COVID-19NCT05165979
Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe COVID-19 Patients in Brazil
An observational study of COVID-19 and Quality of Life, run by Hospital Moinhos de Vento at 24 sites in Brazil.
Trial summary
The present prospective cohort study aims to assess factors associated with of one-year health-related quality of life and physical, cognitive and mental health outcomes among adult survivors of hospitalization for COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Quality of Life, Disability Physical
- What is being tested?
- Hospitalization due to COVID-19
- How many people
- 650 participants
- Where
- 24 sitesBrazil
- Study dates
- 21 Dec 2021to 1 Jul 2024
- 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 patients survivors of hospitalization due to proven COVID-19 disease.
Who may be able to join
- Age ≥18 years;
- Symptomatic COVID-19 disease within the last 14 days;
- Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within the last 14 days;
- Need of hospitalization (duration ≥ 48 hours).
Who cannot join
- Severe comorbidity with life expectancy less than 3 months;
- Death during hospitalization;
- Absence of telephone contact;
- Absence of proxy for patients with communication difficulties;
- Refusal or withdrawal of agreement to participate;
- Previous enrollment in the study.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Brazil24 sites
Hospital das clínicas da UFMG
Belo Horizonte, Minas Gerais
Hospital Emydio Germano
Belo Horizonte, Minas Gerais
Hospital Metropolitano Célio de Castro
Belo Horizonte, Minas Gerais
Instituto Horizonti
Belo Horizonte, Minas Gerais
Hospital do Coração de Mato Grosso do Sul
Campo Grande, Mato Grosso do Sul
Hospital Universitário de Canoas
Canoas, Rio Grande do Sul
Santa Casa de Curitiba
Curitiba, Paraná
Hospital Nelson Cornetet
Guaíba, Rio Grande do Sul
Hospital Leo Orsi
Itapetininga, São Paulo
Hospital Universitário de Londrina
Londrina, Paraná
Hospital das Clínicas de Passo Fundo
Passo Fundo, Rio Grande do Sul
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul
Hospital universitário de Ponta Grossa
Ponta Grossa, Paraná
Fundação Universitária Instituto de Cardiologia
Porto Alegre, Rio Grande do Sul
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul
Hospital moinhos de Vento
Porto Alegre, Rio Grande do Sul
Hospital Vila Nova
Porto Alegre, Rio Grande do Sul
Cemetron
Porto Velho, Rondônia
Hospital Beneficência Portuguesa de Ribeirão Preto
Ribeirão Preto, São Paulo
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo
Hospital Beneficência Portuguesa de São Paulo
São Paulo, São Paulo
Hospital do Coração
São Paulo, São Paulo
Hospital SEPACO
São Paulo, São Paulo
About this study
The present prospective cohort study aims to assess factors associated with of one-year health-related quality of life and physical, cognitive and mental health outcomes among adult survivors of hospitalization for COVID-19. Adult patients requiring hospitalization due to COVID-19 disease will be followed through structured and centralized telephone interviews performed at 3, 6, 9 and 12 months after enrollment.
- Conditions
- COVID-19, Quality of Life, Disability Physical, Disabilities Mental
- Being tested
- Hospitalization due to COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospitalization due to COVID-19Other
Hospitalization due to COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized COVID-19 patients | Hospitalized COVID-19 patients Receives: Other: Hospitalization due to COVID-19 |
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.
Measured: The outcome will be assessed 12 months after enrollment.
Secondary outcomes (12)
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 at 3, 6, and 9 months after enrollment.
Incidence of all-cause mortality
Incidence of all-cause mortality
Measured: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Incidence of major cardiovascular events
Incidence of major cardiovascular events (composite endpoint of non-fatal stroke, non-fatal acute myocardial infarction, or cardiovascular death)
Measured: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Incidence of rehospitalizations
Incidence of all-cause rehospitalizations
Measured: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Prevalence of prolonged COVID-19 symptoms
Prevalence of prolonged COVID-19 symptoms defined as presence of dyspnea, cough, fatigue, muscular weakness, chest discomfort, joint pain, anosmia, hair loss, brain fog, insomnia, among others)
Measured: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Prevalence of cognitive dysfunction
Prevalence of cognitive dysfunction as assessed by the Telephone Interview for Cognitive Status (TICS-m; scores ranging from 0 to 50 with lower scores indicating worse cognition).
Measured: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Prevalence of anxiety and depression symptoms
Prevalence of anxiety and depression symptoms as assessed by 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 at 3, 6, 9, and 12 months after enrollment.
Prevalence of posttraumatic stress disorder symptoms
Prevalence of posttraumatic stress disorder symptoms as assessed by the Impact Event Scale-6 (scores range from 0 to 24 with higher scores indicating worse symptoms).
