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

Study Overview
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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.

Official Title
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SARS-CoV-2 Epidemiology Study at e Referenced Hospital in Fortaleza, Brazil: ResCOVID Study

Conditions
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COVID-19

Intervention / Treatment
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* Other: Clinical Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed COVID-19 Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19<br>Patients with confirmed COVID-19 by RT-PCR or serological test | Other: Clinical Observation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU outcome | the proportion of patients who survive to ICU discharge | up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital outcome | the proportion of patients who survive to hospitalization | up to 90 days | 
| Mechanical ventilation | Mechanical ventilation time | up to 60 days | 
| Hospital complications | percentage of patients who developed complications during the hospitalization, both at ICU and during total hospitalization. | up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Hospitalization, Public Health