SARS-CoV 2EpiCoV-BrazilNCT04378582
Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU
An observational study of SARS-CoV 2 and Respiratory Distress Syndrome, Adult, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This is a case series of patients with COVID-19 admitted to the largest university hospital in Sao Paulo, Brazil, during the 2020 COVID-19 pandemic. Data will be collected prospectively and retrospectively. Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- SARS-CoV 2, Respiratory Distress Syndrome, Adult, Corona Virus Infection
- What is being tested?
- risk factors
- How many people
- 1,589 participants
- Where
- 1 siteBrazil
- Study dates
- 7 May 2020to 5 Aug 2020
- 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 14 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with confirmed COVID-19 by RT-PCR or sorological test, or suspected COVID-19, as defined by clinical history and course, who have negative RT-PCR or sorological test but where treated and cared for as COVID-19 patients, who are admitted to the ICU during the study period. Data will be collected prospectively for patients admitted to the ICU after the the date of study approval and retrospectively for patients admitted to the ICU during the COVID-19 epidemic in sao paulo, but before the study was initiated. A sample size of 300 patients was inittialy anticipated. As the epidemic in Sao Paulo grew fast, the hospital opened new ICU beds and the investigators reviewed the anticipated sample size to 500 patients. Given that the study has no risks for participants, and that informed consent was waived by the IRB, investigators intend to collect data about all patients with COVID-19 admitted to the ICUs during the study period, possibly more than the anticipated sample size.
Who may be able to join
- Being admitted to one of the COVID-19 ICUs during the study period
- Suspected or confirmed COVID-19
- Expected ICU stay greater than 24 hours
Who cannot join
- ICU Readmission during the same hospital stay (patients will be evaluated only during their first ICU stay)
Trial locations and contacts
1 site in 1 country.
About this study
This is a case series of patients with COVID-19 admitted to the largest university hospital in Sao Paulo, Brazil, during the 2020 COVID-19 pandemic. Data will be collected prospectively and retrospectively.
The main objective is to describe the characteristics of critically ill patients with COVID-19 and their clinical outcomes, and to identify risk factors associated with survival, to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.
Read the detailed description
In December 2019, an outbreak of Severe Acute Respiratory Syndrome (SARS) attributed to a new coronavirus, called SARS-CoV-2, was described in the Wuhan region of China. This SARS, caused by SARS-CoV-2 was called COVID-19, spread across the globe, causing millions of cases on all continents, and thousands of deaths, being characterized as a pandemic.
COVID-19 is characterized by a flu-like syndrome, with symptoms such as fever, cough, myalgia and gastrointestinal symptoms. Most cases are mild, some even asymptomatic, but approximately 15% of patients have more severe presentation, and approximately 5% are critical (7).
The acute respiratory failure of critically ill patients with COVID-19 has different aspects, including hypoxemia of difficult treatment, associated in some cases with clotting disorders, changes in immunity and inflammatory phenomena that pose challenges for the management of these patients, whose mortality can be high.
The Hospital das Clínicas da Faculdade de Medicina de São Paulo implemented an action plan that provides for the creation of 200 ICU beds to serve patients with COVID-19. Knowing the characteristics of critically ill patients with COVID-19 and their clinical outcomes is extremely important to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.
