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Predictive Factors COVID-19 Patients (MI-COVID)

19. maj 2022 opdateret af: University of Milano Bicocca

Predictive Clinical Response Factors in COVID-19 Patients

This is a monocentric retro-prospective observational study that will be conducted on all COVID19 positive patients hospitalized at the S. Gerardo Hospital in Monza.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

BACKGROUND:

The Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic is severely testing the health systems of the most advanced countries. Clinicians are faced with a new pathology of an emerging virus. There is therefore an urgent need to collect real-time clinical data that informs about outcome predictive variables. Furthermore, there are currently no antiviral drugs approved for the treatment of SARS-CoV-2 infection, off-label therapies are being used with drugs already in use for other pathologies that have shown some efficacy in vitro, and some treatments obtained for compassionate use with other drugs that are being tested.

It is more than ever necessary to collect clinical practice data both retrospectively on the work done so far, and in a longitudinal perspective, and analyze them quickly to optimize current treatments and define protocols for the future. Having a good clinical data base also offers the possibility of collaborating with numerous international networks on translational research, which aims to correlate clinical data with virological and immunological data, aimed at the rapid identification of possible specific viral virulence factors, or particular immune structures of the guests who once again define the final clinical outcome.

STUDY DESIGN:

All COVID19 positive patients admitted to San Gerardo Hospital will be enrolled in the study.

After patient signs the informed consent, the following data will be collected:

  • birth data
  • sex
  • demographic data
  • comorbidity
  • blood chemistry data at the entrance

A series of variables will then be collected relating to the treatment procedure, the therapies, the team's choice to maximize the care ceiling in the individual patient and the entire clinical study of the patient.

STATISTICAL ANALISYS:

Central tendency and dispersion measurements will be used for descriptive analysis of continuous variables while absolute and relative frequencies will be used to describe categorical variables.

Undersøgelsestype

Observationel

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
      • Monza, Italien
        • ASST Monza-Ospedale San Gerardo

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study involves patients admitted to San Gerardo Hospital from March 1, 2020 to May 31, 2020. The minimum expected follow-up will be one year for all patients.

Given the nature of the study, no formal calculation of the sample size was made, nor was a sample size predefined. However, given the recruiting potential of the center which in March saw on average 30-60 hospitalizations due to SARS-CoV-2 per day, even considering a progressive decrease in access, it is assumed that the proportion of patients who will be included in the study will exceed 1000 units.

Beskrivelse

Inclusion Criteria:

  • Patients 18 years old or above
  • Diagnosis of SARS-CoV-2 pneumonia

Exclusion Criteria:

  • Explicit refusal to participate in the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Covid19 infection related patients
Patients admitted to COVID wards of the S. Gerardo Hospital of Monza, including Intensive Care wards.
Andet: Predictive factors for clinical response in patients with COVID-19.
Identify the risk factors for intra-hospital mortality in patients hospitalized in the COVID + hospital wards of the San Gerardo hospital and build a prognostic score through which it is possible to define a stratification that immediately guides the therapeutic choices and the intensity of care .

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Identify risk factors for intra-hospital mortality.
Tidsramme: Until patient discharge from the hospital (approximately 1 year)
Identify risk factors for intra-hospital mortality in patients admitted to the COVID + hospital wards of San Gerardo hospital.
Until patient discharge from the hospital (approximately 1 year)
Identify risk factors to build a prognostic score.
Tidsramme: Until patient discharge from the hospital (approximately 1 year)
Identify the risk factors to build a prognostic score through which it is possible to define a stratification that immediately guides the therapeutic choices.
Until patient discharge from the hospital (approximately 1 year)
Identify risk factors to build a prognostic score.
Tidsramme: Until patient discharge from the hospital (approximately 1 year)
Identify the risk factors to build a prognostic score through which it is possible to define a stratification that immediately directs towards the right intensity of care.
Until patient discharge from the hospital (approximately 1 year)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Predictive factors for the hospitalization duration.
Tidsramme: Until patient discharge from the hospital (approximately 1 year)
Description of the predictive factors for the hospitalization duration.
Until patient discharge from the hospital (approximately 1 year)
Predictive factors for clinical status patients based on "Ordinal Scale for Clinical Improvement"
Tidsramme: Until patient discharge from the hospital (approximately 1 year)
Description of the predictive factors for the clinical status of patients based on "Ordinal Scale for Clinical Improvement" defined by OMS (
Until patient discharge from the hospital (approximately 1 year)
Describe the anti-viral therapies used commonly in this emergency in terms of efficacy
Tidsramme: Until patient discharge from the hospital (approximately 1 year).
Description of efficacy of the anti-viral therapies used today without particular restrictions, but on which solid clinical functioning tests are lacking.
Until patient discharge from the hospital (approximately 1 year).
Describe the anti-viral therapies used commonly used in this emergency in terms of safety
Tidsramme: Until patient discharge from the hospital (approximately 1 year).
Description of safety of the anti-viral therapies used today without particular restrictions, but on which solid clinical functioning tests are lacking.
Until patient discharge from the hospital (approximately 1 year).
Monitor the clinical course of the disease in discharged patients.
Tidsramme: 12 month after discharge
Description of the disease clinical course in patients 12 months after discharge (mortality, neurological, respiratory and cardiac outcomes).
12 month after discharge

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Milano Bicocca

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. april 2020

Primær færdiggørelse (Forventet)

1. maj 2021

Studieafslutning (Faktiske)

12. maj 2022

Datoer for studieregistrering

Først indsendt

4. juni 2020

Først indsendt, der opfyldte QC-kriterier

10. juni 2020

Først opslået (Faktiske)

11. juni 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MI-COVID

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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Kliniske forsøg med covid19

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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