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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285801
• Other study ID #: 2020.059
• Status: Completed
• Start date: February 14, 2020
• Est. completion date: February 25, 2020

Study information

• Verified date: March 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Critical Illness

Locations

Country	Name	City	State
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Princess Margaret Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 day mortality	survival or death at 28 days	28 days
Secondary	vasopressor days	days on vasopressor	28 days
Secondary	days on mechanical ventilation	days on mechanical ventilation during ICU stay	28 days
Secondary	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
Secondary	ECMO use	Percentage of patients requiring ECMO during ICU stay.	28 days
Secondary	percentage nitric oxide use	percentage of patients requiring nitric oxide during ICU stay.	28 days
Secondary	percentage free from oxygen supplement	percentage not requiring oxygen therapy	28 days