COVID19 Hospitilized in Clinica Pasteur of Neuquen (Argentina)

COVID-19 Clinical Trial

— COVIDPas  

Official title:

Cohort of COVID19 Patients Admitted to Pasteur Clinic 2020-2021

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05087394
• Other study ID #: COVIDPas1
• Status: Completed
• Start date: March 20, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: January 2023
• Source: Asociacion Latinoamericana de Torax
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: January 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Argentina	Pasteur Clinic	Neuquen	Nqn

Sponsors (1)

Lead Sponsor	Collaborator
Asociacion Latinoamericana de Torax

Country where clinical trial is conducted

Argentina, 

References & Publications (9)

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.

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

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. — View Citation

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. — View Citation

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.

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

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. — View Citation

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. — View Citation

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. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Invasive Mechanical ventilation	defined as requirement of invasive mechanical ventilation support	From date of admition until the date of equirement of invasive mechanical ventilation, assessed up to 21 day

External 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