## Protocol Section
### Identification Module
**NCT ID:** NCT06434701

**Acronym:** SPICE

**Brief Title:** 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

#### Organization Study ID Info
**ID:** SPICE-HMO-CTIL
#### Organization
**Class:** OTHER
**Full Name:** Hadassah Medical Organization
### Status Module
#### Completion Date
**Date:** 2026-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** London North West Healthcare NHS Trust

#### Lead Sponsor

**Class:** OTHER

**Name:** Hadassah Medical Organization

#### Responsible Party

**Investigator Affiliation:** Hadassah Medical Organization

**Investigator Full Name:** Itai Shavit

**Investigator Title:** Chair, Division of Pediatrics, Hadassah Medical Center

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- COVID-19

- Inflammatory Response

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SCREENING

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Nasopharyngeal swab sampling for COVID-19

**Intervention Names:**

- Diagnostic Test: Nasopharyngeal swab sampling for COVID-19

**Label:** Severe acute COVID-19 infection

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Severe acute COVID-19 infection

**Description:** 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.

**Name:** Nasopharyngeal swab sampling for COVID-19

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department

**Measure:** Severe acute COVID-19 infection (SACI)

**Time Frame:** Up to 16 weeks

#### Secondary Outcomes

**Description:** The percentage of COVID-19 patients treated with low-flow oxygen among all patients admitted to the Emergency Department

**Measure:** Administration of low-flow oxygen therapy via nasal cannula or face mask

**Time Frame:** Up to 12 weeks

**Description:** The percentage of COVID-19 patients treated with HFNC or CPAP among all patients admitted to the Emergency Department

**Measure:** 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

**Description:** The percentage of COVID-19 patients treated with mechanical ventilation among all patients admitted to the Emergency Department

**Measure:** Treatment with mechanical ventilation

**Time Frame:** Up to 12 weeks

**Description:** The percentage of COVID-19 patients treated with ECMO among all patients admitted to the Emergency Department

**Measure:** Treatment with extracorporeal membrane oxygenation (ECMO)

**Time Frame:** Up to 8 weeks

**Description:** The percentage of COVID-19 patients treated with vasopressor support among all patients admitted to the Emergency Department

**Measure:** Treatment with vasopressor support

**Time Frame:** Up to 8 weeks

**Description:** Mean duration of ICU stay for patients admitted with COVID-19

**Measure:** Length of ICU stay

**Time Frame:** Up to 16 weeks

**Description:** Mean duration of hospital stay for patients admitted with COVID-19

**Measure:** Length of hospital stay

**Time Frame:** Up to 24 weeks

### Eligibility Module

**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

**Maximum Age:** 16 Years

**Minimum Age:** 0 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** shavit1@hadassah.org.il

**Name:** Itai Shavit, MD

**Phone:** 00 972 50 2063239

**Role:** CONTACT

**Contact 2:**

**Email:** lhadas@hadassah.org.il

**Name:** Hadas Lamberg, PhD

**Phone:** 00 972 2 6777572

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007239

- Term: Infections

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

### Misc Info Module

- Version Holder: 2024-05-31
