:

  • Death during the hospitalization
  • Absence of telephone contact
  • Absence of proxy for patients with communication difficulties
  • Refusal or withdrawal of agreement to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 33886851BACKGROUND

  • 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.

    PMID: 36594987DERIVED

Related Links

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 6, 2020

Study Start

July 15, 2020

Primary Completion

March 11, 2022

Study Completion

March 11, 2022

Last Updated

July 6, 2022

Record last verified: 2022-06

Locations

BR(1)