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Trial registered on ANZCTR


Registration number
ACTRN12624001339549p
Ethics application status
Not yet submitted
Date submitted
9/10/2024
Date registered
5/11/2024
Date last updated
5/11/2024
Date data sharing statement initially provided
5/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
COrticosteroids for Biphasic Reactions in Anaphylaxis - COBRA
Scientific title
Randomised control trial comparing incidence of biphasic anaphylaxis reactions, in patients who were successfully treated acute anaphylaxis, given oral Prednisone/Prednisolone at discharge compared to no corticosteroid therapy
Secondary ID [1] 313157 0
Nil
Universal Trial Number (UTN)
Trial acronym
COBRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaphylaxis 335434 0
Condition category
Condition code
Inflammatory and Immune System 331995 331995 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who are randomised to the treatment arm will be given a 2mg/kg dose of oral corticosteroid, Prednisone if they can swallow tablets or Prednisolone suspension if they cannot, prior to discharge and a prescription for two days of the same steroid and dose to take at home.
All patients will also receive an adrenaline auto-injector device '(Epi-pen)' and a script for oral antihistamine, Cetirizine - dosing as per New Zealand Formulary for age, to take as required.
Intervention code [1] 329724 0
Treatment: Drugs
Comparator / control treatment
All patients will receive a script for, and education for use of, an adrenaline auto-injector device (Epi-pen). They will also be given a script for antihistamine to use as required.
Control group
Active

Outcomes
Primary outcome [1] 339592 0
Incidence of biphasic reaction with 72 hours of initial anaphylactic episode
Timepoint [1] 339592 0
72 hours post recruitment
Secondary outcome [1] 440538 0
Number of adrenaline doses received with biphasic reaction treatment
Timepoint [1] 440538 0
72 hours post recruitment
Secondary outcome [2] 440539 0
Rate of admission to hospital with biphasic reaction
Timepoint [2] 440539 0
72 hours post recruitment
Secondary outcome [3] 440540 0
Incidence of insomnia
Timepoint [3] 440540 0
72 hours post recruitment

Eligibility
Key inclusion criteria
Successfully treated acute anaphylaxis deemed safe for hospital discharge by the senior medical doctor overseeing the patients care.
A senior medical doctor will be defined as the doctor who would normally oversee a patients care and discharge during that shift. This will usually be the Senior Medical Officer (SMO), but maybe be a Senior Registrar, Medical Officer Special Scale (MOSS) or Fellow, especially during night shifts.
Anaphylaxis will be defined using the NIAID/FAAN criteria
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Weight under 15 kg
Received corticosteroids during treatment of initial reaction
Allergy to Prednisone/Prednisolone
- these patients can be put in non-treatment arm without randomisation
Unable to be followed up by research team
Unable to represent or seek urgent medical care due to geographic, communication or transport restraints

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2025
Actual
Date of last participant enrolment
Anticipated
4/08/2026
Actual
Date of last data collection
Anticipated
10/08/2026
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 26627 0
New Zealand
State/province [1] 26627 0
WAIKATO

Funding & Sponsors
Funding source category [1] 317599 0
Hospital
Name [1] 317599 0
Te Whatu Ora Waikato
Country [1] 317599 0
New Zealand
Primary sponsor type
Hospital
Name
Te Whatu Ora Waikato
Address
Country
New Zealand
Secondary sponsor category [1] 319909 0
None
Name [1] 319909 0
Address [1] 319909 0
Country [1] 319909 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316304 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316304 0
https://ethics.health.govt.nz/about/northern-a-health-and-disability-ethics-committee/
Ethics committee country [1] 316304 0
New Zealand
Date submitted for ethics approval [1] 316304 0
11/11/2024
Approval date [1] 316304 0
Ethics approval number [1] 316304 0

Summary
Brief summary
There is significant debate amongst clinicians on whether corticosteroids should be prescribed for patients who have presented with anaphylaxis. On one hand you have an unknown amount of risk of a biphasic reaction, which can be as severe as the initial reaction, and the known side effect profile of corticosteroids on the other.
An appropriately powered, prospective randomised control trial, RCT, may help clinicians with this clinical decision and assist in both national and international guidelines on anaphylaxis treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137462 0
Dr Adrian Owen
Address 137462 0
Waikato Hospital, 183 Pembroke Street, Hamilton 3204
Country 137462 0
New Zealand
Phone 137462 0
+64221885215
Fax 137462 0
Email 137462 0
[email protected]
Contact person for public queries
Name 137463 0
Adrian Owen
Address 137463 0
Waikato Hospital, 183 Pembroke Street, Hamilton 3204
Country 137463 0
New Zealand
Phone 137463 0
+64221885215
Fax 137463 0
Email 137463 0
[email protected]
Contact person for scientific queries
Name 137464 0
Adrian Owen
Address 137464 0
Waikato Hospital, 183 Pembroke Street, Hamilton 3204
Country 137464 0
New Zealand
Phone 137464 0
+64221885215
Fax 137464 0
Email 137464 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.