Severe COVID-19 Infection in Children Presenting to EDs in Israel and England
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-16
SponsorHadassah Medical Organization
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Nasopharyngeal swab sampling for COVID-19
Diagnostic testThe 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Severe acute COVID-19 infectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Severe acute COVID-19 infection (SACI)
The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department
Time frame
Up to 16 weeksSecondary outcomes
1
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
Time frame
Up to 12 weeks2
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
Time frame
Up to 12 weeks3
Treatment with mechanical ventilation
The percentage of COVID-19 patients treated with mechanical ventilation among all patients admitted to the Emergency Department
Time frame
Up to 12 weeks4
Treatment with extracorporeal membrane oxygenation (ECMO)
The percentage of COVID-19 patients treated with ECMO among all patients admitted to the Emergency Department
Time frame
Up to 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hadassah Medical Organization
Lead sponsor
London North West Healthcare NHS Trust
Collaborator
Source ClinicalTrials.gov