COVID19 Hospitilized in Clinica Pasteur of Neuquen (Argentina)

NCT05087394 | Completed DMC

• 1 other identifier: COVIDPas1
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

retrospective cohort (non-experimental study) of COVID 19 patients assisted in hospitalization (severe and critical) between 2020 and 2021

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 28-day mortality

  defined as death ocurred within 28 days of admition to hospital

  From date of admition until the date of death from any cause, assessed up to 28 day

• Hospital mortality

  defined as death ocurred within hospitalization

  From date of admition until the date of death from any cause, assessed up to 52 weeks

Secondary Outcomes (1)

• Invasive Mechanical ventilation

  From date of admition until the date of equirement of invasive mechanical ventilation, assessed up to 21 day

Interventions

Comorbidities OTHER

Risk factors (comorbidities), requirements of respiratory suppot and chest imaging will are considered exposure for primary outcomes

Also known as: Oxigen requirement, Mechanical Ventilation, High flow nasal cannula, Chest CT scan, CT pulmonary angiogram (CTPA)

Eligibility Criteria

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

Study Population

Adult patients with severe or critical (according to NIH) COVID19 diseased admitted to Pasteur Clinic in 202 and 2021

You may qualify if:

• Adult patients (over 18 years old)
• Suffering from acute infection by SARS-Cov2, diagnosed by PCR-real time, detection of viral antigen, specific antibodies with or clinical epidemiological criteria
• Hospitalization defined by attending or referral physician (severe or critical according to NIH)

You may not qualify if:

• Patients under 18 years of age.
• Convalescent from acute SARS-Cov2 infection and without evidence of a new event reinfection.
• Outpatient management or hospitalization less than 24 hours for diagnosis and / or evaluation of severity or complications.

Sponsors & Collaborators

• Asociacion Latinoamericana de Torax: lead

Study Sites (1)

Pasteur Clinic

Neuquén, Nqn, 8300, Argentina

Location

Related Publications (9)

• 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

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

• Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response. JAMA. 2020 Apr 28;323(16):1545-1546. doi: 10.1001/jama.2020.4031. No abstract available.

  PMID: 32167538 BACKGROUND

• Working group for the surveillance and control of COVID-19 in Spain; Members of the Working group for the surveillance and control of COVID-19 in Spain. The first wave of the COVID-19 pandemic in Spain: characterisation of cases and risk factors for severe outcomes, as at 27 April 2020. Euro Surveill. 2020 Dec;25(50):2001431. doi: 10.2807/1560-7917.ES.2020.25.50.2001431.

  PMID: 33334400 BACKGROUND

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

• Aylward L, Liang W, Dong X, et al., World Health Organization W. Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19). WHO-China Jt Mission Coronavirus Dis 2019. 2020;1(16-24 February):1-40.

  BACKGROUND

• Lamfre L, Caro P, Hasdeu S, Horne F. Modelo de Proyección de Casos Esperados COVID-19 En Argentina 2020. Neuquen https://1331c255-c873-472c-8edd- 6738111a6c38.filesusr.com/ugd/d623b6_007bc0ad0898495882e61367e1d2644d.pdf.

  BACKGROUND

• Espinosa L, Ambort C, Vera M, et al. Documento de Comité Asesor de Ética de La Clínica Pasteur Para La Implementación Del Documento de Aspectos Éticos En La Pandemia de COVID19 En El Escenario de Recursos Escasos. Neuquen; 2020. https://drive.google.com/drive/u/0/folders/1BK1rSlpCR2KzydRxRp6KKUsqLezIKsAi

  BACKGROUND

• MSal Neuquen. ASPECTOS ÉTICOS EN LA ATENCIÓN DE LAS PERSONAS DURANTE LA PANDEMIA POR CORONAVIRUS ( SARS-CoV-2 ). Neuquen; 2020.

  BACKGROUND

Related Links

• Documento de Comité Asesor de Ética de La Clínica Pasteur Para La Implementación Del Documento de Aspectos Éticos En La Pandemia de COVID19 En El Escenario de Recursos Escasos. Neuquen; 2020

MeSH Terms

Conditions

COVID-19

Interventions

Comorbidity; Respiration, Artificial

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)

Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Gustavo Zabert, MD

  Clinica Pasteur

  PRINCIPAL INVESTIGATOR

• Ignacio Zabert, MD

  Clinica Pasteur

  STUDY DIRECTOR

• Ignacio Veltri, MD

  Clinica Pasteur

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Months
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 21, 2021
• Study Start: March 20, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 30, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

AR (1)