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

NCT04649827 | Unknown DMC

• 1 other identifier: 3.948.100
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; Hospitalization; Public Health

Outcome Measures

Primary Outcomes (1)

• ICU outcome

  the proportion of patients who survive to ICU discharge

  up to 60 days

Secondary Outcomes (3)

• Hospital outcome

  up to 90 days

• Mechanical ventilation

  up to 60 days

• Hospital complications

  up to 90 days

Study Arms (1)

COVID-19

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

Other: Clinical Observation

Interventions

Clinical Observation 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.

COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Confirmed COVID-19

You may not qualify if:

• N/A

Sponsors & Collaborators

• Escola de Saúde Pública do Ceará: lead

Study Sites (1)

Hospital Leonardo Da Vinci

Fortaleza, Ceará, 60135-285, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Marcelo A Holanda, PHD

  Escola Saude Publica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jadson A' Franco

CONTACT

+55853101; cep@esp.ce.gov.br

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 2, 2020
• Study Start: April 2, 2020
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2021
• Last Updated: December 2, 2020

Record last verified: 2020-11

Locations

BR (1)