Quality of LifeNCT04376658

Quality of Life and Long-term Outcomes After Hospitalization for COVID-19

An observational study of Quality of Life and Long-term Outcomes, run by Hospital Moinhos de Vento at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Quality of Life, Long-term Outcomes, Coronavirus Infection
What is being tested?: COVID-19 Severity
How many people: 1,508 participants
Where: 1 siteBrazil
Study dates: 15 Jul 2020to 11 Mar 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul

Other trials in Brazil

About this study

Official title: Assessment of Health-related Quality of Life and Long-term Outcomes After Hospitalization for COVID-19: A Multicenter Prospective Cohort Study

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.

Conditions: Quality of Life, Long-term Outcomes, Coronavirus Infection
Being tested: COVID-19 Severity
Medical subject headings: Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04376658
Study group	Role	What they receive
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. Receives: 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. Receives: 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 Receives: 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 Receives: 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 Receives: Other: COVID-19 Severity

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: The outcome will be assessed 12 months after enrollment.

Secondary outcomes (10)

Incidence of all-cause mortality
Incidence of all-cause mortality.
Measured: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Incidence of rehospitalizations
Incidence of all-cause rehospitalizations.
Measured: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Percentage of return to work or study
Percentage of return to work or study among patients that were working or studying at the moment of hospitalization.
Measured: 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 using the Lawton \& Brody Instrumental Activities of Daily Living Scale (the score ranges from 0 to 8, with higher scores indicating less dependence).
Measured: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Score of dyspnea
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.
Measured: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.
Percentage of long-term ventilatory support need
Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.
Measured: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Symptoms of anxiety and depression
The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).
Measured: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Symptoms of posttraumatic stress disorder
The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms).
Measured: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Utility score of health-related quality of life at 3, 6, and 9 months
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).
Measured: The outcome will be assessed 3, 6, and 9 months after enrollment.
Score of self-rated health
The outcome will be assessed using the visual analogue scale of the Brazilian version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health).
Measured: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202011 Mar 2022

First posted6 May 2020
Study start15 Jul 2020
Primary completion11 Mar 2022
Study completion11 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Quality of LifeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,508 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04376658
Sponsor's protocol ID: Coalition COVID-19: Long-term
Status last verified: Jun 2022
First submitted: 4 May 2020
Last updated: 6 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.

Publications

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.
PubMed 33886851
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.
PubMed 36594987

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Health-related Quality of Life and Long-term Outcomes After Hospitalization for COVID-19: A Multicenter Prospective Cohort Study
ClinicalTrials.gov ID: NCT04376658
Acronym / sponsor ID: Coalition COVID-19: Long-term
Conditions: Quality of Life, Long-term Outcomes, Coronavirus Infection
Study type: Observational
Recruitment status: Completed
Enrolment: 1,508 participants (actual)
Lead sponsor: Hospital Moinhos de VentoUniversity, hospital or other
Collaborators: Hospital Israelita Albert Einstein, Hospital Sirio-Libanes, Hospital do Coracao, Hospital Alemão Oswaldo Cruz, Beneficência Portuguesa de São Paulo, Brazilian Clinical Research Institute, Brazilian Research In Intensive Care Network
Study start: 15 Jul 2020 (actual)
Primary completion: 11 Mar 2022 (actual)
Study completion: 11 Mar 2022 (actual)
First posted: 6 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 5

Arm	Type	Receives
Cohort 1 (Coalition I)	–	Other: COVID-19 SeverityAdult hospitalized patients with proven or suspected SARS-Cov-2 infection with up to 4L/minute oxygen supply through nasal catheter.
Cohort 2 (Coalition II)	–	Other: COVID-19 SeverityAdult 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.
Cohort 3 (Coalition III)	–	Other: COVID-19 SeverityAdult hospitalized patients with proven or suspected SARS-Cov-2 infection with moderate or severe ARDS according to the Berlin definition
Cohort 4 (Coalition IV)	–	Other: COVID-19 SeverityAdult hospitalized patients with proven SARS-Cov-2 infection and D-dimer above the upper limit of the normal range
Cohort 5 (Coalition VI)	–	Other: COVID-19 SeverityAdult 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
COVID-19 SeverityDisease 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	Other	Cohort 1 (Coalition I), Cohort 2 (Coalition II), Cohort 3 (Coalition III), Cohort 4 (Coalition IV), Cohort 5 (Coalition VI)

Primary outcome

One-year utility score of health-related quality of life
Time frame: The outcome will be assessed 12 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).

10 secondary outcomes

Incidence of all-cause mortality
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Incidence of rehospitalizations
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Percentage of return to work or study
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Score of Instrumental Activities of Daily Living
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Score of dyspnea
Time frame: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.
Percentage of long-term ventilatory support need
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Symptoms of anxiety and depression
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Symptoms of posttraumatic stress disorder
Time frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.
Utility score of health-related quality of life at 3, 6, and 9 months
Time frame: The outcome will be assessed 3, 6, and 9 months after enrollment.
Score of self-rated health
Time frame: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
Background: PubMed 33886851Rosa 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.
Derived from this study: PubMed 36594987Rosa 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.
Study ProtocolLink provided by the sponsor.
Individual participant dataSharing planned: Undecided. The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life and Long-term Outcomes, run by Hospital Moinhos de Vento at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

One-year utility score of health-related quality of life (time frame: The outcome will be assessed 12 months after enrollment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04376658, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.