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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05204550




Registration number
NCT05204550
Ethics application status
Date submitted
21/01/2022
Date registered
24/01/2022

Titles & IDs
Public title
Intranasal Heparin Treatment to Reduce Transmission Among Household Contacts of COVID 19 Positive Adults and Children
Scientific title
A Randomised, Placebo-controlled Trial to Investigate the Efficacy of Intranasal Heparin Treatment to Reduce Transmission of SARS-CoV-2 Infection and COVID 19 Disease Among Household Contacts of SARS-CoV-2+ Adults and Children
Secondary ID [1] 0 0
83609
Universal Trial Number (UTN)
Trial acronym
INHERIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - unfractionated heparin
Treatment: Drugs - 0.9%sodium chloride

Experimental: intranasal heparin - Unfractionated heparin (UFH) 1400u each nostril (as heparin solution 5,000u/ml, 140 microL/actuation, Two actuations each nostril) Three times daily via a plastic nasal inhalator device (APTAR, UK) for 10 days.

This is a maximal dose per day of UFH of 8400u. ie 700 x 2 actuations per nostril (1400 x2) 3 times per day (1400x2x3 = 8400u)

Placebo comparator: intranasal saline - Comparator 0.9% saline (as saline solution, 140 microlitres/actuation, Two actuations each nostril) Three times daily via a plastic nasal inhalator device(APTAR, UK) for 10 days.


Treatment: Drugs: unfractionated heparin
intranasal

Treatment: Drugs: 0.9%sodium chloride
intranasal
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of household contacts (swab negative on day 1) testing positive for SARS-CoV-2 by PCR on either of three routine nasopharyngeal swabs on day 3,5 and 10 after enrolment or on nasopharyngeal swab in response to clinical symptoms in the first 14 days
Timepoint [1] 0 0
14 days from randomisation
Secondary outcome [1] 0 0
Number of household contacts (swab negative on day 1 of study) becoming symptomatic of COVID-19 in next 28 days
Timepoint [1] 0 0
28 days from randomisation
Secondary outcome [2] 0 0
total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 3
Timepoint [2] 0 0
3 days from randomisation
Secondary outcome [3] 0 0
total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 5
Timepoint [3] 0 0
5 days from randomisation
Secondary outcome [4] 0 0
total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 10
Timepoint [4] 0 0
10 days from randomisation
Secondary outcome [5] 0 0
Time to swab negative based on daily anterior nasal swab for index cases and household contacts combined who were swab positive on day 1.
Timepoint [5] 0 0
10 days from randomisation
Secondary outcome [6] 0 0
Quantitative replication sub genomic viral RNA at days 3 post randomisation.
Timepoint [6] 0 0
3 days from randomisation
Secondary outcome [7] 0 0
Quantitative replication sub genomic viral RNA at days 5 post randomisation.
Timepoint [7] 0 0
5 days from randomisation
Secondary outcome [8] 0 0
Quantitative replication sub genomic viral RNA at days 10 post randomisation.
Timepoint [8] 0 0
10 days from randomisation
Secondary outcome [9] 0 0
The number of participants who discontinue treatment prior to day 10 from randomisation
Timepoint [9] 0 0
10 days from randomisation
Secondary outcome [10] 0 0
Number of index cases and household contacts swab positive on day 1, hospitalized with COVID-19 by day 28 from randomization
Timepoint [10] 0 0
28 days from randomisation
Secondary outcome [11] 0 0
Number of household contacts swab negative on day 1, hospitalized with COVID-19 by day 28 from randomization
Timepoint [11] 0 0
28 days from randomisation
Secondary outcome [12] 0 0
Maximum severity score of participants (index case and household contacts swab positive on day 1 compared to household contacts swab negative on day 1) during the study period as recorded by daily symptom diary up to day 28
Timepoint [12] 0 0
28 days from randomisation
Secondary outcome [13] 0 0
time to symptom resolution analysis for index case and household contacts swab positive on day 1 compared to household contacts swab negative on day 1, during the study period as measured with daily symptom diary until on day 28
Timepoint [13] 0 0
28 days from randomisation
Secondary outcome [14] 0 0
Number of participants with clinical symptoms of neurological long COVID at 6 months post initial positive COVID-19 test.
Timepoint [14] 0 0
6 months from randomisation
Secondary outcome [15] 0 0
Number of participants with clinical symptoms of neurological long COVID at 12 months post initial positive COVID-19 test.
Timepoint [15] 0 0
12 months from randomisation

Eligibility
Key inclusion criteria
* 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.
Minimum age
5 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
1100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 0 0
3076 - Epping

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Northern Hospital, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Peter Doherty Institute for Infection and Immunity
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
St Vincent's Hospital Melbourne
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Monagle, MD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul Monagle, MD
Address 0 0
Country 0 0
Phone 0 0
+61393455165
Fax 0 0
Email 0 0
paul.monagle@rch.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in the primary publication and subsequent publications(text, tables, figures, and appendices), after deidentification. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, Study Principal Investigators must see and approve the analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgement and any additional costs involved must be covered. Should the Study Principal Investigators be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognised research institution which has approved the proposed analysis plan.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
6 months after primary publication of the study data for 10 years
Available to whom?
1) Data access agreement; 2) Approval by Principal Investigators; 3) Recognised research institutions; 4) Project has received ethics approval
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mcri.edu.au/research/training-and-resources/launching-pad#_Data_Sharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05204550