COVID19 Hospitilized in Clinica Pasteur of Neuquen (Argentina)

NCT ID: NCT05087394

Last Updated: 2023-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-20

Study Completion Date

2022-01-30

Brief Summary

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

Detailed Description

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Consecutive patients with acute infection by SARS-COV2 and severe or critical COVID19 disease, or acute complications, hospitalized in the Pasteur Clinic of Neuquén city from the beginning of the pandemic in the region until December 31, 2021. Data were obtained retrospectively from information registered simultaneously with hospitalization in three databases (RedCap, DataTech and Excel).

. Inclusion criteria

* 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
* Hospitalized defined by attending physicians or referral (severe or critical according to NIH) Exclusion criteria
* Patients under 18 years of age.
* Convalescent from acute SARS-Cov2 infection and without evidence of a new event of reinfection.
* Outpatient management or hospitalization less than 24 hours for diagnosis and / or evaluation of severity or complications. Sample Selection Method First patient was registered at the beginning of the pandemic in the region March 20, 2020) and is expected to recruit the las patient diagnosed in December 31, 2021.

The recruitment is consecutive without other selection criteria.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Comorbidities

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

Intervention Type OTHER

Other Intervention Names

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Oxigen requirement Mechanical Ventilation High flow nasal cannula Chest CT scan CT pulmonary angiogram (CTPA)

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Asociacion Latinoamericana de Torax

INDUSTRY

Sponsor Role lead

Responsible Party

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Gustavo Zabert, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gustavo Zabert, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Pasteur

Ignacio Zabert, MD

Role: STUDY_DIRECTOR

Clinica Pasteur

Ignacio Veltri, MD

Role: STUDY_DIRECTOR

Clinica Pasteur

Locations

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Pasteur Clinic

Neuquén, Nqn, Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type BACKGROUND
PMID: 32109013 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32091533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32167538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33334400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32171076 (View on PubMed)

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.

Reference Type 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.

Reference Type 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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Related Links

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https://drive.google.com/drive/u/0/folders/1BK1rSlpCR2KzydRxRp6KKUsqLezIKsAi

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

Other Identifiers

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COVIDPas1

Identifier Type: -

Identifier Source: org_study_id

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