Pediatric Acute and Critical Care COVID-19 Registry of Asia

COVID Clinical Trial

— PACCOVRA  

Official title:

Pediatric Acute and Critical Care COVID-19 Registry of Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04395781
• Other study ID #: 2020/2094
• Status: Completed
• Start date: May 18, 2020
• Est. completion date: March 9, 2023

Study information

• Verified date: March 2023
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1756
• Est. completion date: March 9, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Pediatric Disorder

Locations

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

Sponsors (17)

Lead Sponsor

Collaborator

KK Women's and Children's Hospital

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

Countries where clinical trial is conducted

China,  India,  Indonesia,  Japan,  Malaysia,  Pakistan,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall severity of illness	Mild, moderate, severe, critical	60days (or duration of hospital stay)
Secondary	Respiratory complications	e.g. URTI, bronchiolitis, pneumonia, pneumothorax, effusion, pneumonitis, ARDS	60days (or duration of hospital stay)
Secondary	Respiratory support	e.g. oxygen, HFNC, NIV, mechanical ventilation	60days (or duration of hospital stay)
Secondary	Other systems complications	e.g. cardiovascular, renal, hepatic, neurological, haematological dysfunction	60days (or duration of hospital stay)
Secondary	Mortality		60days (or duration of hospital stay)
Secondary	Length of hospital stay		60days (or duration of hospital stay)