- Conditions
- SARS-CoV 2, Respiratory Distress Syndrome, Adult, Corona Virus Infection, Critical Illness
- Being tested
- risk factors
- Keywords
- Critical Care
- Medical subject headings
- Respiratory Distress Syndrome, Coronavirus Infections, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risk factorsOther
Also called demographics, comorbidities, mechanical ventilation parameters, need for advanced life support
This is an observational study, so there are no interventions. Investigators will collect data about demographics, comorbidities, and other risk factors such as severity of disease at admission, need for advanced life support, need for invasive mechanical ventilation and ventilator parameters on day1 of mechanical ventilation or ICU admission as potentially association with survival
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 confirmed | Patients with confirmed COVID-19 by RT-PCR or serological test Receives: Other: risk factors | |
| COVID-19 suspected | Patients suspected COVID-19, as defined by clinical history and course, who have negative RT-PCR or serological test but where treated and cared for as COVID-19 patients Receives: Other: risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU survival at 28 days
the proportion of patients who survive to ICU discharge or for 28 days in the ICU
Measured: 28 days
Secondary outcomes (4)
Hospital survival at 60 days
the proportion of patients who survive to hospital discharge or for 60 days in the hospital
Measured: 60 days
Duration of mechanical ventilation
Number of days under invasive ventilatory support
Measured: 28 days
Need for renal replacement therapy
Proportion of patients who received renal replacement therapy during the ICU stay
Measured: 28 days
Complications during the ICU stay
percentage of patients who developed complications during the ICU stay: thromboembolic events, ventilator associated pneumonia, secondary infections, cardiovascular complications
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start7 May 2020
- Primary completion28 Jul 2020
- Study completion5 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV 2Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 1,589 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Carvalho Ferreira, University of Sao Paulo General Hospital
- Investigators
- Juliana C Ferreira, MD, Principal investigator, University of Sao Paulo - hospital das Clínicas da faculdade de medicina da USP (HCFMUSP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378582
- Sponsor's protocol ID
- 31382620.0.0000.0068
- Acronym
- EpiCoV-Brazil
- Status last verified
- Aug 2020
- First submitted
- 5 May 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators haven't developed a plan for sharing, but would be open to share unidentified data for research or public health purposes
Publications
Taniguchi LU, Aliberti MJR, Dias MB, Jacob-Filho W, Avelino-Silva TJ. Calculating Route: Functional Trajectories and Long-Term Outcomes in Survivors of Severe COVID-19. J Nutr Health Aging. 2023;27(12):1168-1173. doi: 10.1007/s12603-023-2036-4.
PubMed 38151867Taniguchi LU, Avelino-Silva TJ, Dias MB, Jacob-Filho W, Aliberti MJR; COVID-19 and Frailty (CO-FRAIL) Study Group and EPIdemiology of Critical COVID-19 (EPICCoV) Study Group, for COVID Hospital das Clinicas, University of Sao Paulo Medical School (HCFMUSP) Study Group. Patient-Centered Outcomes Following COVID-19: Frailty and Disability Transitions in Critical Care Survivors. Crit Care Med. 2022 Jun 1;50(6):955-963. doi: 10.1097/CCM.0000000000005488. Epub 2022 Jan 26.
PubMed 35081061Ferreira JC, Ho YL, Besen BAMP, Malbuisson LMS, Taniguchi LU, Mendes PV, Costa ELV, Park M, Daltro-Oliveira R, Roepke RML, Silva JM Jr, Carmona MJC, Carvalho CRR; EPICCoV Study Group; Hirota A, Kanasiro AK, Crescenzi A, Fernandes AC, Miethke-Morais A, Bellintani AP, Canasiro AR, Carneiro BV, Zanbon BK, Batista BPSN, Nicolao BR, Besen BAMP, Biselli B, Macedo BR, Toledo CMG, Pompilio CE, Carvalho CRR, Mol CG, Stipanich C, Bueno CG, Garzillo C, Tanaka C, Forte DN, Joelsons D, Robira D, Costa ELV, Silva EM Junior, Regalio FA, Segura GC, Marcelino GB, Louro GS, Ho YL, Ferreira IA, Gois JO, Silva JM Junior, Reusing JO Junior, Ribeiro JF, Ferreira JC, Galleti KV, Silva KR, Isensee LP, Oliveira LS, Taniguchi LU, Letaif LS, Lima LT, Park LY, Chaves L Netto, Nobrega LC, Haddad L, Hajjar L, Malbouisson LM, Pandolfi MCA, Park M, Carmona MJC, Andrade MCPH, Santos MM, Bateloche MP, Suiama MA, Oliveira MF, Sousa ML, Louvaes M, Huemer N, Mendes P, Lins PRG, Santos PG, Moreira PFP, Guazzelli RM, Reis RB, Oliveira RD, Roepke RML, Pedro RAM, Kondo R, Rached SZ, Fonseca SRS, Borges TS, Ferreira T, Cobello V Junior, Sales VVT, Ferreira WSC. Characteristics and outcomes of patients with COVID-19 admitted to the ICU in a university hospital in Sao Paulo, Brazil - study protocol. Clinics (Sao Paulo). 2020;75:e2294. doi: 10.6061/clinics/2020/e2294. Epub 2020 Aug 26.
