Pediatric Acute and Critical Care COVID-19 Registry of Asia | NCT04395781

Studies
Pediatric Acute and Critical Care COVID-19 Registry of Asia

NCT04395781

Sponsor

KK Women's and Children's Hospital

Status

Completed

Last Update Posted

Mar 14, 2023Actual

Enrollment

1,756Actual

Phase

Not provided

Conditions

COVID
Pediatric Disorder

Interventions

Not provided

Countries

China
India
Indonesia
Japan
Malaysia
Pakistan
Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 18, 2020Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Mar 9, 2023Actual

First Submitted Date

May 18, 2020

First Submission Date that Met QC Criteria

May 19, 2020

First Posted Date

May 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2023

Last Update Posted Date

Mar 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

KK Women's and Children's HospitalOTHER_GOV

Collaborators

Name	Class
King Chulalongkorn Memorial Hospital	OTHER
Ramathibodi Hospital	OTHER
Post Graduate Institute of Medical Education and Research, Chandigarh	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In December 2019, an outbreak of pneumonia of unknown aetiology was first reported in the city of Wuhan, Hubei Province, People's Republic of China. Since then, a novel coronavirus, 2019 novel Coronavirus (2019-nCoV) has emerged as the most likely causative agent. To date, it has evolved into a pandemic involving over a million cases and thousands of deaths have been identified, including a high burden in countries like Italy, Spain, United Kingdom and the United States. This study aims to investigate the clinical epidemiology of 2019-novel coronavirus (2019-nCoV) pandemic in Asia.

Detailed Description

A retrospective/prospective outbreak study of all suspect cases admitted to hospital since the beginning of the pandemic (December 2019). Clinical and epidemiological information will be extracted from medical databases for analysis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

60 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,756Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control cases		Children who suspected COVID-19 cases but tested negative for COVID-19
Confirmed cases		Children who tested positive for COVID-19

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall severity of illness	Mild, moderate, severe, critical	60days (or duration of hospital stay)

Secondary Outcomes

Measure	Description	Time Frame
Respiratory complications	e.g. URTI, bronchiolitis, pneumonia, pneumothorax, effusion, pneumonitis, ARDS	60days (or duration of hospital stay)
Respiratory support	e.g. oxygen, HFNC, NIV, mechanical ventilation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COVID-19 suspected cases (by whatever definition)
COVID-19 confirmed cases (based on PCR or serum specific IgM and IgG antibody of novel coronavirus; serum specific IgG of novel coronavirus from negative to positive or 4 times higher in convalescence than in acute phase)
\

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

All children presenting to acute care hospitals within the PACCMAN collaborative sites.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Judith Ju Ming Wong	KK Women's and Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chongqing Hospital Children's Medical Center		Chongqing			China
Zhengzhou Children's hospital