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Completed

NCT Number: NCT04285801

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamela Youde Nethersole Eastern Hospital, Hong Kong

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 28 day mortality

    Time frame: 28 days

    survival or death at 28 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2020
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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