PubMed 32876113
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU
- ClinicalTrials.gov ID
- NCT04378582
- Acronym / sponsor ID
- EpiCoV-Brazil / 31382620.0.0000.0068
- Conditions
- SARS-CoV 2, Respiratory Distress Syndrome, Adult, Corona Virus Infection, Critical Illness
- Keywords
- Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,589 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 7 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.
This is a case series of patients with COVID-19 admitted to the largest university hospital in Sao Paulo, Brazil, during the 2020 COVID-19 pandemic. Data will be collected prospectively and retrospectively.
The main objective is to describe the characteristics of critically ill patients with COVID-19 and their clinical outcomes, and to identify risk factors associated with survival, to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.
Detailed description
In December 2019, an outbreak of Severe Acute Respiratory Syndrome (SARS) attributed to a new coronavirus, called SARS-CoV-2, was described in the Wuhan region of China. This SARS, caused by SARS-CoV-2 was called COVID-19, spread across the globe, causing millions of cases on all continents, and thousands of deaths, being characterized as a pandemic.
COVID-19 is characterized by a flu-like syndrome, with symptoms such as fever, cough, myalgia and gastrointestinal symptoms. Most cases are mild, some even asymptomatic, but approximately 15% of patients have more severe presentation, and approximately 5% are critical (7).
The acute respiratory failure of critically ill patients with COVID-19 has different aspects, including hypoxemia of difficult treatment, associated in some cases with clotting disorders, changes in immunity and inflammatory phenomena that pose challenges for the management of these patients, whose mortality can be high.
The Hospital das Clínicas da Faculdade de Medicina de São Paulo implemented an action plan that provides for the creation of 200 ICU beds to serve patients with COVID-19. Knowing the characteristics of critically ill patients with COVID-19 and their clinical outcomes is extremely important to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 confirmed | – | Other: risk factorsPatients with confirmed COVID-19 by RT-PCR or serological test |
| COVID-19 suspected | – | Other: risk factorsPatients suspected COVID-19, as defined by clinical history and course, who have negative RT-PCR or serological test but where treated and cared for as COVID-19 patients |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with confirmed COVID-19 by RT-PCR or sorological test, or suspected COVID-19, as defined by clinical history and course, who have negative RT-PCR or sorological test but where treated and cared for as COVID-19 patients, who are admitted to the ICU during the study period. Data will be collected prospectively for patients admitted to the ICU after the the date of study approval and retrospectively for patients admitted to the ICU during the COVID-19 epidemic in sao paulo, but before the study was initiated. A sample size of 300 patients was inittialy anticipated. As the epidemic in Sao Paulo grew fast, the hospital opened new ICU beds and the investigators reviewed the anticipated sample size to 500 patients. Given that the study has no risks for participants, and that informed consent was waived by the IRB, investigators intend to collect data about all patients with COVID-19 admitted to the ICUs during the study period, possibly more than the anticipated sample size.
Key inclusion criteria (3 listed)
- Being admitted to one of the COVID-19 ICUs during the study period
- Suspected or confirmed COVID-19
- Expected ICU stay greater than 24 hours
Key exclusion criteria (1 listed)
- ICU Readmission during the same hospital stay (patients will be evaluated only during their first ICU stay)
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 |
|---|---|---|
| risk factorsAlso: demographics, comorbidities, mechanical ventilation parameters, need for advanced life supportThis is an observational study, so there are no interventions. Investigators will collect data about demographics, comorbidities, and other risk factors such as severity of disease at admission, need for advanced life support, need for invasive mechanical ventilation and ventilator parameters on day1 of mechanical ventilation or ICU admission as potentially association with survival | Other | COVID-19 confirmed, COVID-19 suspected |
Primary outcome
ICU survival at 28 days
Time frame: 28 days
the proportion of patients who survive to ICU discharge or for 28 days in the ICU
4 secondary outcomes
Hospital survival at 60 days
Time frame: 60 days
Duration of mechanical ventilation
Time frame: 28 days
Need for renal replacement therapy
Time frame: 28 days
Complications during the ICU stay
Time frame: 28 days
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 26 Aug 2020.
