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COVID-19COVIDPasNCT05087394

COVID19 Hospitilized in Clinica Pasteur of Neuquen (Argentina)

An observational study of COVID-19, run by Asociacion Latinoamericana de Torax at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Comorbidities
How many people
1,500 participants
Where
1 siteArgentina
Study dates
20 Mar 2020to 30 Jan 2022
How long will I take part?
2 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult patients with severe or critical (according to NIH) COVID19 diseased admitted to Pasteur Clinic in 202 and 2021

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Pasteur Clinic

    Neuquén, Nqn, 8300

Other trials in Argentina

About this study

Official title: 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

Read the 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.

Conditions
COVID-19
Being tested
Comorbidities
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ComorbiditiesOther

    Also called Oxigen requirement, Mechanical Ventilation, High flow nasal cannula, Chest CT scan

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day mortality

    defined as death ocurred within 28 days of admition to hospital

    Measured: From date of admition until the date of death from any cause, assessed up to 28 day

  2. Hospital mortality

    defined as death ocurred within hospitalization

    Measured: From date of admition until the date of death from any cause, assessed up to 52 weeks

Secondary outcomes (1)

  1. Invasive Mechanical ventilation

    defined as requirement of invasive mechanical ventilation support

    Measured: From date of admition until the date of equirement of invasive mechanical ventilation, assessed up to 21 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2021
  2. Study start20 Mar 2020
  3. Primary completion31 Dec 2021
  4. Study completion30 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,500 participants (actual)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05087394
Sponsor's protocol ID
COVIDPas1
Acronym
COVIDPas
Status last verified
Jan 2023
First submitted
18 Oct 2021
Last updated
13 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: at the end of the study or at specific requirements

Publications

  • 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.

    PubMed 32109013

  • 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.

    PubMed 32091533

  • 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.

    PubMed 32167538

  • 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.

    PubMed 33334400

  • 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.

    PubMed 32171076

  • 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.

  • 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.

  • 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

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

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Asociacion Latinoamericana de Torax at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-day mortality (time frame: From date of admition until the date of death from any cause, assessed up to 28 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05087394, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.

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