COVID-19NCT05197647
Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Mild COVID-19 Patients in Brazil
An observational study of COVID-19 and Quality of Life, run by Hospital Moinhos de Vento at 14 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 patients with mild 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?
- Patients with symptomatic COVID-19 disease not requiring hospitalization.
- How many people
- 1,085 participants
- Where
- 14 sitesBrazil
- Study dates
- 25 Jan 2022to 20 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 with proven mild symptomatic COVID-19 disease not requiring hospitalization.
Who may be able to join
- Age ≥18 years;
- Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
- At least one of the following symptoms: fever, cough, sneezing, dyspnea, fatigue, smell alteration, rhinorrhea, sore throat, myalgia, arthralgia, diarrhea;
- Outpatient COVID-19 care at the moment of enrollment (without indication for in-hospital care).
Who cannot join
- Severe comorbidity with life expectancy less than 3 months;
- Absence of proxy for patients with communication difficulties;
- Absence of telephone contact;
- Refusal or withdrawal of agreement to participate;
- Previous enrollment in the study.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Brazil14 sites
Hospital Metropolitano Célio de Castro
Belo Horizonte, Minas Gerais
Instituto Horizonti
Belo Horizonte, Minas Gerais
Hospital do Coração do Mato Grosso do Sul
Campo Grande, Mato Grosso do Sul
Hospital Leo Orsi
Itapetininga, São Paulo
Instituto Procardio
Joinville, Santa Catarina
Hospital Universitário de Ponta Grossa
Ponta Grossa, Paraná
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul
Hospital Vila Nova
Porto Alegre, Rio Grande do Sul
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo
Clinica Silvestre Santé
Rio Branco, Acre
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo
Hospital do Coração
São Paulo, São Paulo
Hospital Santa Paula
São Paulo, São Paulo
Hospital Enseada Prime
Vitória, Espírito Santo
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 patients with mild COVID-19. Adult patients with symptomatic COVID-19 not requiring hospitalization will be followed through structured and centralized telephone interviews performed at 1, 3, 6, 9 and 12 months after enrollment.
- Conditions
- COVID-19, Quality of Life, Disability Physical, Disabilities Mental
- Being tested
- Patients with symptomatic COVID-19 disease not requiring hospitalization.
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with symptomatic COVID-19 disease not requiring hospitalization.Other
Patients with symptomatic COVID-19 disease not requiring hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Patients with mild COVID-19 | Patients with symptomatic COVID-19 disease not requiring hospitalization. Receives: Other: Patients with symptomatic COVID-19 disease not requiring hospitalization. |
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 (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 1, 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 hospitalizations
Incidence of all-cause hospitalizations
Measured: The outcome will be assessed at 1, 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 1, 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 COVID-19 diagnosis.
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 posted19 Jan 2022
- Study start25 Jan 2022
- Primary completion20 Dec 2023 (estimated)
- Study completion20 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
- 1,085 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Regis Rosa, MD, PhD, Principal investigator, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197647
- Sponsor's protocol ID
- Pos-COVID Brasil 2
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2022
- 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
Rover MM, Trott G, Scolari FL, Silva MMDD, Souza D, Santos RDRMD, Dagnino APA, Mesquita Neto J, Estivalete GP, Kozesinski-Nakatani AC, Marcolino MS, Barreto BB, Schvartzman PR, Antonio ACP, Robinson CC, Falavigna M, Biolo A, Polanczyk CA, Rosa RG. Health-Related Quality of Life and Long-Term Outcomes after Mildly Symptomatic COVID-19: The Post-COVID Brazil Study 2 Protocol. Arq Bras Cardiol. 2023 Sep;120(9):e20220835. doi: 10.36660/abc.20220835. English, Portuguese.
PubMed 37851732
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 Mild COVID-19 Patients in Brazil
- ClinicalTrials.gov ID
- NCT05197647
- Acronym / sponsor ID
- Pos-COVID Brasil 2
- Conditions
- COVID-19, Quality of Life, Disability Physical, Disabilities Mental
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,085 participants (actual)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 19 Jan 2022 (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 patients with mild COVID-19. Adult patients with symptomatic COVID-19 not requiring hospitalization will be followed through structured and centralized telephone interviews performed at 1, 3, 6, 9 and 12 months after enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with mild COVID-19 | – | Other: Patients with symptomatic COVID-19 disease not requiring hospitalization.Patients with symptomatic COVID-19 disease not requiring hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients survivors with proven mild symptomatic COVID-19 disease not requiring hospitalization.
Key inclusion criteria (4 listed)
- Age ≥18 years;
- Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
- At least one of the following symptoms: fever, cough, sneezing, dyspnea, fatigue, smell alteration, rhinorrhea, sore throat, myalgia, arthralgia, diarrhea;
- Outpatient COVID-19 care at the moment of enrollment (without indication for in-hospital care).
Key exclusion criteria (5 listed)
- Severe comorbidity with life expectancy less than 3 months;
- Absence of proxy for patients with communication difficulties;
- Absence of telephone contact;
- Refusal or withdrawal of agreement to participate;
- Previous enrollment in the study.
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 |
|---|---|---|
| Patients with symptomatic COVID-19 disease not requiring hospitalization.Patients with symptomatic COVID-19 disease not requiring hospitalization. | Other | Patients with mild COVID-19 |
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).
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 1, 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 hospitalizations
Time frame: The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.
Prevalence of prolonged COVID-19 symptoms
Time frame: The outcome will be assessed at 1, 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.
- Background: PubMed 37851732Rover MM, Trott G, Scolari FL, Silva MMDD, Souza D, Santos RDRMD, Dagnino APA, Mesquita Neto J, Estivalete GP, Kozesinski-Nakatani AC, Marcolino MS, Barreto BB, Schvartzman PR, Antonio ACP, Robinson CC, Falavigna M, Biolo A, Polanczyk CA, Rosa RG. Health-Related Quality of Life and Long-Term Outcomes after Mildly Symptomatic COVID-19: The Post-COVID Brazil Study 2 Protocol. Arq Bras Cardiol. 2023 Sep;120(9):e20220835. doi: 10.36660/abc.20220835. 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 Rosa, MD, PhD principal investigator
Hospital Moinhos de Vento
14 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 14 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 5 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 14 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 NCT05197647, 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.