COVID-19NCT05225194
Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil
An observational study of COVID-19 and ARDS, run by Hospital Moinhos de Vento.
Trial summary
The present multicenter prospective observational study aims to assess the long-term effects of COVID-19 on patients with Acute Respiratory Distress Syndrome (ARDS). This is a hybrid design study with components of cohort and case-control designs. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- COVID-19 and ARDS
- How many people
- 318 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2022to 15 Nov 2023
- 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
- Adult, Older adult
Study population: Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization
Who may be able to join
- Age ≥18 years;
- Hospitalization due to COVID-19;
- Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
- Diagnosis of ARDS during hospitalization according to the Berlin definition;
- Expected to survive and be discharged directly home from the hospital.
- Age ≥18 years;
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- Hospitalization;
- Diagnosis of ARDS during hospitalization according to the Berlin definition;
- Expected to survive and be discharged directly home from the hospital.
- Age ≥18 years;
- Family member of a enrolled participant (either from the COVID-19 ARDS cohort or from the non-COVID-19 ARDS cohort)
Who cannot join
- Severe comorbidity with life expectancy less than 3 months;
- Unavailability to attend the study follow-up appointment;
- Death during hospitalization;
- Absence of proxy for patients with communication difficulties;
- Refusal or withdrawal of agreement to participate.
- COHORT OF SURVIVORS OF ARDS CAUSED BY OTHER ETIOLOGIES NOT ASSOCIATED WITH COVID-19
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- Severe comorbidity with life expectancy less than 3 months;
- Unavailability to attend the study follow-up appointment;
- Death during hospitalization;
- History of SARS-CoV-2 infection within the last 12 months;
- Absence of proxy for patients with communication difficulties;
- Refusal or withdrawal of agreement to participate.
- FAMILY CONTROLS
- Severe comorbidity with life expectancy less than 3 months;
- Unavailability to attend the study follow-up appointment;
- History of SARS-CoV-2 infection within the last 12 months;
- History of non-elective hospitalization due to medical condition within the last 12 months;
- Refusal or withdrawal of agreement to participate.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Study for the Assessment of Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil
The present multicenter prospective observational study aims to assess the long-term effects of COVID-19 on patients with Acute Respiratory Distress Syndrome (ARDS).
This is a hybrid design study with components of cohort and case-control designs. Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization will be followed up for a period of 6 months.
- Being tested
- COVID-19, ARDS
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19Other
SARS-CoV-2 infection
ARDSOther
Acute respiratory distress syndrome
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 ARDS survivors | Survivors of hospitalization due to ARDS caused by SAS-CoV-2. Receives: Other: COVID-19; Other: ARDS | |
| Non-COVID-19 ARDS survivors | Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2. Receives: Other: ARDS | |
| Family controls | Family controls of participants with ARDS (either due to COVID-19 or other etiologies) without history of COVID-19 or hospitalization in the last 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion capacity for carbon monoxide
Proportion of participants with diffusion capacity for carbon monoxide < 80% of predicted
Measured: The outcome will be assessed 6 months after enrollment
Secondary outcomes (19)
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 and 6 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 and 6 months after enrollment
Muscular function and strength
Muscular function and strength as assessed by Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire. Scale scores range from 0 (best) to 10 (worst)
Measured: The outcome will be assessed at 3 and 6 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 at 3 and 6 months after enrollment
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 at 3 and 6 months after enrollment
Radiologic patterns of intersticial lung disease
Radiologic patterns of intersticial lung disease as assessed by high resolution computed tomography chest scan.
Measured: The outcome will be assessed at 6 months after enrollment
Radiologic patterns of myocarditis sequalae
Radiologic patterns of myocarditis sequalae as assessed by cardiac magnetic resonance imaging
Measured: The outcome will be assessed at 6 months after enrollment
Radiologic patterns of sarcopenia
Radiologic patterns of sarcopenia as assessed by high resolution computed tomography chest scan.
