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Epidemiological and Clinical Characteristics of Critically Ill Patients With COVID-19 (2019nCoV_ICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04388670
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Information provided by (Responsible Party):
Giacomo Grasselli, Policlinico Hospital

Brief Summary:
Objective of this observational multicentric retrospective-prospective study is to describe the number and the characteristics of patients with Reverse Transcription Polymerase Chain Reaction (RT-PCR) for SARS-CoV2 positivity admitted to Intensive Care Units during the first 6 months of epidemic.

Condition or disease
COVID-19 Critical Illness

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Epidemiological and Clinical Characteristics of Patients With COVID-19 Admitted in Italian Intensive Care Units: a Multicentric Retrospective-prospective Cohort Study.
Actual Study Start Date : February 22, 2020
Estimated Primary Completion Date : August 22, 2020
Estimated Study Completion Date : August 31, 2020

Primary Outcome Measures :
  1. Overall number and characteristics of patients with COVID-19 in ICU [ Time Frame: 22nd February - 22nd August 2020 ]
    Number and characteristics of patients with COVID-19 admitted in Intensive Care Units every week.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with COVID-19 admitted in Intensive Care Units.

Inclusion Criteria:

  • Adulthood
  • Informed consent obtained

Exclusion Criteria:

  • No informed consent obtained

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04388670

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Contact: Giacomo Grasselli, MD +390255033285

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Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico Recruiting
Milan, Italy, 20100
Contact: Giacomo Grasselli, MD    +390255033285   
Sponsors and Collaborators
Policlinico Hospital
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Principal Investigator: Giacomo Grasselli, MD Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Giacomo Grasselli, Associate Professor, Policlinico Hospital Identifier: NCT04388670    
Other Study ID Numbers: PoliclinicoH
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes