NCT06434701 Severe COVID-19 Infection in Children Presenting to EDs in Israel and England
| NCT ID | NCT06434701 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hadassah Medical Organization |
| Condition | COVID-19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2024-09-30 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06434701 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 16 Years, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06434701 currently recruiting?
Yes, NCT06434701 is actively recruiting participants. Contact the research team at shavit1@hadassah.org.il for enrollment information.
Where is the NCT06434701 trial being conducted?
This trial is being conducted at Afula, Israel, Beersheba, Israel, Jerusalem, Israel, Jerusalem, Israel and 2 additional locations.
Who is sponsoring the NCT06434701 clinical trial?
NCT06434701 is sponsored by Hadassah Medical Organization. The trial plans to enroll 500 participants.
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