Clinical trial NCT04395781: Pediatric Acute and Critical Care COVID-19 Registry of Asia
Official title: Pediatric Acute and Critical Care COVID-19 Registry of Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Pediatric Disorder
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: King Chulalongkorn Memorial Hospital
name: Ramathibodi Hospital
name: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Rumah Sakit Anak dan Bunda Harapan Kita
name: National University Hospital, Singapore
name: St. Marianna University School of Medicine
name: Tokyo Metropolitan Children's Medical Center, Japan
name: Aichi Children's Health and Medical Center, Japan
name: RS H Adam Malik
name: Children's Hospital of Chongqing Medical University
name: Zhengzhou Children's Hospital, China
name: Universiti Kebangsaan Malaysia Medical Centre
name: Penang Hospital, Malaysia
name: Vicente Sotto Memorial Medical Center
name: Hyogo Prefectural Kobe Children's Hospital
name: Singapore Clinical Research Institute
First posted: 2020-05-20
Enrollment: 1756
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children presenting to acute care hospitals within the PACCMAN collaborative sites.

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.

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)
* \</=21years of age

Exclusion Criteria:

* COVID-19 suspected cases should not be SARSCoV-2

Primary outcomes:
measure: Overall severity of illness
timeFrame: 60days (or duration of hospital stay)
Secondary outcomes:
measure: Respiratory complications
timeFrame: 60days (or duration of hospital stay)
measure: Respiratory support
timeFrame: 60days (or duration of hospital stay)
measure: Other systems complications
timeFrame: 60days (or duration of hospital stay)
measure: Mortality
timeFrame: 60days (or duration of hospital stay)
measure: Length of hospital stay
timeFrame: 60days (or duration of hospital stay)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Hospital Children's Medical Center
city: Zhengzhou
country: China
facility: Zhengzhou Children's hospital
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
city: Medan
country: Indonesia
facility: General Hospital H. Adam Malik
city: Medan
country: Indonesia
facility: Murni Teguh Memorial Hospital
city: Kanagawa
country: Japan
facility: St. Marianna University School of Medicine
city: Bandar Tun Razak
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Centre
state: Kuala Lumpur
city: Kluang
country: Malaysia
facility: Hospital Enche' Besar Hajjah Khalsom
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Pulau Pinang
country: Malaysia
facility: Penang General Hospital
city: Seremban
country: Malaysia
facility: Hospital Tuanku Ja'afar, Seremban, Malaysia
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
Study officials:
affiliation: KK Women's and Children's Hospital
name: Judith Ju Ming Wong
role: PRINCIPAL_INVESTIGATOR
References: