COVID-19ResCOVIDNCT04649827
A Clinical Trial for Hospitalized Patients With COVID-19 in Ceará: ResCOVID Study
An observational study of COVID-19, run by Escola de Saúde Pública do Ceará at 1 site in Brazil.
Trial summary
This is a case series of patients with COVID-19 admitted to the northeast Brazil region, in a referenced hospital for COVID-19, during the 2020 COVID-19 pandemic. Data will be collected prospectively and retrospectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Clinical Observation
- How many people
- 3,000 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Apr 2020to 30 Dec 2021
- 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: Patients with confirmed COVID-19 by RT-PCR or sorological test, who are admitted at the referenced hospital in Fortaleza, Brazil. Data will be collected prospectively for patients admitted to the ICU after the date of study approval and retrospectively for patients admitted to the ICU during the COVID-19 epidemic in Fortaleza, but before the study was initiated. A sample size of 1000 patients was initially anticipated. As the epidemic in Fortaleza grew fast and it is one of the most affected regions in Brazil. The present study has no risks for participants since there are no new therapy or treatment to be tested. The investigators intend to collect data about all patients with COVID-19 admitted into the Hospital and at the ICU during the study period, possibly more than the anticipated sample size.
Who may be able to join
- Confirmed COVID-19
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Leonardo Da Vinci
Fortaleza, Ceará, 60135-285
Marcelo A Holanda, PHD, +558531011398, cep@esp.ce.gov.br
About this study
Official title: SARS-CoV-2 Epidemiology Study at e Referenced Hospital in Fortaleza, Brazil: ResCOVID Study
This is a case series of patients with COVID-19 admitted to the northeast Brazil region, in a referenced hospital for COVID-19, 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 guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.
Read the detailed description
The world's population has been recently dealing with a new infectious disease, SARS-CoV-2 epidemic, which was first reported in December 2019 in Wuhan, China. The virus transmission was rapidly spread around the globe and the World Health Organization declared it as a public health emergency and it has been reported that SARS-CoV-2 is related to high morbidity and mortality rates.
The total number of infected patients has risen fastly and at the end of February 2020, the first case in Brazil was confirmed, suggesting that the SARS-CoV-2 is a pandemic situation.
The clinical aspect of SARS-CoV-2 ranges from pneumonia to critically ill cases, including clinical treatment, mechanical ventilation, and SARS.
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 higher than expected.
The Public Health School in Fortaleza, Ceara, Brazil, implemented an action plan that provides several actions against COVID-19, including a specialized hospital and crew to treat these patients. 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
- COVID-19
- Being tested
- Clinical Observation
- Keywords
- COVID-19, Hospitalization, Public Health
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical ObservationOther
This is an observational study, so there are no interventions. Investigators will collect data about demographics, comorbidities, medications, and other risk factors such as the severity of disease at admission, need for advanced life support, need for invasive mechanical ventilation and main outcomes during hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Patients with confirmed COVID-19 by RT-PCR or serological test Receives: Other: Clinical Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU outcome
the proportion of patients who survive to ICU discharge
Measured: up to 60 days
Secondary outcomes (3)
Hospital outcome
the proportion of patients who survive to hospitalization
Measured: up to 90 days
Mechanical ventilation
Mechanical ventilation time
Measured: up to 60 days
Hospital complications
percentage of patients who developed complications during the hospitalization, both at ICU and during total hospitalization.
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start2 Apr 2020
- Primary completion30 Jun 2020
- Study completion30 Dec 2021 (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
- Case only
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola de Saúde Pública do Ceará
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marcelo Alcantara Holanda, Escola de Saúde Pública do Ceará
- Investigators
- Marcelo A Holanda, PHD, Principal investigator, Escola Saude Publica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649827
- Sponsor's protocol ID
- 3.948.100
- Acronym
- ResCOVID
- Status last verified
- Nov 2020
- First submitted
- 26 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Epidemiology Study at e Referenced Hospital in Fortaleza, Brazil: ResCOVID Study
- ClinicalTrials.gov ID
- NCT04649827
- Acronym / sponsor ID
- ResCOVID / 3.948.100
- Conditions
- COVID-19
- Keywords
- COVID-19, Hospitalization, Public Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Escola de Saúde Pública do CearáOther government
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 2 Dec 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 northeast Brazil region, in a referenced hospital for COVID-19, 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 guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.
Detailed description
The world's population has been recently dealing with a new infectious disease, SARS-CoV-2 epidemic, which was first reported in December 2019 in Wuhan, China. The virus transmission was rapidly spread around the globe and the World Health Organization declared it as a public health emergency and it has been reported that SARS-CoV-2 is related to high morbidity and mortality rates.
The total number of infected patients has risen fastly and at the end of February 2020, the first case in Brazil was confirmed, suggesting that the SARS-CoV-2 is a pandemic situation.
The clinical aspect of SARS-CoV-2 ranges from pneumonia to critically ill cases, including clinical treatment, mechanical ventilation, and SARS.
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 higher than expected.
The Public Health School in Fortaleza, Ceara, Brazil, implemented an action plan that provides several actions against COVID-19, including a specialized hospital and crew to treat these patients. 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
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Other: Clinical ObservationPatients with confirmed COVID-19 by RT-PCR or serological test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed COVID-19 by RT-PCR or sorological test, who are admitted at the referenced hospital in Fortaleza, Brazil. Data will be collected prospectively for patients admitted to the ICU after the date of study approval and retrospectively for patients admitted to the ICU during the COVID-19 epidemic in Fortaleza, but before the study was initiated. A sample size of 1000 patients was initially anticipated. As the epidemic in Fortaleza grew fast and it is one of the most affected regions in Brazil. The present study has no risks for participants since there are no new therapy or treatment to be tested. The investigators intend to collect data about all patients with COVID-19 admitted into the Hospital and at the ICU during the study period, possibly more than the anticipated sample size.
Key inclusion criteria (1 listed)
- Confirmed COVID-19
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Clinical ObservationThis is an observational study, so there are no interventions. Investigators will collect data about demographics, comorbidities, medications, and other risk factors such as the severity of disease at admission, need for advanced life support, need for invasive mechanical ventilation and main outcomes during hospitalization. | Other | COVID-19 |
Primary outcome
ICU outcome
Time frame: up to 60 days
the proportion of patients who survive to ICU discharge
3 secondary outcomes
Hospital outcome
Time frame: up to 90 days
Mechanical ventilation
Time frame: up to 60 days
Hospital complications
Time frame: up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- 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.
Marcelo A Holanda, PHD principal investigator
Escola Saude Publica
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 COVID-19, run by Escola de Saúde Pública do Ceará 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 1 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: status not confirmed, as of the sponsor's last update on 2 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jadson A' Franco (+55853101 ext. 1406, cep@esp.ce.gov.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU outcome (time frame: up to 60 days). 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 2 Dec 2020.