COVID-19NCT04285801
Critically Ill Patients With COVID-19 in Hong Kong: a Multicentre Observational Cohort Study
An observational study of COVID-19, run by Chinese University of Hong Kong at 3 sites in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 8 participants
- Where
- 3 sitesHong Kong
- Study dates
- 14 Feb 2020to 25 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All critically ill patients with confirmed COVID-19 infection in Hong Kong
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Prince of Wales Hospital
Hong Kong
Princess Margaret Hospital
Hong Kong
About this 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.
Read the 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.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 infection | critically ill patients with COVID-19 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day mortality
survival or death at 28 days
Measured: 28 days
Secondary outcomes (6)
vasopressor days
days on vasopressor
Measured: 28 days
days on mechanical ventilation
days on mechanical ventilation during ICU stay
Measured: 28 days
sequential organ function assessment score
daily sequential organ function assessment score (0 minimum to 24 maximum), higher scores worse organ function
Measured: daily for first 5 days
ECMO use
Percentage of patients requiring ECMO during ICU stay.
Measured: 28 days
percentage nitric oxide use
percentage of patients requiring nitric oxide during ICU stay.
Measured: 28 days
percentage free from oxygen supplement
percentage not requiring oxygen therapy
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start14 Feb 2020
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lowell Ling, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285801
- Sponsor's protocol ID
- 2020.059
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critically Ill Patients With COVID-19 in Hong Kong: a Multicentre Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04285801
- Acronym / sponsor ID
- 2020.059
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 infection | – | –critically ill patients with COVID-19 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All critically ill patients with confirmed COVID-19 infection in Hong Kong
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28 day mortality
Time frame: 28 days
survival or death at 28 days
6 secondary outcomes
vasopressor days
Time frame: 28 days
days on mechanical ventilation
Time frame: 28 days
sequential organ function assessment score
Time frame: daily for first 5 days
ECMO use
Time frame: 28 days
percentage nitric oxide use
Time frame: 28 days
percentage free from oxygen supplement
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Chinese University of Hong Kong at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.