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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 1756

Contacts and Locations

• Study Contact: Name: Judith Ju Ming Wong; Phone Number: +6592355980; Email: judith.wong.jm@singhealth.com.sg

Study Locations

• China
  • Chongqing, China
    • Chongqing Hospital Children's Medical Center
  • Zhengzhou, China
    • Zhengzhou Children'S Hospital
• India
  • Chandigarh, India
    • Post Graduate Institute of Medical Education and Research
• Indonesia
  • Medan, Indonesia
    • General Hospital H. Adam Malik
  • Medan, Indonesia
    • Murni Teguh Memorial Hospital
• Japan
  • Kanagawa, Japan
    • St. Marianna University School of Medicine
• Malaysia
  • Kluang, Malaysia
    • Hospital Enche' Besar Hajjah Khalsom
  • Kuala Lumpur, Malaysia
    • University Malaya Medical Centre
  • Pulau Pinang, Malaysia
    • Penang General Hospital
  • Seremban, Malaysia
    • Hospital Tuanku Ja'afar, Seremban, Malaysia
  • Kuala Lumpur
    • Bandar Tun Razak, Kuala Lumpur, Malaysia
      • Universiti Kebangsaan Malaysia Medical Centre
• Pakistan
  • Karachi, Pakistan
    • Aga Khan University Hospital
• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital
  • Singapore, Singapore
    • National University Hospital, Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control cases; Children who suspected COVID-19 cases but tested negative for COVID-19
Confirmed cases; Children who tested positive for COVID-19

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	60days (or duration of hospital stay)
Other systems complications	e.g. cardiovascular, renal, hepatic, neurological, haematological dysfunction	60days (or duration of hospital stay)
Mortality		60days (or duration of hospital stay)
Length of hospital stay		60days (or duration of hospital stay)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2020/2094

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No