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Analysis of Mortality of Critically Ill Patients With COVID-19

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: NCT04379258
Recruitment Status : Not yet recruiting
First Posted : May 7, 2020
Last Update Posted : May 13, 2020
Sponsor:
Collaborators:
Hospital Universitario del Tajo
Puerta de Hierro University Hospital
Hospital de Henares
Hospital Universitario Ramon y Cajal
Hospital Universitario de Móstoles
Hospital Universitario Severo Ochoa
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Hospital Universitario Madrid Sanchinarro
Hospital Universitario Santa Creu i Sant Pau
Hospital Universitario Infanta Cristina
Hospital General Universitario Gregorio Marañon
Hospital Universitario de Torrejón
Hospital Universitario La Paz
Hospital Universitario 12 de Octubre
Information provided by (Responsible Party):
Hospital Universitario Getafe

Brief Summary:
The recent pandemic of the COVID-19 disease has caused a national health emergency due to its severity and the clinical and social consequences of the disease. Crude mortality in Spain is 9.2%. However, the causes of death of critically ill patients with COVID-19 are unknown. To date, no treatment has been shown to be effective for the 2019-SARS-CoV-2 infection is recommended. Supportive care and isolation are recommended for infected individuals. Currently, observational studies on critically ill patients with COVID-19 have small samples. The objective is to evaluate the incidence of mortality and morbidity in COVID-19 disease in this group of critically ill patients, as well as the risk factors associated with mortality and the effectiveness of the treatments used compassionately.

Condition or disease
COVID-19 Critical Illness Effectiveness Outcome, Fatal

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Epidemiological Analysis of the Mortality of Critically Ill Patients With the COVID-19 Admitted to the Intensive Care Unit: An Observational, Prospective and Multicenter Study
Estimated Study Start Date : May 11, 2020
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020



Primary Outcome Measures :
  1. ICU mortality [ Time Frame: events during the ICU stay, up to 3 months ]
    rate (%)


Secondary Outcome Measures :
  1. hospital mortality [ Time Frame: events through study completion during the hospital stay, up to 5 months ]
    rate (%)

  2. 28-day mortality [ Time Frame: events through study completion considered from ICU admission up to 28 days ]
    rate (%)

  3. effectiveness of treatment [ Time Frame: through study completion considered from ICU admission until ICU discharge, up to 3 months ]
    rate (%). Incidence of outcome measures (ICU mortality), and appearance of complications (pneumonia or bacteriemia during ICU stay).

  4. length of ICU stay [ Time Frame: through study completion during ICU stay considered from ICU admission until ICU discharge as date of inclusion until the date of first documented discharge or date of death from any cause, whichever came first, assessed up to 3 months ]
    days

  5. length of hospital stay [ Time Frame: through study completion during ICU stay considered from ICU admission until ICU discharge as date of inclusion until the date of first documented hospital discharge or date of death from any cause, whichever came first, assessed up to 5 months ]
    days

  6. ventilator-associated pneumonia [ Time Frame: through duration of invasive ventilatory support period (from intubation date until date of successful extubation) through study completion up to 3 months ]
    rate (%)

  7. bacteriemia [ Time Frame: through study completion, up to 28-days ]
    rate (%)

  8. barotrauma [ Time Frame: through study completion, up to 28-days ]
    rate (%)

  9. duration of mechanical ventilation [ Time Frame: period of invasive controlled ventilatory support from date of orotraqueal intubation until date of successful extubation or assessed up to 3 months whichever came first ]
    days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Case definition : Any critically ill patients with a positive respiratory tract sample result (tracheal aspirate or nasopharyngeal exudate) using the PCR9 technique for the SARS-CoV-2 virus and requiring admission to the ICU at trial will be considered a confirmed case of COVID-19 disease of the doctor responsible for the sick.
Criteria

Inclusion Criteria:

  • patients over 18 years of age who are admitted to the ICU with the confirmed diagnosis of COVID-19.

Exclusion Criteria:

  • none

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): NCT04379258


Contacts
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Contact: Oscar Peñuelas, P.h.D +34916834982 openuelas@gmail.com
Contact: Laura Ojalvo +34916839360 ext 2731 proyectos@iisgetafe.com

Sponsors and Collaborators
Hospital Universitario Getafe
Hospital Universitario del Tajo
Puerta de Hierro University Hospital
Hospital de Henares
Hospital Universitario Ramon y Cajal
Hospital Universitario de Móstoles
Hospital Universitario Severo Ochoa
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Hospital Universitario Madrid Sanchinarro
Hospital Universitario Santa Creu i Sant Pau
Hospital Universitario Infanta Cristina
Hospital General Universitario Gregorio Marañon
Hospital Universitario de Torrejón
Hospital Universitario La Paz
Hospital Universitario 12 de Octubre
Investigators
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Principal Investigator: Oscar Peñuelas, P.h.D Fundación de Investigación del Hospital Universitario de Getafe
Publications of Results:
Other Publications:

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Responsible Party: Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT04379258    
Other Study ID Numbers: COVID-UCI_Spain
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: study protocol
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 3 months
Access Criteria: Direct request to the Principal Investigator

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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
Disease Attributes
Pathologic Processes