Critically Ill Patients With COVID-19 in Hong Kong: a Multicentre Observational Cohort Study

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT04285801
Collaborator
(none)
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Study Details

Study Description

Brief Summary

The purpose of this case series is to describe the characteristics, organ dysfunction and support and 2 week outcomes of critically ill patients with nCov infection.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China 1. It has manifest into a global health crisis with escalating confirmed cases and spread across 15 countries. Whilst it is currently an epidemic in China, The World Health Organization (WHO) Global Level risk assessment is set at high 2.

    Sequencing showed that 2019-nCov is similar to bat severe acute syndrome (SARS)-related coronaviruses found in Chinese horseshoe bats 3. This is compatible with the initial epidemiological link with a local wet market which sells bats. Furthermore, data sharing and sequencing data has facilitated development of accurate diagnostic tests.

    In contrast, our current understanding of the epidemiological and clinical features of 2019-nCov is limited. In a case series of 41 hospitalized patients with confirmed infection, at least 30% of these patients required critical care admission. These patients developed severe respiratory failure and 10% required mechanical ventilation and 5% needed extracorporeal membrane oxygenation support. More worryingly 2019-nCov infection was associated with 15% mortality. Although these figures are likely overestimates due to unreported mild cases, there is currently no effective treatment. The optimal supportive care for patients with severe 2019-nCov infection is a research priority.

    The spread of the 2019-nCov epidemic to Hong Kong has started. Patients have been admitted to the Intensive Care Unit for multiorgan dysfunction. Currently there are no published data focused specifically on critically ill patients with nCov infection. The purpose of this case series is to describe the characteristics, organ dysfunction and support and 2 week outcomes of critically ill patients with nCov infection.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    8 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Critically Ill Patients With COVID-19 in Hong Kong: a Multicentre Observational Cohort Study
    Actual Study Start Date :
    Feb 14, 2020
    Actual Primary Completion Date :
    Feb 25, 2020
    Actual Study Completion Date :
    Feb 25, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    COVID-19 infection

    critically ill patients with COVID-19 infection

    Outcome Measures

    Primary Outcome Measures

    1. 28 day mortality [28 days]

      survival or death at 28 days

    Secondary Outcome Measures

    1. vasopressor days [28 days]

      days on vasopressor

    2. days on mechanical ventilation [28 days]

      days on mechanical ventilation during ICU stay

    3. sequential organ function assessment score [daily for first 5 days]

      daily sequential organ function assessment score (0 minimum to 24 maximum), higher scores worse organ function

    4. ECMO use [28 days]

      Percentage of patients requiring ECMO during ICU stay.

    5. percentage nitric oxide use [28 days]

      percentage of patients requiring nitric oxide during ICU stay.

    6. percentage free from oxygen supplement [28 days]

      percentage not requiring oxygen therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • admission to ICU

    • adult (≥18 years old)

    • confirmed case of 2019-nCov infection by 2019-nCov RNA by reverse transcription polymerase chain reaction , isolation in cell culture of 2019-nCov from a clinical specimen or serum antibody to 2019-nCov

    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pamela Youde Nethersole Eastern Hospital Hong Kong Hong Kong
    2 Prince of Wales Hospital Hong Kong Hong Kong
    3 Princess Margaret Hospital Hong Kong Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lowell Ling, Clinical Lecturer, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT04285801
    Other Study ID Numbers:
    • 2020.059
    First Posted:
    Feb 26, 2020
    Last Update Posted:
    Mar 10, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 10, 2020