Pediatric Acute and Critical Care COVID-19 Registry of Asia

Completed

• Conditions: COVID; Pediatric Disorder

• Registration Number: NCT04395781
• Lead Sponsor: KK Women's and Children's Hospital

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.

Study Timeline

• Study Start: 2020-05-18
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-20
• Primary Completion: 2022-12-31
• Status Verified: 2023-03
• Study Completion: 2023-03-09
• Last Update Submitted: 2023-03-12
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1756

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall severity of illness	60days (or duration of hospital stay)	Mild, moderate, severe, critical

Secondary Outcome Measures

Name	Time	Method
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
Length of hospital stay	60days (or duration of hospital stay)
Respiratory complications	60days (or duration of hospital stay)	e.g. URTI, bronchiolitis, pneumonia, pneumothorax, effusion, pneumonitis, ARDS
Mortality	60days (or duration of hospital stay)

Trial Locations

Locations (14)

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore

National University Hospital, Singapore; 🇸🇬 Singapore, Singapore

Universiti Kebangsaan Malaysia Medical Centre; 🇲🇾 Bandar Tun Razak, Kuala Lumpur, Malaysia

Hospital Tuanku Ja'afar, Seremban, Malaysia; 🇲🇾 Seremban, Malaysia

Zhengzhou Children's hospital; 🇨🇳 Zhengzhou, China

Murni Teguh Memorial Hospital; 🇮🇩 Medan, Indonesia

St. Marianna University School of Medicine; 🇯🇵 Kanagawa, Japan

Hospital Enche' Besar Hajjah Khalsom; 🇲🇾 Kluang, Malaysia

Chongqing Hospital Children's Medical Center; 🇨🇳 Chongqing, China

General Hospital H. Adam Malik; 🇮🇩 Medan, Indonesia

Penang General Hospital; 🇲🇾 Pulau Pinang, Malaysia

Aga Khan University Hospital; 🇵🇰 Karachi, Pakistan