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

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ClinicalTrials.gov Identifier: NCT04285801
Recruitment Status : Completed
First Posted : February 26, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Lowell Ling, Chinese University of Hong Kong

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
COVID-19

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.

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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 : February 14, 2020
Actual Primary Completion Date : February 25, 2020
Actual Study Completion Date : February 25, 2020

Group/Cohort
COVID-19 infection
critically ill patients with COVID-19 infection



Primary Outcome Measures :
  1. 28 day mortality [ Time Frame: 28 days ]
    survival or death at 28 days


Secondary Outcome Measures :
  1. vasopressor days [ Time Frame: 28 days ]
    days on vasopressor

  2. days on mechanical ventilation [ Time Frame: 28 days ]
    days on mechanical ventilation during ICU stay

  3. sequential organ function assessment score [ Time Frame: daily for first 5 days ]
    daily sequential organ function assessment score (0 minimum to 24 maximum), higher scores worse organ function

  4. ECMO use [ Time Frame: 28 days ]
    Percentage of patients requiring ECMO during ICU stay.

  5. percentage nitric oxide use [ Time Frame: 28 days ]
    percentage of patients requiring nitric oxide during ICU stay.

  6. percentage free from oxygen supplement [ Time Frame: 28 days ]
    percentage not requiring oxygen therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All critically ill patients with confirmed COVID-19 infection in Hong Kong
Criteria

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


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): NCT04285801


Locations
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Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
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Responsible Party: Lowell Ling, Clinical Lecturer, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04285801    
Other Study ID Numbers: 2020.059
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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