Severe COVID-19 Infection in Children Presenting to EDs in Israel and England
NCT ID: NCT06434701
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2024-09-30
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Severe acute COVID-19 infection
Nasopharyngeal swab sampling for COVID-19
Nasopharyngeal swab sampling for COVID-19
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.
Interventions
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Nasopharyngeal swab sampling for COVID-19
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
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Inclusion Criteria
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
2. MIS-C Patients aged 16 years or younger diagnosed with MIS-C
0 Years
16 Years
ALL
No
Sponsors
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London North West Healthcare NHS Trust
OTHER
Hadassah Medical Organization
OTHER
Responsible Party
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Itai Shavit
Chair, Division of Pediatrics, Hadassah Medical Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Ron Jacob, MD
Role: primary
Or Kaplan, MD
Role: primary
Maor Havkin, MD
Role: primary
Giora Weiser, MD
Role: primary
Nir Friedman, MD
Role: primary
Jordanna Koppel, MD
Role: primary
Other Identifiers
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SPICE-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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