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

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ClinicalTrials.gov Identifier: NCT04388670

Recruitment Status : Unknown

Verified May 2020 by Giacomo Grasselli, Policlinico Hospital.
Recruitment status was: Recruiting

First Posted : May 14, 2020

Last Update Posted : May 14, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Giacomo Grasselli, Policlinico Hospital

Study Description

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

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

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.

Criteria

Inclusion Criteria:

Adulthood
Informed consent obtained

Exclusion Criteria:

No informed consent obtained

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT04388670

Contacts

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Contact: Giacomo Grasselli, MD	+390255033285	giacomo.grasselli@unimi.it

Locations

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Italy
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico	Recruiting
Milan, Italy, 20100
Contact: Giacomo Grasselli, MD +390255033285 giacomo.grasselli@unimi.it

Sponsors and Collaborators

Policlinico Hospital

Investigators

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Principal Investigator:	Giacomo Grasselli, MD	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Scaravilli V, Guzzardella A, Madotto F, Beltrama V, Muscatello A, Bellani G, Monti G, Greco M, Pesenti A, Bandera A, Grasselli G. Impact of dexamethasone on the incidence of ventilator-associated pneumonia in mechanically ventilated COVID-19 patients: a propensity-matched cohort study. Crit Care. 2022 Jun 13;26(1):176. doi: 10.1186/s13054-022-04049-2.

Zanella A, Florio G, Antonelli M, Bellani G, Berselli A, Bove T, Cabrini L, Carlesso E, Castelli GP, Cecconi M, Citerio G, Coloretti I, Corti D, Dalla Corte F, De Robertis E, Foti G, Fumagalli R, Girardis M, Giudici R, Guiotto L, Langer T, Mirabella L, Pasero D, Protti A, Ranieri MV, Rona R, Scudeller L, Severgnini P, Spadaro S, Stocchetti N, Vigano M, Pesenti A, Grasselli G; COVID-19 Italian ICU Network. Time course of risk factors associated with mortality of 1260 critically ill patients with COVID-19 admitted to 24 Italian intensive care units. Intensive Care Med. 2021 Sep;47(9):995-1008. doi: 10.1007/s00134-021-06495-y. Epub 2021 Aug 9.

Grasselli G, Scaravilli V, Mangioni D, Scudeller L, Alagna L, Bartoletti M, Bellani G, Biagioni E, Bonfanti P, Bottino N, Coloretti I, Cutuli SL, De Pascale G, Ferlicca D, Fior G, Forastieri A, Franzetti M, Greco M, Guzzardella A, Linguadoca S, Meschiari M, Messina A, Monti G, Morelli P, Muscatello A, Redaelli S, Stefanini F, Tonetti T, Antonelli M, Cecconi M, Foti G, Fumagalli R, Girardis M, Ranieri M, Viale P, Raviglione M, Pesenti A, Gori A, Bandera A. Hospital-Acquired Infections in Critically Ill Patients With COVID-19. Chest. 2021 Aug;160(2):454-465. doi: 10.1016/j.chest.2021.04.002. Epub 2021 Apr 20.

Langer T, Brioni M, Guzzardella A, Carlesso E, Cabrini L, Castelli G, Dalla Corte F, De Robertis E, Favarato M, Forastieri A, Forlini C, Girardis M, Grieco DL, Mirabella L, Noseda V, Previtali P, Protti A, Rona R, Tardini F, Tonetti T, Zannoni F, Antonelli M, Foti G, Ranieri M, Pesenti A, Fumagalli R, Grasselli G; PRONA-COVID Group. Prone position in intubated, mechanically ventilated patients with COVID-19: a multi-centric study of more than 1000 patients. Crit Care. 2021 Apr 6;25(1):128. doi: 10.1186/s13054-021-03552-2.

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Responsible Party:	Giacomo Grasselli, Associate Professor, Policlinico Hospital
ClinicalTrials.gov 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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COVID-19 Critical Illness Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections	Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Disease Attributes Pathologic Processes

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