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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05204550
Registration number
NCT05204550
Ethics application status
Date submitted
21/01/2022
Date registered
24/01/2022
Date last updated
2/02/2024
Titles & IDs
Public title
Intranasal Heparin Treatment to Reduce Transmission Among Household Contacts of COVID 19 Positive Adults and Children
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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
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Secondary ID [1]
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83609
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Universal Trial Number (UTN)
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Trial acronym
INHERIT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID-19
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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household contacts who become COVID 19 positive at any time during study period
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Timepoint [1]
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14 days from randomisation
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Secondary outcome [1]
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Number of household contacts (swab negative on day 1 of study) becoming symptomatic of COVID-19 in next 28 days
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Assessment method [1]
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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).
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Timepoint [1]
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28 days from randomisation
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Secondary outcome [2]
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total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 3
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Assessment method [2]
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proportion of COVID 19 positive participants becoming swab negative by day 3
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Timepoint [2]
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3 days from randomisation
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Secondary outcome [3]
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total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 5
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Assessment method [3]
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proportion of COVID 19 positive participants becoming swab negative by day 5
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Timepoint [3]
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5 days from randomisation
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Secondary outcome [4]
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total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 10
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Assessment method [4]
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proportion of COVID 19 positive participants becoming swab negative by day 10
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Timepoint [4]
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10 days from randomisation
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Secondary outcome [5]
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Time to swab negative based on daily anterior nasal swab for index cases and household contacts combined who were swab positive on day 1.
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Assessment method [5]
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mean time to swab negative in all COVID 19 positive participants
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Timepoint [5]
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10 days from randomisation
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Secondary outcome [6]
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Quantitative replication sub genomic viral RNA at days 3 post randomisation.
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Assessment method [6]
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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
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Timepoint [6]
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3 days from randomisation
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Secondary outcome [7]
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Quantitative replication sub genomic viral RNA at days 5 post randomisation.
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Assessment method [7]
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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
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Timepoint [7]
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5 days from randomisation
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Secondary outcome [8]
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Quantitative replication sub genomic viral RNA at days 10 post randomisation.
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Assessment method [8]
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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
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Timepoint [8]
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10 days from randomisation
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Secondary outcome [9]
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The number of participants who discontinue treatment prior to day 10 from randomisation
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Assessment method [9]
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treatment tolerability
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Timepoint [9]
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10 days from randomisation
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Secondary outcome [10]
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Number of index cases and household contacts swab positive on day 1, hospitalized with COVID-19 by day 28 from randomization
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Assessment method [10]
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symptomatic progression of COVID 19
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Timepoint [10]
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28 days from randomisation
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Secondary outcome [11]
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Number of household contacts swab negative on day 1, hospitalized with COVID-19 by day 28 from randomization
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Assessment method [11]
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symptomatic progression of COVID 19
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Timepoint [11]
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28 days from randomisation
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Secondary outcome [12]
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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
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Assessment method [12]
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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
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Timepoint [12]
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28 days from randomisation
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Secondary outcome [13]
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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
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Assessment method [13]
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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.
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Timepoint [13]
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28 days from randomisation
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Secondary outcome [14]
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Number of participants with clinical symptoms of neurological long COVID at 6 months post initial positive COVID-19 test.
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Assessment method [14]
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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
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Timepoint [14]
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6 months from randomisation
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Secondary outcome [15]
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Number of participants with clinical symptoms of neurological long COVID at 12 months post initial positive COVID-19 test.
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Assessment method [15]
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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
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Timepoint [15]
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12 months from randomisation
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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.
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Minimum age
5
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2026
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Actual
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Sample size
Target
1100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Northern Hospital - Epping
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Recruitment postcode(s) [1]
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3076 - Epping
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Melbourne
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Northern Hospital, Australia
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Monash University
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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The Peter Doherty Institute for Infection and Immunity
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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St Vincent's Hospital Melbourne
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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Summary
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 infectious disease which carries a significant risk of death, has brought
massive economic impact globally and has proved hard to contain through public health
measures. While we currently have effective vaccines, they do not protect the whole community
and the constant threat of new mutations means there is an urgent need to identify new
approaches to reducing community spread of infection.
