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

NCT04362969 | Unknown

• 1 other identifier: 001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

• Clinical characteristics of patients with COVID-19

  To know the clinical characteristics of patients with COVID-19 treated in hospitals in Guayaquil, Ecuador.

  4 weeks

Secondary Outcomes (3)

• Prognosis of patients, in terms of need for admission to intensive care, use of mechanical ventilation or death

  4 weeks

• Clinical characteristics of the patients with the worst prognosis

  4 weeks

• Relationship between the different treatments and the prognosis

  4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult population hospitalized by COVID-19 in public and private hospitals in the city of Guayaquil, Ecuador.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Universidad Catolica Santiago de Guayaquil: collaborator

Study Sites (1)

GastroMuñoz

Guayaquil, Guayas, Ecuador

Location

Related Publications (13)

• Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.

  PMID: 32087114 BACKGROUND

• 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

  BACKGROUND

• Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

  PMID: 32109013 BACKGROUND

• Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 BACKGROUND

• Ki M; Task Force for 2019-nCoV. Epidemiologic characteristics of early cases with 2019 novel coronavirus (2019-nCoV) disease in Korea. Epidemiol Health. 2020;42:e2020007. doi: 10.4178/epih.e2020007. Epub 2020 Feb 9.

  PMID: 32035431 BACKGROUND

• Wang Y, Lu X, Li Y, Chen H, Chen T, Su N, Huang F, Zhou J, Zhang B, Yan F, Wang J. Clinical Course and Outcomes of 344 Intensive Care Patients with COVID-19. Am J Respir Crit Care Med. 2020 Jun 1;201(11):1430-1434. doi: 10.1164/rccm.202003-0736LE. No abstract available.

  PMID: 32267160 BACKGROUND

• Goyal P, Choi JJ, Pinheiro LC, Schenck EJ, Chen R, Jabri A, Satlin MJ, Campion TR Jr, Nahid M, Ringel JB, Hoffman KL, Alshak MN, Li HA, Wehmeyer GT, Rajan M, Reshetnyak E, Hupert N, Horn EM, Martinez FJ, Gulick RM, Safford MM. Clinical Characteristics of Covid-19 in New York City. N Engl J Med. 2020 Jun 11;382(24):2372-2374. doi: 10.1056/NEJMc2010419. Epub 2020 Apr 17. No abstract available.

  PMID: 32302078 BACKGROUND

• Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.

  PMID: 32250385 BACKGROUND

• 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.

  BACKGROUND

• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

  PMID: 22797452 BACKGROUND

• Toh CH, Hoots WK; SSC on Disseminated Intravascular Coagulation of the ISTH. The scoring system of the Scientific and Standardisation Committee on Disseminated Intravascular Coagulation of the International Society on Thrombosis and Haemostasis: a 5-year overview. J Thromb Haemost. 2007 Mar;5(3):604-6. doi: 10.1111/j.1538-7836.2007.02313.x. Epub 2006 Nov 10. No abstract available.

  PMID: 17096704 BACKGROUND

• Menendez R, Torres A, Aspa J, Capelastegui A, Prat C, Rodriguez de Castro F; Sociedad Espanola de Neumologia y Cirugia Toracica. [Community acquired pneumonia. New guidelines of the Spanish Society of Chest Diseases and Thoracic Surgery (SEPAR)]. Arch Bronconeumol. 2010 Oct;46(10):543-58. doi: 10.1016/j.arbres.2010.06.014. Epub 2010 Sep 15. No abstract available. Spanish.

  PMID: 20832928 BACKGROUND

• Shah BA, Ahmed W, Dhobi GN, Shah NN, Khursheed SQ, Haq I. Validity of pneumonia severity index and CURB-65 severity scoring systems in community acquired pneumonia in an Indian setting. Indian J Chest Dis Allied Sci. 2010 Jan-Mar;52(1):9-17.

  PMID: 20364609 BACKGROUND

Study Officials

• JORGE CARRIEL

  Hospital Clínico San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JORGE CARRIEL

CONTACT

0034657666872; jorge.carriel84@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Locations

EC (1)