- Derived from this study: PubMed 38151867Taniguchi LU, Aliberti MJR, Dias MB, Jacob-Filho W, Avelino-Silva TJ. Calculating Route: Functional Trajectories and Long-Term Outcomes in Survivors of Severe COVID-19. J Nutr Health Aging. 2023;27(12):1168-1173. doi: 10.1007/s12603-023-2036-4.
- Derived from this study: PubMed 35081061Taniguchi LU, Avelino-Silva TJ, Dias MB, Jacob-Filho W, Aliberti MJR; COVID-19 and Frailty (CO-FRAIL) Study Group and EPIdemiology of Critical COVID-19 (EPICCoV) Study Group, for COVID Hospital das Clinicas, University of Sao Paulo Medical School (HCFMUSP) Study Group. Patient-Centered Outcomes Following COVID-19: Frailty and Disability Transitions in Critical Care Survivors. Crit Care Med. 2022 Jun 1;50(6):955-963. doi: 10.1097/CCM.0000000000005488. Epub 2022 Jan 26.
- Derived from this study: PubMed 32876113Ferreira JC, Ho YL, Besen BAMP, Malbuisson LMS, Taniguchi LU, Mendes PV, Costa ELV, Park M, Daltro-Oliveira R, Roepke RML, Silva JM Jr, Carmona MJC, Carvalho CRR; EPICCoV Study Group; Hirota A, Kanasiro AK, Crescenzi A, Fernandes AC, Miethke-Morais A, Bellintani AP, Canasiro AR, Carneiro BV, Zanbon BK, Batista BPSN, Nicolao BR, Besen BAMP, Biselli B, Macedo BR, Toledo CMG, Pompilio CE, Carvalho CRR, Mol CG, Stipanich C, Bueno CG, Garzillo C, Tanaka C, Forte DN, Joelsons D, Robira D, Costa ELV, Silva EM Junior, Regalio FA, Segura GC, Marcelino GB, Louro GS, Ho YL, Ferreira IA, Gois JO, Silva JM Junior, Reusing JO Junior, Ribeiro JF, Ferreira JC, Galleti KV, Silva KR, Isensee LP, Oliveira LS, Taniguchi LU, Letaif LS, Lima LT, Park LY, Chaves L Netto, Nobrega LC, Haddad L, Hajjar L, Malbouisson LM, Pandolfi MCA, Park M, Carmona MJC, Andrade MCPH, Santos MM, Bateloche MP, Suiama MA, Oliveira MF, Sousa ML, Louvaes M, Huemer N, Mendes P, Lins PRG, Santos PG, Moreira PFP, Guazzelli RM, Reis RB, Oliveira RD, Roepke RML, Pedro RAM, Kondo R, Rached SZ, Fonseca SRS, Borges TS, Ferreira T, Cobello V Junior, Sales VVT, Ferreira WSC. Characteristics and outcomes of patients with COVID-19 admitted to the ICU in a university hospital in Sao Paulo, Brazil - study protocol. Clinics (Sao Paulo). 2020;75:e2294. doi: 10.6061/clinics/2020/e2294. Epub 2020 Aug 26.
- Individual participant dataSharing planned: Undecided. The investigators haven't developed a plan for sharing, but would be open to share unidentified data for research or public health purposes
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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.
Juliana C Ferreira, MD principal investigator
University of Sao Paulo - hospital das Clínicas da faculdade de medicina da USP (HCFMUSP)
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 SARS-CoV 2 and Respiratory Distress Syndrome, Adult, run by University of Sao Paulo General Hospital 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 1 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 26 Aug 2020. 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?
ICU survival at 28 days (time frame: 28 days). 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 NCT04378582, which also lists 3 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 26 Aug 2020.