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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
  • Hong Kong, Hong Kong
    • Princess Margaret Hospital
  • Hong Kong, Hong Kong
    • Pamela Youde Nethersole Eastern Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All critically ill patients with confirmed COVID-19 infection in Hong Kong

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28 day mortality	survival or death at 28 days	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vasopressor days	days on vasopressor	28 days
days on mechanical ventilation	days on mechanical ventilation during ICU stay	28 days
sequential organ function assessment score	daily sequential organ function assessment score (0 minimum to 24 maximum), higher scores worse organ function	daily for first 5 days
ECMO use	Percentage of patients requiring ECMO during ICU stay.	28 days
percentage nitric oxide use	percentage of patients requiring nitric oxide during ICU stay.	28 days
percentage free from oxygen supplement	percentage not requiring oxygen therapy	28 days

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): February 25, 2020
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 8, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020.059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No