PACCOVRA: Pediatric Acute and Critical Care COVID-19 Registry of Asia

Sponsor

KK Women's and Children's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04395781

Collaborator

King Chulalongkorn Memorial Hospital (Other), Ramathibodi Hospital (Other), Postgraduate Institute of Medical Education and Research, Chandigarh (Other), Rumah Sakit Anak dan Bunda Harapan Kita (Other), National University Hospital, Singapore (Other), St. Marianna University School of Medicine (Other), Tokyo Metropolitan Children's Medical Center, Japan (Other), Aichi Children's Health and Medical Center, Japan (Other), RS H Adam Malik (Other), Children's Hospital of Chongqing Medical University (Other), Zhengzhou Children's Hospital, China (Other), Universiti Kebangsaan Malaysia Medical Centre (Other), Penang Hospital, Malaysia (Other), Vicente Sotto Memorial Medical Center (Other), Hyogo Prefectural Kobe Children's Hospital (Other), Singapore Clinical Research Institute (Other)

2,000

Enrollment

Locations

43.4

Anticipated Duration (Months)

142.9

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID Pediatric Disorder

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Pediatric Acute and Critical Care COVID-19 Registry of Asia

Actual Study Start Date :

May 18, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Control cases Children who suspected COVID-19 cases but tested negative for COVID-19
Confirmed cases Children who tested positive for COVID-19

Outcome Measures

Primary Outcome Measures

Overall severity of illness [60days (or duration of hospital stay)]
Mild, moderate, severe, critical

Secondary Outcome Measures

Respiratory complications [60days (or duration of hospital stay)]
e.g. URTI, bronchiolitis, pneumonia, pneumothorax, effusion, pneumonitis, ARDS
Respiratory support [60days (or duration of hospital stay)]
e.g. oxygen, HFNC, NIV, mechanical ventilation
Other systems complications [60days (or duration of hospital stay)]
e.g. cardiovascular, renal, hepatic, neurological, haematological dysfunction
Mortality [60days (or duration of hospital stay)]
Length of hospital stay [60days (or duration of hospital stay)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)
</=21years of age

Exclusion Criteria:

COVID-19 suspected cases should not be SARSCoV-2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chongqing Hospital Children's Medical Center	Chongqing		China
2	Zhengzhou Children's hospital	Zhengzhou		China
3	Post Graduate Institute of Medical Education and Research	Chandigarh		India
4	General Hospital H. Adam Malik	Medan		Indonesia
5	Murni Teguh Memorial Hospital	Medan		Indonesia
6	St. Marianna University School of Medicine	Kanagawa		Japan
7	Universiti Kebangsaan Malaysia Medical Centre	Bandar Tun Razak	Kuala Lumpur	Malaysia
8	Hospital Enche' Besar Hajjah Khalsom	Kluang		Malaysia
9	University Malaya Medical Centre	Kuala Lumpur		Malaysia
10	Penang General Hospital	Pulau Pinang		Malaysia
11	Hospital Tuanku Ja'afar, Seremban, Malaysia	Seremban		Malaysia
12	Aga Khan University Hospital	Karachi		Pakistan
13	KK Women's and Children's Hospital	Singapore		Singapore	229899
14	National University Hospital, Singapore	Singapore		Singapore

Sponsors and Collaborators

KK Women's and Children's Hospital
King Chulalongkorn Memorial Hospital
Ramathibodi Hospital
Postgraduate Institute of Medical Education and Research, Chandigarh
Rumah Sakit Anak dan Bunda Harapan Kita
National University Hospital, Singapore
St. Marianna University School of Medicine
Tokyo Metropolitan Children's Medical Center, Japan
Aichi Children's Health and Medical Center, Japan
RS H Adam Malik
Children's Hospital of Chongqing Medical University
Zhengzhou Children's Hospital, China
Universiti Kebangsaan Malaysia Medical Centre
Penang Hospital, Malaysia
Vicente Sotto Memorial Medical Center
Hyogo Prefectural Kobe Children's Hospital
Singapore Clinical Research Institute

Investigators

Principal Investigator: Judith Ju Ming Wong, KK Women's and Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

KK Women's and Children's Hospital

ClinicalTrials.gov Identifier:

NCT04395781

Other Study ID Numbers:

2020/2094

First Posted:

May 20, 2020

Last Update Posted:

Sep 2, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 2, 2021