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

March 11, 2025 updated by: Itai Shavit, Hadassah Medical Organization

Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England: A Prospective Multicenter Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Afula, Israel
        • Recruiting
        • HaEmek Medical Center
        • Contact:
          • Ron Jacob, MD
      • Be'er Sheva, Israel
        • Recruiting
        • Soroka Medical Center
        • Contact:
          • Or Kaplan, MD
      • Jerusalem, Israel
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:
          • Giora Weiser, MD
      • Jerusalem, Israel
        • Recruiting
        • Hadassah Medical Center
        • Contact:
          • Maor Havkin, MD
      • Kfar Saba, Israel
        • Recruiting
        • Meir Medical Center
        • Contact:
          • Nir Friedman, MD
      • Tel HaShomer, Israel
        • Recruiting
        • Sheba Medical Center
        • Contact:
          • Jordanna Koppel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Severe acute COVID-19 infection
Nasopharyngeal swab sampling for COVID-19
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe acute COVID-19 infection (SACI)
Time Frame: Up to 16 weeks
The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Administration of low-flow oxygen therapy via nasal cannula or face mask
Time Frame: Up to 12 weeks
The percentage of COVID-19 patients treated with low-flow oxygen among all patients admitted to the Emergency Department
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
Time Frame: Up to 12 weeks
The percentage of COVID-19 patients treated with HFNC or CPAP among all patients admitted to the Emergency Department
Up to 12 weeks
Treatment with mechanical ventilation
Time Frame: Up to 12 weeks
The percentage of COVID-19 patients treated with mechanical ventilation among all patients admitted to the Emergency Department
Up to 12 weeks
Treatment with extracorporeal membrane oxygenation (ECMO)
Time Frame: Up to 8 weeks
The percentage of COVID-19 patients treated with ECMO among all patients admitted to the Emergency Department
Up to 8 weeks
Treatment with vasopressor support
Time Frame: Up to 8 weeks
The percentage of COVID-19 patients treated with vasopressor support among all patients admitted to the Emergency Department
Up to 8 weeks
Length of ICU stay
Time Frame: Up to 16 weeks
Mean duration of ICU stay for patients admitted with COVID-19
Up to 16 weeks
Length of hospital stay
Time Frame: Up to 24 weeks
Mean duration of hospital stay for patients admitted with COVID-19
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

London North West Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPICE-HMO-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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