Status:
ACTIVE_NOT_RECRUITING
Intranasal Heparin Treatment to Reduce Transmission Among Household Contacts of COVID 19 Positive Adults and Children
Lead Sponsor:
Murdoch Childrens Research Institute
Collaborating Sponsors:
University of Melbourne
Northern Hospital, Australia
Conditions:
COVID-19
Eligibility:
All Genders
5-100 years
Phase:
PHASE2
PHASE3
Brief Summary
Coronavirus-induced disease 2019 (COVID-19) is an infection caused by a virus whose full name is severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This is a new and rapidly-spreading infec...
Detailed Description
Multi-centre, prospective, randomised, placebo-controlled two-arm cluster randomised superiority clinical trial. Individual households with at least one person with Polymerase chain reaction assay(PC...
Eligibility Criteria
Inclusion
- Any person \> 5 years of age who tests positive to SARS-CoV-2 or is a household contact of someone of any age who tests positive is eligible for the trial.
- Index case must be within 72 hours of positive test.
- The positive test can be a RAT or a standard PCR nasal swab performed at an accredited laboratory for the diagnosis of COVID-19 as per the department of health regulations. If initial test is a RAT, then a a standard PCR nasal swab performed at an accredited laboratory for the diagnosis of COVID-19 as per the department of health regulations will be collected prior to randomisation but does not delay entry into the study awaiting the confirmatory result.
- All participants must provide a signed and dated consent form and for children \< 16 years have a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Consent forms will be developed in multiple languages and provided in a language that the participants are fluent in speaking.
- At least one other person other than the index case in each household must consent to participation to enable the consenting members of the household to be randomised. Household members who do not consent to participate in the randomised trial but whom consent to have their COVID-19 status recorded can contribute to outcome measures where relevant.
Exclusion
- Children Age \< 5 years are excluded from being randomised to therapy but can contribute to the outcome measures if they are swab negative on day 1.
- Documented Heparin allergy
- Previous documented heparin induced thrombocytopenia (HIT)
- Recurrent epistaxis that has required hospitalisation in last 3 months
- \>72 hours since index case tested positive
- Inability to provide patient information and consent forms or study instructions in a language in which the patient is competent.
- Household members who are swab positive on day 1 are excluded from contributing to the primary outcome, but are randomised and still contribute to secondary outcomes
Key Trial Info
Start Date :
January 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT05204550
Start Date
January 30 2023
End Date
June 1 2026
Last Update
April 9 2025
Active Locations (1)
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1
The Northern Hospital
Epping, Victoria, Australia, 3076