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

Hadassah Medical Center

Status: Enrolling

Conditions: COVID-19; Inflammatory Response

Treatments: Diagnostic Test: Nasopharyngeal swab sampling for COVID-19

Study type: Interventional

Funder types: Other

Identifiers

NCT06434701

SPICE-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Severe acute COVID-19 infection

Experimental group

Description:

Nasopharyngeal swab sampling for COVID-19

Treatment:

Diagnostic Test: Nasopharyngeal swab sampling for COVID-19