Overview
Sponsor-declared trial summary
Respiratory diseases
In patients diagnosed with COVID19, influenza A or RSV, analyze the immediate viricidal activity in saliva against these three respiratory viruses from a single rinse of different oral antiseptics, as well as the duration of this effect up to 7 hours after application.
Key facts
- Sponsor
- Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2025-04-14
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Instituto de Salud Carlos III (ICI21/00051)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
In patients diagnosed with COVID19, influenza A or RSV, analyze the immediate viricidal activity in saliva against these three respiratory viruses from a single rinse of different oral antiseptics, as well as the duration of this effect up to 7 hours after application.
Conditions and MedDRA coding
Respiratory diseases
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-515939-30-00 | Clinical trial on the virucidal activity of different oral antiseptics against respiratory viruses. | Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Present a diagnosis of infection by these respiratory viruses.
- Less than 5 days have passed since the appearance of the clinical symptoms typical of each viral infection.
- Not receiving any type of antiviral treatment.
- Be over 16 years old.
Exclusion criteria 3
- Pregnant.
- Present a history of allergy to the antiseptics evaluated.
- Simultaneous therapy with lithium, presence of hyperthyroidism, goiter, thyroid nodules, or other acute and non-acute thyroid diseases, before or after radioactive iodine scintigraphy or treatment of thyroid carcinoma with radioactive iodine, practice of tests with tolvidin or guaiacol, to determine hemoglobin or glucose in feces or urine.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Viral load in the salivary samples collected from each of the patients at the different times of application of the mouthwashes.
- D/T ratio (where D is the amount of nucleoprotein with the PBS solution and T is the amount of nucleoprotein with the lytic solution), which represents the reciprocal relationship between the enveloped nucleoprotein and the total nucleoprotein (I/T) and corresponds to I/T = 1 -D/T. In this case, the I/T ratio serves to quantify the proportion of intact viral particles.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Agua oxigenada Foret 3 % solución cutánea y concentrado para solución bucal
PRD4755133 · Product
- Active substance
- Hydrogen Peroxide
- Pharmaceutical form
- CUTANEOUS SOLUTION/CONCENTRATE FOR OROMUCOSAL SOLUTION
- Route of administration
- BUCCAL USE
- Max daily dose
- 0.15 mg milligram(s)
- Max total dose
- 015 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- D08AX01 — HYDROGEN PEROXIDE
- Marketing authorisation
- 40859
- MA holder
- PEROXFARMA
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Betadine bucal 100 mg/ml solución bucal
PRD9523249 · Product
- Active substance
- Povidone, Iodinated
- Substance synonyms
- Poly(1-(2-oxo-1-pyrrolidinyl)ethylene)iodine complex, POVIDONE IODINE, IODINATED POVIDONE, PVP-IODINE, POVIDONE-IODINE, POLYVIDONE-IODINE, POLYVINYLPYRROLIDONE-IODINE COMPLEX
- Pharmaceutical form
- GARGLE
- Route of administration
- BUCCAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R02AA15 — POVIDONE-IODINE
- Marketing authorisation
- 36339
- MA holder
- MEDA PHARMA S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Agua para preparaciones inyectables Meinsol, disolvente para uso parenteral
PRD2412886 · Product
- Active substance
- Water for Injection
- Pharmaceutical form
- SOLVENT FOR PARENTERAL USE
- Route of administration
- BUCCAL USE
- Max daily dose
- 20 g/ml gram(s)/millilitre
- Max total dose
- 20 g/ml gram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 58.935
- MA holder
- FRESENIUS KABI ESPAÑA S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
- Sponsor organisation
- Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
- Address
- Travesia Da Choupana S/n
- City
- Santiago De Compostela
- Postcode
- 15706
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
- Contact name
- Inma Tomás Carmona
Public contact point
- Organisation
- Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
- Contact name
- FIDIS
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 810 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | ORALANTISEPTIC_VIRUS_Protocolo | 6 |
| Recruitment arrangements (for publication) | ORALANTISEPTIC_VIRUS_Metodos de reclutamiento | 1 |
| Subject information and informed consent form (for publication) | ORALANTISEPTIC_VIRUS_Hoja informacion_consentimiento_changes_for pub | 6 |
| Subject information and informed consent form (for publication) | ORALANTISEPTIC_VIRUS_Hoja informacion_consentimiento_CLEAN_for pub | 6 |
| Summary of Product Characteristics (SmPC) (for publication) | ORALANTISEPTIC_VIRUS_FichaTecnica_Peroxido hidrogeno | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | ORALANTISEPTIC_VIRUS_FichaTecnica_Povidona iodada | 1 |
| Synopsis of the protocol (for publication) | ORALANTISEPTIC_VIRUS_Resumen en ingles | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-13 | Spain | Acceptable 2025-04-07
|
2025-04-14 |