Covid19MOIS-CoRNCT04811456
MultiOrgan Inflammatory Syndromes COVID-19 Related Study
An observational study of Covid19, run by Medical University of Warsaw at 2 sites in Poland.
Trial summary
The study comprise a nationwide, voluntary, on-line survey of inflammatory syndromes in children for retrospective (since 4th March 2020) and prospective data collection. Our aim was to capture and describe multisystem inflammatory syndrome in children (MIS-C) in Poland. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Covid19
- What is being tested?
- multisystem inflammatory syndrome in children (MIS-C)
- How many people
- 1,000 participants
- Where
- 2 sitesPoland
- Study dates
- 25 May 2020to 25 Aug 2025
- How long will I take part?
- 5 Years
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 0-18 years old hospitalized with inflammatory conditions
Who may be able to join
- patients who required hospitalization since 4th March 2020;
- diagnosed Kawasaki disease (KD) or incomplete (atypical) Kawasaki disease (aKD) or toxic shock syndrome (TSS) or macrophage activation syndrome (MAS) or unspecified inflammatory syndrome;
Who cannot join
- other infectious and non-infectious causes that could be responsible for the disease
- SARS-CoV-2 polymerase chain reaction (PCR) or serology result could have been positive or negative. Due to limited availability and reliability of serologic testing, proven or likely COVID-19 criterion was not a condition determining inclusion to the registry.
Trial locations and contacts
2 sites in 1 country.
Natalia Dudek, MD contact
Poland2 sites, 2 recruiting
- Recruiting
Medical University of Warsaw Children's Hospital
Warsaw, 02091
Magdalena Okarska-Napierala, MD, +48 503 065 849, mnapierala@wum.edu.pl
- Recruiting
Wroclaw Medical University
Wroclaw, 50-368
Kamila Ludwikowska, kama.ludwikowska@gmail.com
About this study
The study comprise a nationwide, voluntary, on-line survey of inflammatory syndromes in children for retrospective (since 4th March 2020) and prospective data collection. Our aim was to capture and describe multisystem inflammatory syndrome in children (MIS-C) in Poland.
Read the detailed description
The voluntary surveillance for retrospective (since 4th March) and prospective data collection was initiated under the National Consultant of Pediatrics auspices. Anonymized patient data from pediatric hospitals from all over the country are extracted from electronic and paper records and collected through online form developed for that purpose. Before the surveillance was launched, reporting clinicians underwent an online training, which included the current state of knowledge about multisystem inflammatory syndrome in children (MIS-C). Patient management is at the discretion of the relevant treating clinicians.
KD and aKD were defined following the American Heart Association (AHA) guidelines.
TSS was established based on modified criteria by the Centers for Disease Control and Prevention.
MAS was diagnosed based on the Paediatric Rheumatology International Trials Organization (PRINTO) criteria for MAS classification.
The definition of the inflammatory syndrome was based on the WHO MIS-C definition with the exclusion of SARS-CoV-2 confirmation.
For patients who met the inclusion criteria, demographic data, past medical history, data on COVID-19 exposure, clinical symptoms, physical examination findings, laboratory, imaging, and cardiologic tests results, treatment, and outcome data are collected.
All study definitions are defined in accordance to relevant guidelines and evaluated automatically with the use of a dedicated software.
- Conditions
- Covid19
- Being tested
- multisystem inflammatory syndrome in children (MIS-C)
- Keywords
- MIS-C, PIMS-TS, COVID-19, hyperinflammation, children
- Medical subject headings
- COVID-19, pediatric multisystem inflammatory disease, COVID-19 related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multisystem inflammatory syndrome in children (MIS-C)Other
as in group description
| Study group | Role | What they receive |
|---|---|---|
| MIS-C | Cases fulfilling following criteria:
1. fever ≥3 days
2. at least two of the following:
* rash or bilateral conjunctivitis or mucocutaneous inflammation signs
* hypotension
* features of myocardial dysfunction, pericarditis, or coronary artery abnormality, based on echocardiographic findings or elevated B-type natriuretic peptide (BNP)/N-terminal-pro-BNP (NT-proBNP) or troponin
* evidence of coagulopathy
* acute gastrointestinal problems
3. elevated inflammatory markers AND
4. no other apparent microbial cause
5. evidence of COVID-19 (positive real-time polymerase chain reaction, antigen test or serology), or personal history of COVID-19 or contact with a proven COVID-19 case Receives: Other: multisystem inflammatory syndrome in children (MIS-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PICU
pediatric intensive care unit treatment need
Measured: 5 years
Secondary outcomes (3)
Heart dysfunction
Heart dysfunction is defined as ejection fraction (EF) of <55% and severe heart dysfunction as EF <35%.
