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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.
 
ClinicalTrials.gov Identifier: NCT04388670
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Giacomo Grasselli, Policlinico Hospital

Tracking Information
First Submitted Date May 12, 2020
First Posted Date May 14, 2020
Last Update Posted Date May 14, 2020
Actual Study Start Date February 22, 2020
Estimated Primary Completion Date August 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 12, 2020)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiological and Clinical Characteristics of Critically Ill Patients With COVID-19
Official Title Epidemiological and Clinical Characteristics of Patients With COVID-19 Admitted in Italian Intensive Care Units: a Multicentric Retrospective-prospective Cohort Study.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with COVID-19 admitted in Intensive Care Units.
Condition
  • COVID-19
  • Critical Illness
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 12, 2020)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2020
Estimated Primary Completion Date August 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adulthood
  • Informed consent obtained

Exclusion Criteria:

  • No informed consent obtained
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Giacomo Grasselli, MD +390255033285 giacomo.grasselli@unimi.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04388670
Other Study ID Numbers PoliclinicoH
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Giacomo Grasselli, Policlinico Hospital
Study Sponsor Policlinico Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Giacomo Grasselli, MD Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
PRS Account Policlinico Hospital
Verification Date May 2020