Predictive Factors COVID-19 Patients

NCT ID: NCT04427345

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-30

Study Completion Date

2022-05-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Covid19 infection related patients

Patients admitted to COVID wards of the S. Gerardo Hospital of Monza, including Intensive Care wards.

Predictive factors for clinical response in patients with COVID-19.

Intervention Type OTHER

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 .

Interventions

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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 .

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Explicit refusal to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milano Bicocca

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ASST Monza-Ospedale San Gerardo

Monza, , Italy

Site Status

Countries

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Italy

References

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Rosenbaum L. Facing Covid-19 in Italy - Ethics, Logistics, and Therapeutics on the Epidemic's Front Line. N Engl J Med. 2020 May 14;382(20):1873-1875. doi: 10.1056/NEJMp2005492. Epub 2020 Mar 18. No abstract available.

Reference Type BACKGROUND
PMID: 32187459 (View on PubMed)

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

Reference Type BACKGROUND
PMID: 32007143 (View on PubMed)

Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

Reference Type BACKGROUND
PMID: 32031570 (View on PubMed)

Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.

Reference Type BACKGROUND
PMID: 32167524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32091533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32109013 (View on PubMed)

Other Identifiers

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MI-COVID

Identifier Type: -

Identifier Source: org_study_id

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