COVIDPACCOVRANCT04395781
Pediatric Acute and Critical Care COVID-19 Registry of Asia
An observational study of COVID and Pediatric Disorder, run by KK Women's and Children's Hospital at 14 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- COVID, Pediatric Disorder
- How many people
- 1,756 participants
- Where
- 14 sitesin 7 countries
- Study dates
- 18 May 2020to 9 Mar 2023
- How long will I take part?
- 60 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children presenting to acute care hospitals within the PACCMAN collaborative sites.
Who may be able to join
- 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
Who cannot join
- COVID-19 suspected cases should not be SARSCoV-2
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
Malaysia5 sites
Universiti Kebangsaan Malaysia Medical Centre
Bandar Tun Razak, Kuala Lumpur
Hospital Enche' Besar Hajjah Khalsom
Kluang
University Malaya Medical Centre
Kuala Lumpur
Penang General Hospital
Pulau Pinang
Hospital Tuanku Ja'afar, Seremban, Malaysia
Seremban
China2 sites
Chongqing Hospital Children's Medical Center
Chongqing
Zhengzhou Children's hospital
Zhengzhou
Indonesia2 sites
General Hospital H. Adam Malik
Medan
Murni Teguh Memorial Hospital
Medan
Singapore2 sites
KK Women's and Children's Hospital
Singapore, 229899
National University Hospital, Singapore
Singapore
India1 site
Post Graduate Institute of Medical Education and Research
Chandigarh
About this study
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.
Read the 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.
- Conditions
- COVID, Pediatric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Overall severity of illness
Mild, moderate, severe, critical
Measured: 60days (or duration of hospital stay)
Secondary outcomes (5)
Respiratory complications
e.g. URTI, bronchiolitis, pneumonia, pneumothorax, effusion, pneumonitis, ARDS
Measured: 60days (or duration of hospital stay)
Respiratory support
e.g. oxygen, HFNC, NIV, mechanical ventilation
Measured: 60days (or duration of hospital stay)
Other systems complications
e.g. cardiovascular, renal, hepatic, neurological, haematological dysfunction
Measured: 60days (or duration of hospital stay)
Mortality
Measured: 60days (or duration of hospital stay)
Length of hospital stay
Measured: 60days (or duration of hospital stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start18 May 2020
- Primary completion31 Dec 2022
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,756 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- King Chulalongkorn Memorial Hospital, Ramathibodi Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh, Rumah Sakit Anak dan Bunda Harapan Kita, National University Hospital, Singapore, St. Marianna University School of Medicine, Tokyo Metropolitan Children's Medical Center, Japan, Aichi Children's Health and Medical Center, Japan, RS H Adam Malik, Children's Hospital of Chongqing Medical University, Zhengzhou Children's Hospital, China, Universiti Kebangsaan Malaysia Medical Centre, Penang Hospital, Malaysia, Vicente Sotto Memorial Medical Center, Hyogo Prefectural Kobe Children's Hospital, Singapore Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Judith Ju Ming Wong, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395781
- Sponsor's protocol ID
- 2020/2094
- Acronym
- PACCOVRA
- Status last verified
- Mar 2023
- First submitted
- 18 May 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Acute and Critical Care COVID-19 Registry of Asia
- ClinicalTrials.gov ID
- NCT04395781
- Acronym / sponsor ID
- PACCOVRA / 2020/2094
- Conditions
- COVID, Pediatric Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,756 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- King Chulalongkorn Memorial Hospital, Ramathibodi Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh, Rumah Sakit Anak dan Bunda Harapan Kita, National University Hospital, Singapore, St. Marianna University School of Medicine, Tokyo Metropolitan Children's Medical Center, Japan, Aichi Children's Health and Medical Center, Japan, RS H Adam Malik, Children's Hospital of Chongqing Medical University, Zhengzhou Children's Hospital, China, Universiti Kebangsaan Malaysia Medical Centre, Penang Hospital, Malaysia, Vicente Sotto Memorial Medical Center, Hyogo Prefectural Kobe Children's Hospital, Singapore Clinical Research Institute
- Study start
- 18 May 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 60 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control cases | – | –Children who suspected COVID-19 cases but tested negative for COVID-19 |
| Confirmed cases | – | –Children who tested positive for COVID-19 |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children presenting to acute care hospitals within the PACCMAN collaborative sites.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- COVID-19 suspected cases should not be SARSCoV-2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall severity of illness
Time frame: 60days (or duration of hospital stay)
Mild, moderate, severe, critical
5 secondary outcomes
Respiratory complications
Time frame: 60days (or duration of hospital stay)
Respiratory support
Time frame: 60days (or duration of hospital stay)
Other systems complications
Time frame: 60days (or duration of hospital stay)
Mortality
Time frame: 60days (or duration of hospital stay)
Length of hospital stay
Time frame: 60days (or duration of hospital stay)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Ju Ming Wong principal investigator
KK Women's and Children's Hospital
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Pediatric Disorder, run by KK Women's and Children's Hospital at 14 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Malaysia, China, Indonesia, Singapore, India and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall severity of illness (time frame: 60days (or duration of hospital stay)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.