Clinical trial NCT04649827: A Clinical Trial for Hospitalized Patients With COVID-19 in Ceará: ResCOVID Study
Official title: SARS-CoV-2 Epidemiology Study at e Referenced Hospital in Fortaleza, Brazil: ResCOVID Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
Hospitalization
Public Health
Lead sponsor: Escola de Saúde Pública do Ceará
Sponsor class: OTHER_GOV
First posted: 2020-12-02
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Confirmed COVID-19

Exclusion Criteria:

* N/A

Primary outcomes:
measure: ICU outcome
timeFrame: up to 60 days
Secondary outcomes:
measure: Hospital outcome
timeFrame: up to 90 days
measure: Mechanical ventilation
timeFrame: up to 60 days
measure: Hospital complications
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Hospital Leonardo Da Vinci
state: Ceara
Study officials:
affiliation: Escola Saude Publica
name: Marcelo A Holanda, PHD
role: PRINCIPAL_INVESTIGATOR
References: