Viewing Study NCT06434701



Ignite Creation Date: 2024-06-16 @ 11:49 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06434701
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-30
First Post: 2024-05-21

Brief Title: Severe COVID-19 Infection in Children Presenting to EDs in Israel and England
Sponsor: Hadassah Medical Organization
Organization: Hadassah Medical Organization

Study Overview

Official Title: Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England A Prospective Multicenter Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SPICE
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None