Measured: The outcome will be assessed at 6 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 and 6 months after enrollment
Incidence of thromboembolic events
Incidence of thromboembolic events (composite endpoint of pulmonary embolism and deep venous thrombosis)
Measured: The outcome will be assessed at 3 and 6 months after enrollment
Incidence of all-cause mortality
Incidence of all-cause mortality
Measured: The outcome will be assessed at 3 and 6 months after enrollment
Percentage of predicted peak oxygen consumption
Percentage of predicted peak oxygen consumption as assessed by treadmill cardiopulmonary exercise cardiopulmonary exercise
Measured: The outcome will be assessed at 6 months after enrollment
Peak oxygen consumption
Peak oxygen as assessed by treadmill cardiopulmonary exercise
Measured: The outcome will be assessed at 6 months after enrollment
Peak oxygen pulse
Peak oxygen pulse as assessed by treadmill cardiopulmonary exercise
Measured: The outcome will be assessed at 6 months after enrollment
Oxygen uptake efficiency slope
Oxygen uptake efficiency slope as assessed by treadmill cardiopulmonary exercise
Measured: The outcome will be assessed at 6 months after enrollment
Minute ventilation/carbon dioxide production slope ratio
Minute ventilation/carbon dioxide production slope as assessed by treadmill cardiopulmonary exercise
Measured: The outcome will be assessed at 6 months after enrollment
Forced vital capacity
Forced expiratory capacity as assessed by spirometry
Measured: The outcome will be assessed at 6 months after enrollment
Forced expiratory volume in one second
Forced expiratory volume in one second as assessed by spirometry
Measured: The outcome will be assessed at 6 months after enrollment
Forced expiratory volume in one second/ Forced vital capacity ratio
Forced expiratory volume in one second/ Forced vital capacity ratio as assessed by spirometry
Measured: The outcome will be assessed at 6 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 posted4 Feb 2022
- Study start15 Feb 2022 (estimated)
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 318 participants (estimated)
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
- NCT05225194
- Sponsor's protocol ID
- Pos-COVID Brasil 3
- Status last verified
- Jan 2022
- First submitted
- 1 Feb 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for the Assessment of Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil
- ClinicalTrials.gov ID
- NCT05225194
- Acronym / sponsor ID
- Pos-COVID Brasil 3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- 15 Feb 2022 (estimated)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 4 Feb 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 multicenter prospective observational study aims to assess the long-term effects of COVID-19 on patients with Acute Respiratory Distress Syndrome (ARDS).
This is a hybrid design study with components of cohort and case-control designs. Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization will be followed up for a period of 6 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 ARDS survivors | – | Other: COVID-19, Other: ARDSSurvivors of hospitalization due to ARDS caused by SAS-CoV-2. |
| Non-COVID-19 ARDS survivors | – | Other: ARDSSurvivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2. |
| Family controls | – | –Family controls of participants with ARDS (either due to COVID-19 or other etiologies) without history of COVID-19 or hospitalization in the last 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization
Key inclusion criteria (11 listed)
- Age ≥18 years;
- Hospitalization due to COVID-19;
- Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
- Diagnosis of ARDS during hospitalization according to the Berlin definition;
- Expected to survive and be discharged directly home from the hospital.
Key exclusion criteria (18 listed)
- Severe comorbidity with life expectancy less than 3 months;
- Unavailability to attend the study follow-up appointment;
- Death during hospitalization;
- 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-19SARS-CoV-2 infection | Other | COVID-19 ARDS survivors |
| ARDSAcute respiratory distress syndrome | Other | COVID-19 ARDS survivors, Non-COVID-19 ARDS survivors |
Primary outcome
Diffusion capacity for carbon monoxide
Time frame: The outcome will be assessed 6 months after enrollment
Proportion of participants with diffusion capacity for carbon monoxide < 80% of predicted
19 secondary outcomes
Physical functional status
Time frame: The outcome will be assessed at 3 and 6 months after enrollment
Instrumental Activities of Daily Living
Time frame: The outcome will be assessed at 3 and 6 months after enrollment
Muscular function and strength
Time frame: The outcome will be assessed at 3 and 6 months after enrollment
Score of dyspnea
Time frame: The outcome will be assessed at 3 and 6 months after enrollment
Utility score of health related quality of life
Time frame: The outcome will be assessed at 3 and 6 months after enrollment
Radiologic patterns of intersticial lung disease
Time frame: The outcome will be assessed at 6 months after enrollment
Radiologic patterns of myocarditis sequalae
Time frame: The outcome will be assessed at 6 months after enrollment
Radiologic patterns of sarcopenia
Time frame: The outcome will be assessed at 6 months after enrollment
Incidence of major cardiovascular events
Time frame: The outcome will be assessed at 3 and 6 months after enrollment
Incidence of thromboembolic events
Time frame: The outcome will be assessed at 3 and 6 months after enrollment
Incidence of all-cause mortality
Time frame: The outcome will be assessed at 3 and 6 months after enrollment
Percentage of predicted peak oxygen consumption
Time frame: The outcome will be assessed at 6 months after enrollment
Peak oxygen consumption
Time frame: The outcome will be assessed at 6 months after enrollment
Peak oxygen pulse
Time frame: The outcome will be assessed at 6 months after enrollment
Oxygen uptake efficiency slope
Time frame: The outcome will be assessed at 6 months after enrollment
Minute ventilation/carbon dioxide production slope ratio
Time frame: The outcome will be assessed at 6 months after enrollment
Forced vital capacity
Time frame: The outcome will be assessed at 6 months after enrollment
Forced expiratory volume in one second
Time frame: The outcome will be assessed at 6 months after enrollment
Forced expiratory volume in one second/ Forced vital capacity ratio
Time frame: The outcome will be assessed at 6 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 4 Feb 2022.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and ARDS, run by Hospital Moinhos de Vento.
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 11 inclusion and 18 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 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Geraldine Trott, PhD (+5551994407117, geraldine.trott@hmv.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusion capacity for carbon monoxide (time frame: The outcome will be assessed 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2022.