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COVID-EC Study: Clinical Characteristics of Patients With COVID-19 in Guayaquil, Ecuador

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ClinicalTrials.gov Identifier: NCT04362969
Recruitment Status : Not yet recruiting
First Posted : April 27, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Universidad Catolica Santiago de Guayaquil
Information provided by (Responsible Party):
Jorge Carriel M., Hospital San Carlos, Madrid

Brief Summary:

In December 2019, an outbreak of pneumonia of initially unknown cause was detected in Wuhan (Hubei, China), and it was quickly determined that it was caused by a new coronavirus, that is, the SARS-CoV- 2 virus, causing the disease called COVID-19. Since then, the outbreak has spread to 5 continents, affecting 185 countries or regions, with more than 2,500,000 confirmed cases as of April 21, 2020. Ecuador, the 9th country according to territorial extension, and the 7th according to the number of inhabitants in South America, is the 4th country with the highest number of cases in that region of the world, only behind Brazil, Peru and Chile. According to data from the Ministry of Public Health (MSP) of Ecuador, as of April 20, 2020, the National Institute for Public Health Research (INSPI) has registered 33,279 samples, of which 10,128 are positive for SARS-CoV-2. By far, the province of Guayas where Guayaquil is located, the main city in terms of number of inhabitants of the country, is the region with the highest number of affected, with 6921 confirmed cases and 6274 with suspicion.

Given the importance of this infection, the severity in some cases, its rapid distribution, and the differences in the Ecuadorian population with respect to the other countries where infected patients have been reported, the investigators consider that an updated analysis of cases, taking as a reference, patients seen in various hospitals of the city of Guayaquil can help identify the clinical characteristics and severity of the disease.


Condition or disease
COVID

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Characteristics of Patients With SARS-CoV-2 (COVID-19) Infection in Guayaquil, Ecuador: COVID-EC Study
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020



Primary Outcome Measures :
  1. Clinical characteristics of patients with COVID-19 [ Time Frame: 4 weeks ]
    To know the clinical characteristics of patients with COVID-19 treated in hospitals in Guayaquil, Ecuador.


Secondary Outcome Measures :
  1. Prognosis of patients, in terms of need for admission to intensive care, use of mechanical ventilation or death [ Time Frame: 4 weeks ]
    Establish the prognosis of patients, in terms of need for admission to intensive care, use of mechanical ventilation or death.

  2. Clinical characteristics of the patients with the worst prognosis [ Time Frame: 4 weeks ]
    To determine the clinical characteristics of the patients with the worst prognosis.

  3. Relationship between the different treatments and the prognosis [ Time Frame: 4 weeks ]
    Relate, at least retrospectively, the relationship that may exist between the different treatments and the prognosis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult population hospitalized by COVID-19 in public and private hospitals in the city of Guayaquil, Ecuador.
Criteria

Inclusion Criteria:

  • Patients 18 years or older who required hospitalization.
  • Confirmed diagnosis of COVID-19 by positive nasopharyngeal exudate for SARS-CoV-2.
  • Probable diagnosis of COVID-19, according to WHO criteria.

Exclusion Criteria:

- Patients with negative nasopharyngeal exudate for SARS-CoV-2.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362969


Contacts
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Contact: JORGE CARRIEL 0034657666872 jorge.carriel84@gmail.com

Locations
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Ecuador
GastroMuñoz
Guayaquil, Guayas, Ecuador
Contact: Roberto Muñoz, MD    593999605614      
Sponsors and Collaborators
Hospital San Carlos, Madrid
Universidad Catolica Santiago de Guayaquil
Investigators
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Principal Investigator: JORGE CARRIEL Hospital Clínico San Carlos, Madrid
Publications:
Boletín No 053 con fecha 20/04/2020 del Ministerio de Salud Pública sobre COVID-2019 Ecuador [Internet]. 2020 [cited 2020 Apr 21]. Available from: https://www.salud.gob.ec/wp-content/uploads/2020/04/Boletin-053-AM_Nacional.pdf
OMS. Protocolo de investigación de los primeros casos y sus contactos directos (FFX) de la enfermedad por Coronavirus 2019 (COVID-19). 2020;2:1-83.

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Responsible Party: Jorge Carriel M., Physician, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT04362969    
Other Study ID Numbers: 001
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No