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One Year Follow-ups of Patients Admitted to Spanish Intensive Care Units Due to COVID-19

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ClinicalTrials.gov Identifier: NCT04457505
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
Barcelona Supercomputing Center
Carlos III Health Institute
Information provided by (Responsible Party):
Consorcio Centro de Investigación Biomédica en Red, M.P.

Brief Summary:

The latest epidemiological data published from Chine reports that up to 30% of hospital-admitted patients required admission to intensive care units (ICU). The cause for ICU admission for most patients is very severe respiratory failure; 80% of the patients present with severe acute respiratory distress syndrome (SARS) that requires protective mechanical ventilation.

Five percent of patients with SARS require extracorporeal circulation (ECMO) techniques. Global mortality data has been thus far reported in different individual publications from China. Without accounting for those patients still admitted to hospital, bona fide information (from a hospital in Wuhan) received by the PI of this project estimates that mortality of hospitalized patients is more than 10%. Evidently, mortality is concentrated in patients admitted to the ICU and those patients who require mechanical ventilation and present with SARS. As data in China was globally reported, risk factors and prognosis of patients with and without SARS who require mechanical ventilation are not definitively known. The efficacy of different treatments administered empirically or based on small, observation studies is also not known. With many still admitted at the time of publication, a recent study in JAMA about 1500 patients admitted to the ICU in the region of Lombardy (Italy) reported a crude mortality rate of 25%. The data published until the current date is merely observational, prospective or retrospective. Data has not been recorded by analysis performed with artificial intelligence (machine learning) in order to report much more personalized results. Furthermore, as it concerns patients admitted to the ICU who survive, respiratory and cardiovascular consequences, as well as quality of living are completely unknown.

The study further aims to investigate quality of life and different respiratory and cardiovascular outcomes at 6 months, as well as crude mortality within 1 year after discharge of patients with COVID-19 who survive following ICU admission. Lastly, with the objective to help personalize treatment in accordance with altered biological pathways in each patient, two types of studies will be performed: 1) epigenetics and 2) predictive enrichment of biomarkers in plasma.

Hypothesis

  • A significant percentage of patients (20%) admitted to the hospital with COVID-19 infection is expected to require ICU admission, and need mechanical ventilation (80%) and, in a minor percentage (5%), ECMO.
  • Patients who survive an acute episode during ICU hospitalization will have a yearly accumulated mortality of 40%. Those who then survive will have respiratory consequences, cardiovascular complications and poor quality of life (6 months).

Condition or disease
Acute Respiratory Distress Syndrome Severe Pneumonia Respiratory Failure

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Risk Factors, Personalized Prognoses and 1-year Follow-ups of Patients Admitted to Spanish Intensive Care Units Due to COVID-19
Actual Study Start Date : May 8, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021





Primary Outcome Measures :
  1. One year mortality [ Time Frame: At 12 months of ICU admission ]
    People who died after one year of follow up

  2. Six month mortality [ Time Frame: At 6 month of ICU admission ]
    People who died after one year of follow up


Biospecimen Retention:   Samples Without DNA

For the epigenetic study, blood samples will be gathered from 1000 patients within 48 hours after admission to the ICU. The collection and preparation of plasma samples will be done in accordance with Early Detection Research Network (EDRN) Standard Operating Procedures (National Cancer Institute, USA).

For the study of prognostic biomarkers, concentration of biomarkers in plasma that are key to potentially useful drugs' mechanism of action in this disease will be assessed. Plasma samples will be collected from 1000 patients within 48 hours after admission to the ICU.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to Spanish ICUs.
Criteria

Inclusion Criteria:

  • 1. Laboratory-confirmed COVID-19 infection with either real-time PCR or Next Generation Sequencing (NGS)
  • 2. Admission to intensive care unit

Exclusion Criteria:

  • 1. Patients admitted to COVID-19-negative ICU

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): NCT04457505


Contacts
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Contact: Adrian A Ceccato, PhD. +34932275400 ext 2015 aceccato@clinic.cat

Locations
Show Show 31 study locations
Sponsors and Collaborators
Consorcio Centro de Investigación Biomédica en Red, M.P.
Barcelona Supercomputing Center
Carlos III Health Institute
Investigators
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Principal Investigator: Antoni Torres, PhD Spanish Research Center for Respiratory Diseases
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Responsible Party: Consorcio Centro de Investigación Biomédica en Red, M.P.
ClinicalTrials.gov Identifier: NCT04457505    
Other Study ID Numbers: CIBERESUCICOVID
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD anonymized that underlie results in a publication will be available after publication.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After publication
Access Criteria: Data will be available after reasoning requested.

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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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Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury