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

COVID-19 Clinical Trial

— ResCOVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04649827
• Other study ID #: 3.948.100
• Status: Recruiting
• Start date: April 2, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2020
• Source: Escola de Saúde Pública do Ceará
• Contact: Jadson A' Franco
• Phone: +55853101
• Email: cep[@]esp.ce.gov.br
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed COVID-19

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Leonardo Da Vinci	Fortaleza	Ceara

Sponsors (1)

Lead Sponsor	Collaborator
Escola de Saúde Pública do Ceará

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU outcome	the proportion of patients who survive to ICU discharge	up to 60 days
Secondary	Hospital outcome	the proportion of patients who survive to hospitalization	up to 90 days
Secondary	Mechanical ventilation	Mechanical ventilation time	up to 60 days
Secondary	Hospital complications	percentage of patients who developed complications during the hospitalization, both at ICU and during total hospitalization.	up to 90 days