Heparin is a naturally occurring sugar molecule which has been used for a century to treat a
range of medical problems including heart attacks, strokes, and blood clots. It has also been
investigated as a treatment for pneumonias. Recent research suggests it binds to the
SARS-CoV-2 virus in such a way it may reduce the virus' ability to enter cells. This may be
an important way to tackle the early stages of infection which occurs inside the nose.
Therefore, this medication could be used amongst people with early COVID-19 infection and
amongst their household contacts to reduce the rate of virus transmission during local
outbreaks. If proven effective there are many other potential uses as primary prophylaxis for
people working in high risk areas, for travel, for protection in high risk crowded
environments such as nightclubs, or sporting events. Heparin is safe, inexpensive, available
worldwide and if effective could be rapidly used across the world to slow progression of the
current pandemic.
Further there are recent studies suggesting that the risk of brain complications as part of
"long COVID", are directly related to the amount of virus in the nose. Reducing the viral
load in the nose is thought to be effective in reducing these "long COVID" complications.
This study will explore the effect of the intervention on viral load and long COVID.
In this study, researchers want to investigate this medicine in people who have been
identified by a COVID-19 swab test to be in the early stages of infection(defined as the
index case), and amongst their household contacts. Each participant would take the medicine
or a dummy control solution by spray into their nose three times a day for 10 days. The study
will investigate if there are fewer people who contract SARS-CoV-2 infection by day 10
amongst households who receive the medicine than households which receive the dummy control.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05204550
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Trial related presentations / publications
Clausen TM, Sandoval DR, Spliid CB, Pihl J, Perrett HR, Painter CD, Narayanan A, Majowicz SA, Kwong EM, McVicar RN, Thacker BE, Glass CA, Yang Z, Torres JL, Golden GJ, Bartels PL, Porell RN, Garretson AF, Laubach L, Feldman J, Yin X, Pu Y, Hauser BM, Caradonna TM, Kellman BP, Martino C, Gordts PLSM, Chanda SK, Schmidt AG, Godula K, Leibel SL, Jose J, Corbett KD, Ward AB, Carlin AF, Esko JD. SARS-CoV-2 Infection Depends on Cellular Heparan Sulfate and ACE2. Cell. 2020 Nov 12;183(4):1043-1057.e15. doi: 10.1016/j.cell.2020.09.033. Epub 2020 Sep 14.
Dixon B, Smith RJ, Campbell DJ, Moran JL, Doig GS, Rechnitzer T, MacIsaac CM, Simpson N, van Haren FMP, Ghosh AN, Gupta S, Broadfield EJC, Crozier TME, French C, Santamaria JD; CHARLI Study Group. Nebulised heparin for patients with or at risk of acute respiratory distress syndrome: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial. Lancet Respir Med. 2021 Apr;9(4):360-372. doi: 10.1016/S2213-2600(20)30470-7. Epub 2021 Jan 22.
van Haren FMP, Page C, Laffey JG, Artigas A, Camprubi-Rimblas M, Nunes Q, Smith R, Shute J, Carroll M, Tree J, Carroll M, Singh D, Wilkinson T, Dixon B. Nebulised heparin as a treatment for COVID-19: scientific rationale and a call for randomised evidence. Crit Care. 2020 Jul 22;24(1):454. doi: 10.1186/s13054-020-03148-2.
Conzelmann C, Muller JA, Perkhofer L, Sparrer KM, Zelikin AN, Munch J, Kleger A. Inhaled and systemic heparin as a repurposed direct antiviral drug for prevention and treatment of COVID-19. Clin Med (Lond). 2020 Nov;20(6):e218-e221. doi: 10.7861/clinmed.2020-0351. Epub 2020 Aug 30.
