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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
Date last updated
9/04/2025

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
Assessment method [1] 0 0
household contacts who become COVID 19 positive at any time during study period
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
Assessment method [1] 0 0
household contacts who develop symptomatic COVID 19 defined as : fever (=38°C) PLUS =1 respiratory symptom (sore throat, cough, shortness of breath); OR 2 respiratory symptoms (sore throat, cough, shortness of breath); OR 1 respiratory symptom (sore throat, cough, shortness of breath) PLUS =2 non-respiratory symptoms (chills, nausea, vomiting, diarrhea, headache, conjunctivitis, myalgia, arthralgia, loss of taste or smell, fatigue or general malaise).
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
Assessment method [2] 0 0
proportion of COVID 19 positive participants becoming swab negative by 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
Assessment method [3] 0 0
proportion of COVID 19 positive participants becoming swab negative by 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
Assessment method [4] 0 0
proportion of COVID 19 positive participants becoming swab negative by 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.
Assessment method [5] 0 0
mean time to swab negative in all COVID 19 positive participants
Timepoint [5] 0 0
10 days from randomisation
Secondary outcome [6] 0 0
Quantitative replication sub genomic viral RNA at days 3 post randomisation.
Assessment method [6] 0 0
The quantitative assay to generate these data will be the Q2 SARS-CoV-2 Viral Load Quantitation Assay, with lower limit of quantification of 500 copies/ml and upper limit of quantification of 500,000,000 copies/ml. Results below or above these limits will be included in the mean and the mean change from baseline, with imputed value 499 and 500,000,001, respectively. High viral load is defined as \>106 copies/mL, low viral load is defined as =106 copies/mL, and undetectable viral load is defined as \< 500 copies/ml
Timepoint [6] 0 0
3 days from randomisation
Secondary outcome [7] 0 0
Quantitative replication sub genomic viral RNA at days 5 post randomisation.
Assessment method [7] 0 0
The quantitative assay to generate these data will be the Q2 SARS-CoV-2 Viral Load Quantitation Assay, with lower limit of quantification of 500 copies/ml and upper limit of quantification of 500,000,000 copies/ml. Results below or above these limits will be included in the mean and the mean change from baseline, with imputed value 499 and 500,000,001, respectively. High viral load is defined as \>106 copies/mL, low viral load is defined as =106 copies/mL, and undetectable viral load is defined as \< 500 copies/ml
Timepoint [7] 0 0
5 days from randomisation
Secondary outcome [8] 0 0
Quantitative replication sub genomic viral RNA at days 10 post randomisation.
Assessment method [8] 0 0
The quantitative assay to generate these data will be the Q2 SARS-CoV-2 Viral Load Quantitation Assay, with lower limit of quantification of 500 copies/ml and upper limit of quantification of 500,000,000 copies/ml. Results below or above these limits will be included in the mean and the mean change from baseline, with imputed value 499 and 500,000,001, respectively. High viral load is defined as \>106 copies/mL, low viral load is defined as =106 copies/mL, and undetectable viral load is defined as \< 500 copies/ml
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
Assessment method [9] 0 0
treatment tolerability
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
Assessment method [10] 0 0
symptomatic progression of COVID 19
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
Assessment method [11] 0 0
symptomatic progression of COVID 19
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
Assessment method [12] 0 0
A COVID-19 Composite Subjective Symptom Severity Score will be generated using the 11 common symptoms for COVID 19 infection listed at the Center for disease control website and a self-rated symptom severity assessment generated for each symptom on a daily basis using a Likert scale for each symptom (Scale 0-3: not present mild, moderate, severe). Common symptoms: * Fever or chills * Cough * Shortness of breath or difficulty breathing * Fatigue * Muscle or body aches * Headache * New loss of taste or smell * Sore throat * Congestion or runny nose * Nausea or vomiting * Diarrhea Index cases and household contacts will be asked to complete symptom severity checklists daily. Analysis will utilise a summative score
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
Assessment method [13] 0 0
hazard ratio of time to sustained improvement or resolution of symptoms based on daily symptoms reports up to day 28 specific to the 11 common symptoms for COVID 19 infection listed at the Center for Disease Control website and a self-rated symptom severity assessment generated for each symptom on a daily basis using a Likert scale for each symptom (Scale 0-3: not present mild, moderate, severe). Common symptoms: * Fever or chills * Cough * Shortness of breath or difficulty breathing * Fatigue * Muscle or body aches * Headache * New loss of taste or smell * Sore throat * Congestion or runny nose * Nausea or vomiting * Diarrhea Index cases and household contacts will be asked to complete symptom severity checklists daily.
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.
Assessment method [14] 0 0
Telehealth self-rated symptom assessment using a Likert scale(0-3: absent, mild, moderate, severe). for each symptom Symptoms screened: fatigue, malaise, daytime tiredness, impaired concentration, brain fog, sleep disturbance, forgetfulness, confusion, Headache, dizziness, nausea, Hypo/anosmia , hypo/ageusia, Impaired walking, tingling feet or hands, burning feet or hands, numb feet or hands, impaired fine motor skills, muscle pain, Epilepsy, anxiety, depression. Cognition and mood will be assessed using the harmonised procedures developed by the Neuro-COVID Neuropsychology International Task force. Telephone - Montreal Cognitive Assessment,Patient's Assessment of Own Functioning, Wechsler Adult Intelligence Scale, Digit Span (Forward and Backward),Brief Visuospatial Memory Test - Revised,Hopkins Verbal Learning Test, Depression, Anxiety, Stress Scales
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.
Assessment method [15] 0 0
Telehealth self-rated symptom assessment using a Likert scale(0-3: absent, mild, moderate, severe). for each symptom Symptoms screened: fatigue, malaise, daytime tiredness, impaired concentration, brain fog, sleep disturbance, forgetfulness, confusion, Headache, dizziness, nausea, Hypo/anosmia , hypo/ageusia, Impaired walking, tingling feet or hands, burning feet or hands, numb feet or hands, impaired fine motor skills, muscle pain, Epilepsy, anxiety, depression. Cognition and mood will be assessed using the harmonised procedures developed by the Neuro-COVID Neuropsychology International Task force. Telephone - Montreal Cognitive Assessment,Patient's Assessment of Own Functioning, Wechsler Adult Intelligence Scale, Digit Span (Forward and Backward),Brief Visuospatial Memory Test - Revised,Hopkins Verbal Learning Test, Depression, Anxiety, Stress Scales
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
Active, not 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
Accrual to date
Final
506
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
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Northern Hospital, Australia
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash University
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Peter Doherty Institute for Infection and Immunity
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
St Vincent's Hospital Melbourne
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
Email 0 0
Contact person for public queries
Name 0 0
Paul Monagle, MD
Address 0 0
Country 0 0
Phone 0 0
+61393455165
Email 0 0
paul.monagle@rch.org.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/50/NCT05204550/SAP_000.pdf


Results publications and other study-related documents

No documents have been uploaded by study researchers.

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