Severe COVID-19 Infection in Children Presenting to EDs in Israel and England
SPICE
1 other identifier
interventional
500
1 country
6
Brief Summary
Even though the COVID-19 pandemic is no longer at its peak, the threat still lingers. Engaging in prospective surveillance studies will enable us to monitor the disease and prepare for any potential resurgence. COVID-19 surveillance studies are essential tools for policymakers to make informed decisions, allocate resources, and develop strategies to control the spread of the virus and protect public health. The objective of this surveillance study is to prospectively assess in-hospital severe morbidity related to COVID-19 infection in children who present to the Pediatric Emergency Department (ED). A prospective multicenter study will be conducted across eight EDs in Israel and five EDs in the United Kingdom. The study population will include children aged 16 years or younger with a severe acute COVID-19 infection. Confirmation of acute COVID-19 infection will be based on polymerase chain reaction nasopharyngeal swab testing. The study will also include patients diagnosed with multisystem inflammatory syndrome in children (MIS-C), as defined by the CDC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Sep 2024
Longer than P75 for not_applicable covid19
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedStudy Start
First participant enrolled
September 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
March 14, 2025
March 1, 2025
1.9 years
May 21, 2024
March 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Severe acute COVID-19 infection (SACI)
The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department
Up to 16 weeks
Secondary Outcomes (7)
Administration of low-flow oxygen therapy via nasal cannula or face mask
Up to 12 weeks
Administration of high-flow oxygen via nasal cannula (HFNC), or administration of oxygen via bilevel or continuous positive airway pressure (CPAP) machine
Up to 12 weeks
Treatment with mechanical ventilation
Up to 12 weeks
Treatment with extracorporeal membrane oxygenation (ECMO)
Up to 8 weeks
Treatment with vasopressor support
Up to 8 weeks
- +2 more secondary outcomes
Study Arms (1)
Severe acute COVID-19 infection
EXPERIMENTALNasopharyngeal swab sampling for COVID-19
Interventions
The healthcare provider will gently insert the swab a short distance (1-1.5 cm for young children) into one nostril, reaching the back of the nasal cavity. The swab will then be gently rotated and rubbed for a few seconds to collect a sample of mucus. The same process may be repeated in the other nostril.
Eligibility Criteria
You may qualify if:
- SACI
- Patients aged 16 years or younger with a positive COVID-19 PCR nasopharyngeal swab testing or bronchoalveolar sample who meet the definition of SACI:
- Receive oxygen via low-flow nasal cannula or oxygen mask, high-flow nasal cannula, bilevel or continuous positive airway pressure machine, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) Or
- Admitted to ICU
- MIS-C Patients aged 16 years or younger diagnosed with MIS-C
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Haemek Medical Center
Afula, Israel
Soroka Medical Center
Beersheba, Israel
Hadassah Medical Center
Jerusalem, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
Sheba Medical Center
Tel Litwinsky, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair, Division of Pediatrics, Hadassah Medical Center
Study Record Dates
First Submitted
May 21, 2024
First Posted
May 30, 2024
Study Start
September 30, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
March 14, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share