Measured: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Physical functional status
Physical functional status as assessed by the modified Barthel index (score ranges from 0 to 100; higher scores indicate less functional dependence).
Measured: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
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 at 3, 6, 9, and 12 months after enrollment.
Incidence of return to work or study
Incidence of return to work or study among patients that were working or studying at the moment of hospitalization.
Measured: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Incidence of new symptomatic COVID-19 infection
Incidence of new symptomatic COVID-19 infection defined as recurrence of COVID-19-related symptoms with a positive PCR test for SARS-CoV-2 90 days after the index infection.
Measured: The outcome will be assessed at 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.
- First posted21 Dec 2021
- Study start21 Dec 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Regis G Rosa, MD, PhD, Principal investigator, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165979
- Sponsor's protocol ID
- Pos-COVID Brasil 1
- Status last verified
- Nov 2023
- First submitted
- 20 Dec 2021
- Last updated
- 7 Nov 2023
- 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
Trott G, Scolari FL, Rover MM, Silva MMDD, Souza D, Santos RDRMD, Schardosim RFC, Rech GS, Mesquita Neto J, Estivalete GP, Freitas HJM, Itaqui CR, Kozesinski-Nakatani AC, Biolo A, Marcolino MS, Barreto BB, Schvartzman PR, Antonio ACP, Robinson CC, Falavigna M, Polanczyk CA, Rosa RG. Long-term Health-Related Quality of Life and Outcomes after Hospitalization for COVID-19 in Brazil: Post-COVID Brazil 1 Study Protocol. Arq Bras Cardiol. 2023 Nov;120(11):e20230378. doi: 10.36660/abc.20230378. English, Portuguese.
PubMed 37991122
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe COVID-19 Patients in Brazil
- ClinicalTrials.gov ID
- NCT05165979
- Acronym / sponsor ID
- Pos-COVID Brasil 1
- Conditions
- COVID-19, Quality of Life, Disability Physical, Disabilities Mental
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 21 Dec 2021 (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.
The present prospective cohort study aims to assess factors associated with of one-year health-related quality of life and physical, cognitive and mental health outcomes among adult survivors of hospitalization for COVID-19. Adult patients requiring hospitalization due to COVID-19 disease will be followed through structured and centralized telephone interviews performed at 3, 6, 9 and 12 months after enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized COVID-19 patients | – | Other: Hospitalization due to COVID-19Hospitalized COVID-19 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients survivors of hospitalization due to proven COVID-19 disease.
Key inclusion criteria (4 listed)
- Age ≥18 years;
- Symptomatic COVID-19 disease within the last 14 days;
- Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within the last 14 days;
- Need of hospitalization (duration ≥ 48 hours).
Key exclusion criteria (6 listed)
- Severe comorbidity with life expectancy less than 3 months;
- Death during 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 |
|---|---|---|
| Hospitalization due to COVID-19Hospitalization due to COVID-19 | Other | Hospitalized COVID-19 patients |
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.
12 secondary outcomes
Utility score of health related quality of life at 3, 6, and 9 months
Time frame: The outcome will be assessed at 3, 6, and 9 months after enrollment.
Incidence of all-cause mortality
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Incidence of major cardiovascular events
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Incidence of rehospitalizations
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Prevalence of prolonged COVID-19 symptoms
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Prevalence of cognitive dysfunction
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Prevalence of anxiety and depression symptoms
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Prevalence of posttraumatic stress disorder symptoms
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Physical functional status
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Instrumental Activities of Daily Living
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Incidence of return to work or study
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Incidence of new symptomatic COVID-19 infection
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 37991122Trott G, Scolari FL, Rover MM, Silva MMDD, Souza D, Santos RDRMD, Schardosim RFC, Rech GS, Mesquita Neto J, Estivalete GP, Freitas HJM, Itaqui CR, Kozesinski-Nakatani AC, Biolo A, Marcolino MS, Barreto BB, Schvartzman PR, Antonio ACP, Robinson CC, Falavigna M, Polanczyk CA, Rosa RG. Long-term Health-Related Quality of Life and Outcomes after Hospitalization for COVID-19 in Brazil: Post-COVID Brazil 1 Study Protocol. Arq Bras Cardiol. 2023 Nov;120(11):e20230378. doi: 10.36660/abc.20230378. English, Portuguese.
- 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.
Regis G Rosa, MD, PhD principal investigator
Hospital Moinhos de Vento
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Quality of Life, run by Hospital Moinhos de Vento at 24 sites 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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?
Results are not available in the source record.
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 NCT05165979, which also lists 1 linked publication.
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 7 Nov 2023.