Mycroft-West CJ, Su D, Pagani I, Rudd TR, Elli S, Gandhi NS, Guimond SE, Miller GJ, Meneghetti MCZ, Nader HB, Li Y, Nunes QM, Procter P, Mancini N, Clementi M, Bisio A, Forsyth NR, Ferro V, Turnbull JE, Guerrini M, Fernig DG, Vicenzi E, Yates EA, Lima MA, Skidmore MA. Heparin Inhibits Cellular Invasion by SARS-CoV-2: Structural Dependence of the Interaction of the Spike S1 Receptor-Binding Domain with Heparin. Thromb Haemost. 2020 Dec;120(12):1700-1715. doi: 10.1055/s-0040-1721319. Epub 2020 Dec 23.
Tandon R, Sharp JS, Zhang F, Pomin VH, Ashpole NM, Mitra D, McCandless MG, Jin W, Liu H, Sharma P, Linhardt RJ. Effective Inhibition of SARS-CoV-2 Entry by Heparin and Enoxaparin Derivatives. J Virol. 2021 Jan 13;95(3):e01987-20. doi: 10.1128/JVI.01987-20. Print 2021 Jan 13.
Ozsoy Y, Gungor S, Cevher E. Nasal delivery of high molecular weight drugs. Molecules. 2009 Sep 23;14(9):3754-79. doi: 10.3390/molecules14093754.
Monagle K, Ryan A, Hepponstall M, Mertyn E, Monagle P, Ignjatovic V, Newall F. Inhalational use of antithrombotics in humans: Review of the literature. Thromb Res. 2015 Dec;136(6):1059-66. doi: 10.1016/j.thromres.2015.10.011. Epub 2015 Oct 9.
Figueroa JM, Lombardo ME, Dogliotti A, Flynn LP, Giugliano R, Simonelli G, Valentini R, Ramos A, Romano P, Marcote M, Michelini A, Salvado A, Sykora E, Kniz C, Kobelinsky M, Salzberg DM, Jerusalinsky D, Uchitel O. Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Postexposure Prophylaxis of COVID-19 in Hospital Personnel Dedicated to Patients Care with COVID-19 Disease. Int J Gen Med. 2021 Oct 1;14:6277-6286. doi: 10.2147/IJGM.S328486. eCollection 2021.
Stelmach I, Jerzynska J, Stelmach W, Majak P, Brzozowska A, Gorski P, Kuna P. The effect of inhaled heparin on airway responsiveness to histamine and leukotriene D4. Allergy Asthma Proc. 2003 Jan-Feb;24(1):59-65.
Stelmach I, Jerzynska J, Bobrowska M, Brzozowska A, Majak P, Kuna P. [The effect of inhaled heparin on post-leukotriene bronchoconstriction in children with bronchial asthma]. Pol Merkur Lekarski. 2002 Feb;12(68):95-8. Polish.
Valencia Sanchez C, Theel E, Binnicker M, Toledano M, McKeon A. Autoimmune Encephalitis After SARS-CoV-2 Infection: Case Frequency, Findings, and Outcomes. Neurology. 2021 Dec 7;97(23):e2262-e2268. doi: 10.1212/WNL.0000000000012931. Epub 2021 Oct 11.
Misra S, Kolappa K, Prasad M, Radhakrishnan D, Thakur KT, Solomon T, Michael BD, Winkler AS, Beghi E, Guekht A, Pardo CA, Wood GK, Hsiang-Yi Chou S, Fink EL, Schmutzhard E, Kheradmand A, Hoo FK, Kumar A, Das A, Srivastava AK, Agarwal A, Dua T, Prasad K. Frequency of Neurologic Manifestations in COVID-19: A Systematic Review and Meta-analysis. Neurology. 2021 Dec 7;97(23):e2269-e2281. doi: 10.1212/WNL.0000000000012930. Epub 2021 Oct 11.
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Public notes
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Contacts
Principal investigator
Name
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Paul Monagle, MD
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Address
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University of Melbourne
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Paul Monagle, MD
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Address
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Country
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Phone
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+61393455165
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05204550
Download to PDF