Measured: 5 years
CAA
Coronary artery abnormalities comprise both coronary dilation and/or coronary aneurysm. Dilation was defined by Z-score between 2 to 2.5, while aneurysm by Z score ≥2.5
Measured: 5 years
Hypotension
Hypotension is defined by a minimal systolic blood pressure (sBP) below 70+2×age (in years) mmHg or below 90 mmHg for children >10 years old
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start25 May 2020
- Primary completion25 May 2025 (estimated)
- Study completion25 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University, University of Warsaw
- Responsible party
- Sponsor
- Investigators
- Magdalena Okarska-Napierała, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811456
- Sponsor's protocol ID
- MOIS-CoR
- Acronym
- MOIS-CoR
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MultiOrgan Inflammatory Syndromes COVID-19 Related Study
- ClinicalTrials.gov ID
- NCT04811456
- Acronym / sponsor ID
- MOIS-CoR / MOIS-CoR
- Conditions
- Covid19
- Keywords
- MIS-C, PIMS-TS, COVID-19, hyperinflammation, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Wroclaw Medical University, University of Warsaw
- Study start
- 25 May 2020 (actual)
- Primary completion
- 25 May 2025 (estimated)
- Study completion
- 25 Aug 2025 (estimated)
- First posted
- 23 Mar 2021 (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.
The study comprise a nationwide, voluntary, on-line survey of inflammatory syndromes in children for retrospective (since 4th March 2020) and prospective data collection. Our aim was to capture and describe multisystem inflammatory syndrome in children (MIS-C) in Poland.
Detailed description
The voluntary surveillance for retrospective (since 4th March) and prospective data collection was initiated under the National Consultant of Pediatrics auspices. Anonymized patient data from pediatric hospitals from all over the country are extracted from electronic and paper records and collected through online form developed for that purpose. Before the surveillance was launched, reporting clinicians underwent an online training, which included the current state of knowledge about multisystem inflammatory syndrome in children (MIS-C). Patient management is at the discretion of the relevant treating clinicians.
KD and aKD were defined following the American Heart Association (AHA) guidelines.
TSS was established based on modified criteria by the Centers for Disease Control and Prevention.
MAS was diagnosed based on the Paediatric Rheumatology International Trials Organization (PRINTO) criteria for MAS classification.
The definition of the inflammatory syndrome was based on the WHO MIS-C definition with the exclusion of SARS-CoV-2 confirmation.
For patients who met the inclusion criteria, demographic data, past medical history, data on COVID-19 exposure, clinical symptoms, physical examination findings, laboratory, imaging, and cardiologic tests results, treatment, and outcome data are collected.
All study definitions are defined in accordance to relevant guidelines and evaluated automatically with the use of a dedicated software.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIS-C | – | Other: multisystem inflammatory syndrome in children (MIS-C)Cases fulfilling following criteria: 1. fever ≥3 days 2. at least two of the following: * rash or bilateral conjunctivitis or mucocutaneous inflammation signs * hypotension * features of myocardial dysfunction, pericarditis, or coronary artery abnormality, based on echocardiographic findings or elevated B-type natriuretic peptide (BNP)/N-terminal-pro-BNP (NT-proBNP) or troponin * evidence of coagulopathy * acute gastrointestinal problems 3. elevated inflammatory markers AND 4. no other apparent microbial cause 5. evidence of COVID-19 (positive real-time polymerase chain reaction, antigen test or serology), or personal history of COVID-19 or contact with a proven COVID-19 case |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 0-18 years old hospitalized with inflammatory conditions
Key inclusion criteria (2 listed)
- patients who required hospitalization since 4th March 2020;
- diagnosed Kawasaki disease (KD) or incomplete (atypical) Kawasaki disease (aKD) or toxic shock syndrome (TSS) or macrophage activation syndrome (MAS) or unspecified inflammatory syndrome;
Key exclusion criteria (2 listed)
- other infectious and non-infectious causes that could be responsible for the disease
- SARS-CoV-2 polymerase chain reaction (PCR) or serology result could have been positive or negative. Due to limited availability and reliability of serologic testing, proven or likely COVID-19 criterion was not a condition determining inclusion to the registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multisystem inflammatory syndrome in children (MIS-C)as in group description | Other | MIS-C |
Primary outcome
PICU
Time frame: 5 years
pediatric intensive care unit treatment need
3 secondary outcomes
Heart dysfunction
Time frame: 5 years
CAA
Time frame: 5 years
Hypotension
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
Natalia Dudek, MD contact
Magdalena Okarska-Napierała principal investigator
Medical University of Warsaw
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Medical University of Warsaw at 2 sites in Poland.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magdalena Okarska-Napierała, PhD (+48503065849, magda.okarska@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PICU (time frame: 5 years). 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 26 Mar 2021.