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

• Conditions: COVID-19
• Interventions: Other: Clinical Observation

• Registration Number: NCT04649827
• Lead Sponsor: Escola de Saúde Pública do Ceará

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.

Study Timeline

• Study Start: 2020-04-02
• Primary Completion: 2020-06-30
• Status Verified: 2020-11
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-12-01
• Last Update Submitted: 2020-12-01
• Study First Posted: 2020-12-02
• Last Update Posted: 2020-12-02
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Confirmed COVID-19

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19	Clinical Observation	Patients with confirmed COVID-19 by RT-PCR or serological test

Primary Outcome Measures

Name	Time	Method
ICU outcome	up to 60 days	the proportion of patients who survive to ICU discharge

Secondary Outcome Measures

Name	Time	Method
Hospital outcome	up to 90 days	the proportion of patients who survive to hospitalization
Mechanical ventilation	up to 60 days	Mechanical ventilation time
Hospital complications	up to 90 days	percentage of patients who developed complications during the hospitalization, both at ICU and during total hospitalization.

Trial Locations

Locations (1)

Hospital Leonardo Da Vinci; 🇧🇷 Fortaleza, Ceara, Brazil