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Completed

NCT Number: NCT04395781

Pediatric Acute and Critical Care COVID-19 Registry of Asia

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.

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Key information

Conditions

COVID Pediatric Disorder

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chongqing Hospital Children's Medical Center, Chongqing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall severity of illness

    Time frame: 60days (or duration of hospital stay)

    Mild, moderate, severe, critical

Secondary outcomes

  1. Respiratory complications

    Time frame: 60days (or duration of hospital stay)

    e.g. URTI, bronchiolitis, pneumonia, pneumothorax, effusion, pneumonitis, ARDS

  2. Respiratory support

    Time frame: 60days (or duration of hospital stay)

    e.g. oxygen, HFNC, NIV, mechanical ventilation

  3. Other systems complications

    Time frame: 60days (or duration of hospital stay)

    e.g. cardiovascular, renal, hepatic, neurological, haematological dysfunction

  4. Mortality

    Time frame: 60days (or duration of hospital stay)

  5. Length of hospital stay

    Time frame: 60days (or duration of hospital stay)

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • 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
  • Post Graduate Institute of Medical Education and Research, Chandigarh
  • RS H Adam Malik
  • Ramathibodi Hospital
  • 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

Registry information

Acronym: PACCOVRA

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 20, 2020
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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