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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 16
Healthy Volunteers: f
View:

• 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

• MIS-C Patients aged 16 years or younger diagnosed with MIS-C

Locations
Other Locations
Israel
Haemek Medical Center
RECRUITING
Afula
Soroka Medical Center
RECRUITING
Beersheba
Hadassah Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kfar Saba
Sheba Medical Center
RECRUITING
Tel Litwinsky
Contact Information
Primary
Itai Shavit, MD
shavit1@hadassah.org.il
00 972 50 2063239
Backup
Hadas Lamberg, PhD
lhadas@hadassah.org.il
00 972 2 6777572
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 500
Treatments
Experimental: Severe acute COVID-19 infection
Nasopharyngeal swab sampling for COVID-19
Related Therapeutic Areas
Sponsors
Collaborators: London North West Healthcare NHS Trust
Leads: Hadassah Medical Organization

This content was sourced from clinicaltrials.gov