A Clinical Trial for Hospitalized Patients With COVID-19 in Ceará: ResCOVID Study

NCT ID: NCT04649827

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-02

Study Completion Date

2021-12-30

Brief Summary

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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

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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

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COVID-19

Keywords

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COVID-19 Hospitalization Public Health

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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COVID-19

Patients with confirmed COVID-19 by RT-PCR or serological test

Clinical Observation

Intervention Type OTHER

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.

Interventions

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Clinical Observation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed COVID-19

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Escola de Saúde Pública do Ceará

OTHER_GOV

Sponsor Role lead

Responsible Party

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Marcelo Alcantara Holanda

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcelo A Holanda, PHD

Role: PRINCIPAL_INVESTIGATOR

Escola Saude Publica

Locations

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Hospital Leonardo Da Vinci

Fortaleza, Ceará, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Jadson A' Franco

Role: CONTACT

Phone: +55853101

Email: [email protected]

Facility Contacts

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Marcelo A Holanda, PHD

Role: primary

Other Identifiers

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3.948.100

Identifier Type: -

Identifier Source: org_study_id