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

COVID-19 Clinical Trial

— SPICE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434701
• Other study ID #: SPICE-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2024
• Est. completion date: August 31, 2026

Study information

• Verified date: May 2024
• Source: Hadassah Medical Organization
• Contact: Itai Shavit, MD
• Phone: 00 972 50 2063239
• Email: shavit1[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Inflammatory Response

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	London North West Healthcare NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe acute COVID-19 infection (SACI)	The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department	Up to 16 weeks
Secondary	Administration of low-flow oxygen therapy via nasal cannula or face mask	The percentage of COVID-19 patients treated with low-flow oxygen among all patients admitted to the Emergency Department	Up to 12 weeks
Secondary	Administration of high-flow oxygen via nasal cannula (HFNC), or administration of oxygen via bilevel or continuous positive airway pressure (CPAP) machine	The percentage of COVID-19 patients treated with HFNC or CPAP among all patients admitted to the Emergency Department	Up to 12 weeks
Secondary	Treatment with mechanical ventilation	The percentage of COVID-19 patients treated with mechanical ventilation among all patients admitted to the Emergency Department	Up to 12 weeks
Secondary	Treatment with extracorporeal membrane oxygenation (ECMO)	The percentage of COVID-19 patients treated with ECMO among all patients admitted to the Emergency Department	Up to 8 weeks
Secondary	Treatment with vasopressor support	The percentage of COVID-19 patients treated with vasopressor support among all patients admitted to the Emergency Department	Up to 8 weeks
Secondary	Length of ICU stay	Mean duration of ICU stay for patients admitted with COVID-19	Up to 16 weeks
Secondary	Length of hospital stay	Mean duration of hospital stay for patients admitted with COVID-19	Up to 24 weeks