Ireland
--:--IST
Recruiting Not applicable

Severe COVID-19 Infection in Children Presenting to EDs in Israel and England

NCT06434701 · tracked via the Priya Life Science Israel tracker
Phase
Not applicable
Started
2024-09-30
Last updated
2025-03-14

Condition(s) studied

COVID-19Inflammatory Response

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
16 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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 2. MIS-C Patients aged 16 years or younger diagnosed with MIS-C

Primary outcome measure(s)

  • Severe acute COVID-19 infection (SACI) — Up to 16 weeks
    The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department

Trial sites (6)

FacilityCityRegionStatus
Haemek Medical Center Afula Israel Recruiting
Soroka Medical Center Beersheba Israel Recruiting
Hadassah Medical Center Jerusalem Israel Recruiting
Shaare Zedek Medical Center Jerusalem Israel Recruiting
Meir Medical Center Kfar Saba Israel Recruiting
Sheba Medical Center Tel HaShomer Israel Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06434701 on ClinicalTrials.gov ↗ ← All trials in Israel