Clinical trial NCT05087394: COVID19 Hospitilized in Clinica Pasteur of Neuquen (Argentina)
Official title: Cohort of COVID19 Patients Admitted to Pasteur Clinic 2020-2021
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Asociacion Latinoamericana de Torax
Sponsor class: INDUSTRY
First posted: 2021-10-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 28-day mortality
timeFrame: From date of admition until the date of death from any cause, assessed up to 28 day
measure: Hospital mortality
timeFrame: From date of admition until the date of death from any cause, assessed up to 52 weeks
Secondary outcomes:
measure: Invasive Mechanical ventilation
timeFrame: From date of admition until the date of equirement of invasive mechanical ventilation, assessed up to 21 day
Other outcomes:
Locations:
city: Neuquen
country: Argentina
facility: Pasteur Clinic
state: Nqn
Study officials:
affiliation: Clinica Pasteur
name: Gustavo Zabert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica Pasteur
name: Ignacio Zabert, MD
role: STUDY_DIRECTOR
affiliation: Clinica Pasteur
name: Ignacio Veltri, MD
role: STUDY_DIRECTOR
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citation: 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
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