NCT04395781

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,756

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
7 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

May 18, 2020

Last Update Submit

March 12, 2023

Conditions

COVIDPediatric Disorder

Outcome Measures

Primary Outcomes (1)

  • Overall severity of illness

    Mild, moderate, severe, critical

    60days (or duration of hospital stay)

Secondary Outcomes (5)

  • Respiratory complications

    60days (or duration of hospital stay)

  • Respiratory support

    60days (or duration of hospital stay)

  • Other systems complications

    60days (or duration of hospital stay)

  • Mortality

    60days (or duration of hospital stay)

  • Length of hospital stay

    60days (or duration of hospital stay)

Study Arms (2)

Control cases

Children who suspected COVID-19 cases but tested negative for COVID-19

Confirmed cases

Children who tested positive for COVID-19

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Chongqing Hospital Children's Medical Center

Chongqing, China

Location

Zhengzhou Children's hospital

Zhengzhou, China

Location

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Location

General Hospital H. Adam Malik

Medan, Indonesia

Location

Murni Teguh Memorial Hospital

Medan, Indonesia

Location

St. Marianna University School of Medicine

Kanagawa, Japan

Location

Universiti Kebangsaan Malaysia Medical Centre

Bandar Tun Razak, Kuala Lumpur, Malaysia

Location

Hospital Enche' Besar Hajjah Khalsom

Kluang, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Penang General Hospital

Pulau Pinang, Malaysia

Location

Hospital Tuanku Ja'afar, Seremban, Malaysia

Seremban, Malaysia

Location

Aga Khan University Hospital

Karachi, Pakistan

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

National University Hospital, Singapore

Singapore, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Respiratory fluid Stool

Study Officials

  • Judith Ju Ming Wong

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
60 Days
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 20, 2020

Study Start

May 18, 2020

Primary Completion

December 31, 2022

Study Completion

March 9, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations

SG(2)JP(1)ID(2)MY(5)PA(1)CN(2)IN(1)