COVID19 Hospitilized in Clinica Pasteur of Neuquen (Argentina) (COVIDPas)

January 12, 2023 updated by: Gustavo Zabert, MD, Asociacion Latinoamericana de Torax

Cohort of COVID19 Patients Admitted to Pasteur Clinic 2020-2021

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Nqn
      • Neuquen, Nqn, Argentina, 8300
        • Pasteur clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 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
From date of admition until the date of death from any cause, assessed up to 28 day
Hospital mortality
Time Frame: From date of admition until the date of death from any cause, assessed up to 52 weeks
defined as death ocurred within hospitalization
From date of admition until the date of death from any cause, assessed up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Mechanical ventilation
Time Frame: 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
From date of admition until the date of equirement of invasive mechanical ventilation, assessed up to 21 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociacion Latinoamericana de Torax

Investigators

  • Principal Investigator: Gustavo Zabert, MD, Clínica Pasteur
  • Study Director: Ignacio Zabert, MD, Clínica Pasteur
  • Study Director: Ignacio Veltri, MD, Clínica Pasteur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

January 30, 2022

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVIDPas1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

at the end of the study or at specific requirements

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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