NCT04285801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

11 days

First QC Date

February 24, 2020

Last Update Submit

March 8, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • 28 day mortality

    survival or death at 28 days

    28 days

Secondary Outcomes (6)

  • vasopressor days

    28 days

  • days on mechanical ventilation

    28 days

  • sequential organ function assessment score

    daily for first 5 days

  • ECMO use

    28 days

  • percentage nitric oxide use

    28 days

  • +1 more secondary outcomes

Study Arms (1)

COVID-19 infection

critically ill patients with COVID-19 infection

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Princess Margaret Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 26, 2020

Study Start

February 14, 2020

Primary Completion

February 25, 2020

Study Completion

February 25, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(3)