COVID-19SPICENCT06434701
Severe COVID-19 Infection in Children Presenting to EDs in Israel and England
A study testing Nasopharyngeal swab sampling for COVID-19 in people with COVID-19 and Inflammatory Response, run by Hadassah Medical Organization at 6 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- COVID-19, Inflammatory Response
- What is being tested?
- Nasopharyngeal swab sampling for COVID-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 6 sitesIsrael
- Study dates
- 30 Sep 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Israel6 sites, 6 recruiting
- Recruiting
Haemek Medical Center
Afula
Ron Jacob, MD
- Recruiting
Soroka Medical Center
Beersheba
Or Kaplan, MD
- Recruiting
Hadassah Medical Center
Jerusalem
Maor Havkin, MD
- Recruiting
Shaare Zedek Medical Center
Jerusalem
Giora Weiser, MD
- Recruiting
Meir Medical Center
Kfar Saba
Nir Friedman, MD
- Recruiting
Sheba Medical Center
Tel HaShomer
Jordanna Koppel, MD
About this study
Official title: Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England: A Prospective Multicenter Study
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
- COVID-19, Inflammatory Response
- Being tested
- Nasopharyngeal swab sampling for COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swab sampling for COVID-19Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Severe acute COVID-19 infection | Experimental | Nasopharyngeal swab sampling for COVID-19 Receives: Diagnostic Test: Nasopharyngeal swab sampling for COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe acute COVID-19 infection (SACI)
The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department
Measured: Up to 16 weeks
Secondary outcomes (7)
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
Measured: Up to 12 weeks
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
Measured: Up to 12 weeks
Treatment with mechanical ventilation
The percentage of COVID-19 patients treated with mechanical ventilation among all patients admitted to the Emergency Department
Measured: Up to 12 weeks
Treatment with extracorporeal membrane oxygenation (ECMO)
The percentage of COVID-19 patients treated with ECMO among all patients admitted to the Emergency Department
Measured: Up to 8 weeks
Treatment with vasopressor support
The percentage of COVID-19 patients treated with vasopressor support among all patients admitted to the Emergency Department
Measured: Up to 8 weeks
Length of ICU stay
Mean duration of ICU stay for patients admitted with COVID-19
Measured: Up to 16 weeks
Length of hospital stay
Mean duration of hospital stay for patients admitted with COVID-19
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start30 Sep 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- London North West Healthcare NHS Trust
- Responsible party
- Principal investigator, Itai Shavit, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434701
- Sponsor's protocol ID
- SPICE-HMO-CTIL
- Acronym
- SPICE
- Status last verified
- Mar 2025
- First submitted
- 21 May 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06434701
- Acronym / sponsor ID
- SPICE / SPICE-HMO-CTIL
- Conditions
- COVID-19, Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- London North West Healthcare NHS Trust
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe acute COVID-19 infection | Experimental | Diagnostic Test: Nasopharyngeal swab sampling for COVID-19Nasopharyngeal swab sampling for COVID-19 |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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:
- MIS-C Patients aged 16 years or younger diagnosed with MIS-C
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal swab sampling for COVID-19The 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. | Diagnostic test | Severe acute COVID-19 infection |
Primary outcome
Severe acute COVID-19 infection (SACI)
Time frame: Up to 16 weeks
The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department
7 secondary outcomes
Administration of low-flow oxygen therapy via nasal cannula or face mask
Time frame: Up to 12 weeks
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
Treatment with mechanical ventilation
Time frame: Up to 12 weeks
Treatment with extracorporeal membrane oxygenation (ECMO)
Time frame: Up to 8 weeks
Treatment with vasopressor support
Time frame: Up to 8 weeks
Length of ICU stay
Time frame: Up to 16 weeks
Length of hospital stay
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasopharyngeal swab sampling for COVID-19 in people with COVID-19 and Inflammatory Response, run by Hadassah Medical Organization at 6 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Itai Shavit, MD (00 972 50 2063239, shavit1@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe acute COVID-19 infection (SACI) (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.