COVID19 Hospitilized in Clinica Pasteur of Neuquen (Argentina)

Completed

• Conditions: COVID-19

• Registration Number: NCT05087394
• Lead Sponsor: Asociacion Latinoamericana de Torax

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.

Study Timeline

• Study Start: 2020-03-20
• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-10-21
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day mortality	From date of admition until the date of death from any cause, assessed up to 28 day	defined as death ocurred within 28 days of admition to hospital
Hospital mortality	From date of admition until the date of death from any cause, assessed up to 52 weeks	defined as death ocurred within hospitalization

Secondary Outcome Measures

Name	Time	Method
Invasive Mechanical ventilation	From date of admition until the date of equirement of invasive mechanical ventilation, assessed up to 21 day	defined as requirement of invasive mechanical ventilation support

Trial Locations

Locations (1)

Pasteur Clinic; 🇦🇷 Neuquen, Nqn, Argentina