Clinical trial NCT06434701: Severe COVID-19 Infection in Children Presenting to EDs in Israel and England
Official title: Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England: A Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Inflammatory Response
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: London North West Healthcare NHS Trust
First posted: 2024-05-30
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility 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

Primary outcomes:
measure: Severe acute COVID-19 infection (SACI)
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Administration of low-flow oxygen therapy via nasal cannula or face mask
timeFrame: Up to 12 weeks
measure: Administration of high-flow oxygen via nasal cannula (HFNC), or administration of oxygen via bilevel or continuous positive airway pressure (CPAP) machine
timeFrame: Up to 12 weeks
measure: Treatment with mechanical ventilation
timeFrame: Up to 12 weeks
measure: Treatment with extracorporeal membrane oxygenation (ECMO)
timeFrame: Up to 8 weeks
measure: Treatment with vasopressor support
timeFrame: Up to 8 weeks
measure: Length of ICU stay
timeFrame: Up to 16 weeks
measure: Length of hospital stay
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
Study officials:
References: