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COVID-19Phase 2/3INHERITNCT05204550

Intranasal Heparin Treatment to Reduce Transmission Among Household Contacts of COVID 19 Positive Adults and Children

A Phase 2/3 study testing unfractionated heparin and 0.9%sodium chloride in people with COVID-19, run by Murdoch Childrens Research Institute at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 5 to 100 years
Conditions the study is for
COVID-19
What is being tested?
unfractionated heparin and 0.9%sodium chloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
506 participants
Where
1 siteAustralia
Study dates
30 Jan 2023to 1 Apr 2026
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The Northern Hospital

    Epping, Victoria, 3076

Other trials in Australia

About this study

Official 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

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.

Read more

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.

Read the 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(PCR) or Rapid Antigen test (RAT) confirmed SARS-CoV-2 infection will be randomised so that all consenting people in that household receive intranasal heparin or placebo.

The rate of subsequent PCR confirmed SARS-CoV-2 infections in exposed households will be measured to determine the effect of intranasal heparin on reducing transmission to close contacts.

The rate of symptom development in all participants will be used to determine effect of treatment in preventing symptomatic disease The rate of hospitalisation of all participants will be measured to determine the effect of treatment on development of severe disease.

The presence of clinical neurological long COVID symptoms will be assessed at 6 and 12 months to determine the effect of treatment on long COVID.

Objectives Primary

  • To test the efficacy of early treatment and post exposure prophylaxis to reduce transmission to household contacts on SARS-CoV-2 PCR assay by day 10.

Secondary

  • To test the efficacy of intranasal heparin to reduce SARS-CoV-2 viral shedding: over 10 days from day of positive swab (health professional collected nasopharyngeal swab Day 3 and 5, and Day 10: self-administered anterior nasal swab swab days 1,2,3,4,5 and 10).
  • To test the safety of intranasal heparin for treatment of adult and children outpatients with SARS CoV-2 infection
  • To test whether intranasal heparin administration reduces symptomatic disease in index cases and household contacts
  • To test the impact of intranasal heparin on peak severity of illness.
  • Quantification of replication-competent virus.
  • To assess the impact of intranasal heparin on long COVID neurological symptoms
Conditions
COVID-19
Being tested
unfractionated heparin, 0.9%sodium chloride
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • unfractionated heparinDrug

    Also called heparin

    intranasal

  • 0.9%sodium chlorideDrug

    Also called normal saline

    intranasal

Study groups in NCT05204550
Study groupRoleWhat they receive
intranasal heparinExperimentalUnfractionated 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)
Receives: Drug: unfractionated heparin
intranasal salinePlacebo comparatorComparator 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.
Receives: Drug: 0.9%sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    household contacts who become COVID 19 positive at any time during study period

    Measured: 14 days from randomisation

Secondary outcomes (15)

  1. Number of household contacts (swab negative on day 1 of study) becoming symptomatic of COVID-19 in next 28 days

    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).

    Measured: 28 days from randomisation

  2. total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 3

    proportion of COVID 19 positive participants becoming swab negative by day 3

    Measured: 3 days from randomisation

  3. total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 5

    proportion of COVID 19 positive participants becoming swab negative by day 5

    Measured: 5 days from randomisation

  4. total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 10

    proportion of COVID 19 positive participants becoming swab negative by day 10

    Measured: 10 days from randomisation

  5. Time to swab negative based on daily anterior nasal swab for index cases and household contacts combined who were swab positive on day 1.

    mean time to swab negative in all COVID 19 positive participants

    Measured: 10 days from randomisation

  6. Quantitative replication sub genomic viral RNA at days 3 post randomisation.

    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

    Measured: 3 days from randomisation

  7. Quantitative replication sub genomic viral RNA at days 5 post randomisation.

    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

    Measured: 5 days from randomisation

  8. Quantitative replication sub genomic viral RNA at days 10 post randomisation.

    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

    Measured: 10 days from randomisation

  9. The number of participants who discontinue treatment prior to day 10 from randomisation

    treatment tolerability

    Measured: 10 days from randomisation

  10. Number of index cases and household contacts swab positive on day 1, hospitalized with COVID-19 by day 28 from randomization

    symptomatic progression of COVID 19

    Measured: 28 days from randomisation

  11. Number of household contacts swab negative on day 1, hospitalized with COVID-19 by day 28 from randomization

    symptomatic progression of COVID 19

    Measured: 28 days from randomisation

  12. 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

    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

    Measured: 28 days from randomisation

  13. 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

    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.

    Measured: 28 days from randomisation

  14. Number of participants with clinical symptoms of neurological long COVID at 6 months post initial positive COVID-19 test.

    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

    Measured: 6 months from randomisation

  15. Number of participants with clinical symptoms of neurological long COVID at 12 months post initial positive COVID-19 test.

    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

    Measured: 12 months from randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start30 Jan 2023
  3. Primary completion9 Dec 2024
  4. Study completion1 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
506 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05204550
Sponsor's protocol ID
83609
Acronym
INHERIT
Status last verified
May 2026
First submitted
21 Jan 2022
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 32970989

  • 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.

    PubMed 33493448

  • 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.

    PubMed 32698853

  • 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.

    PubMed 32863274

  • 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.

    PubMed 33368089

  • 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.

    PubMed 33173010

  • 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.

    PubMed 19783956

  • 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.

    PubMed 26475409

  • 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.

    PubMed 34629893

  • 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.

    PubMed 12635579

  • 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.

    PubMed 11995261

  • 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.

    PubMed 34635560

  • 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.

    PubMed 34635561

  • Edwards K, Corocher T, Hersusianto Y, Campbell D, Subbarao K, Neil JA, Monagle P, Ho P. Heparin-mediated PCR interference in SARS-CoV-2 assays and subsequent reversal with heparinase I. J Virol Methods. 2024 Jun;327:114944. doi: 10.1016/j.jviromet.2024.114944. Epub 2024 Apr 20.

    PubMed 38649069

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing unfractionated heparin and 0.9%sodium chloride in people with COVID-19, run by Murdoch Childrens Research Institute at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 14 days from randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05204550, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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