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

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

Tracking Information

• First Submitted Date: February 24, 2020
• First Posted Date: February 26, 2020
• Last Update Posted Date: March 10, 2020
• Actual Study Start Date: February 14, 2020
• Actual Primary Completion Date: February 25, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2020)

28 day mortality [ Time Frame: 28 days ]

survival or death at 28 days

Original Primary Outcome Measures (submitted: February 24, 2020)

2 week mortality [ Time Frame: 2 weeks ]

survival or death at 2 weeks

Current Secondary Outcome Measures (submitted: March 8, 2020)

• vasopressor days [ Time Frame: 28 days ]
  days on vasopressor
• days on mechanical ventilation [ Time Frame: 28 days ]
  days on mechanical ventilation during ICU stay
• 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
• ECMO use [ Time Frame: 28 days ]
  Percentage of patients requiring ECMO during ICU stay.
• percentage nitric oxide use [ Time Frame: 28 days ]
  percentage of patients requiring nitric oxide during ICU stay.
• percentage free from oxygen supplement [ Time Frame: 28 days ]
  percentage not requiring oxygen therapy

Original Secondary Outcome Measures (submitted: February 24, 2020)

• vasopressor use [ Time Frame: 2 weeks ]
  percentage of patients requiring vasopressor during ICU stay.
• mechanical ventilation [ Time Frame: 2 weeks ]
  Percentage of patients requiring mechanical ventilation during ICU stay.
• SOFA score [ Time Frame: daily for first 5 days ]
  daily SOFA score
• ECMO use [ Time Frame: 2 weeks ]
  Percentage of patients requiring ECMO during ICU stay.
• nitric oxide use [ Time Frame: 2 weeks ]
  percentage of patients requiring nitric oxide during ICU stay.
• free from oxygen supplement [ Time Frame: 2 weeks ]
  not requiring oxygen therapy

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Critically Ill Patients With COVID-19 in Hong Kong: a Multicentre Observational Cohort Study
• Official Title: Critically Ill Patients With COVID-19 in Hong Kong: a Multicentre Observational Cohort Study
• 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.

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
• Study Design: Observational Model: Case-Only; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All critically ill patients with confirmed COVID-19 infection in Hong Kong
• Condition: COVID-19
• Intervention: Not Provided

Study Groups/Cohorts

COVID-19 infection

critically ill patients with COVID-19 infection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 24, 2020): 8
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 25, 2020
• Actual Primary Completion Date: February 25, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT04285801
• Other Study ID Numbers: 2020.059
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Lowell Ling, Chinese University of Hong Kong
• Study Sponsor: Chinese University of Hong Kong
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Chinese University of Hong Kong
• Verification Date: March 2020