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

March 12, 2023 updated by: KK Women's and Children's Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1756

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall severity of illness
Time Frame: 60days (or duration of hospital stay)
Mild, moderate, severe, critical
60days (or duration of hospital stay)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Respiratory complications
Time Frame: 60days (or duration of hospital stay)
e.g. URTI, bronchiolitis, pneumonia, pneumothorax, effusion, pneumonitis, ARDS
60days (or duration of hospital stay)
Respiratory support
Time Frame: 60days (or duration of hospital stay)
e.g. oxygen, HFNC, NIV, mechanical ventilation
60days (or duration of hospital stay)
Other systems complications
Time Frame: 60days (or duration of hospital stay)
e.g. cardiovascular, renal, hepatic, neurological, haematological dysfunction
60days (or duration of hospital stay)
Mortality
Time Frame: 60days (or duration of hospital stay)
60days (or duration of hospital stay)
Length of hospital stay
Time Frame: 60days (or duration of hospital stay)
60days (or duration of hospital stay)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KK Women's and Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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