Clinical trial • Phase IV • Infectious Disease

Povidone-iodine for COVID-19 | Influenza A | Respiratory syncytial virus infection

Phase IV trial of Povidone-iodine for COVID-19 | Influenza A | Respiratory syncytial virus infection.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
COVID-19 | Influenza A | Respiratory syncytial virus infection
Trial Stage
Phase IV
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
13-12-2024
First CTIS Authorization Date
14-04-2025

Trial design

Placebo: Agua para preparaciones inyectables Meinsol, disolvente para uso parenteral (water for injection) — route: BUCCAL USE; maxTotalDoseAmount: 20 (g/ml) (as recorded in product entry).-controlled Phase IV trial across 1 site in Spain.

Comparator
Placebo: Agua para preparaciones inyectables Meinsol, disolvente para uso parenteral (water for injection) — route: BUCCAL USE; maxTotalDoseAmount: 20 (g/ml) (as recorded in product entry).
Target Sample Size
810
Trial Duration For Participant
0.2916667

Eligibility

Recruits 810 paediatric patients.

Pregnancy Exclusion
Pregnant.
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information and informed consent forms are available in the documents list (ORALANTISEPTIC_VIRUS_Hoja informacion_consentimiento_CLEAN_for pub; ORALANTISEPTIC_VIRUS_Hoja informacion_consentimiento_changes_for pub). No specific details on assent, age-specific consent procedures, or languages are provided in the record.

Inclusion criteria

  • {"criterion_text":"- Present a diagnosis of infection by these respiratory viruses.\n- Less than 5 days have passed since the appearance of the clinical symptoms typical of each viral infection.\n- Not receiving any type of antiviral treatment.\n- Be over 16 years old."}

Exclusion criteria

  • {"criterion_text":"- Pregnant.\n- Present a history of allergy to the antiseptics evaluated.\n- 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 endpoints

  • {"endpoint_text":"- Viral load in the salivary samples collected from each of the patients at the different times of application of the mouthwashes.","definition_or_measurement_approach":"Measurement of viral load in saliva samples collected at the different times after application of the mouthwashes."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Calculation of D/T and derived I/T ratio (I/T = 1 - D/T) to quantify proportion of intact viral particles based on nucleoprotein measurements with PBS (D) and lytic solution (T)."}

Recruitment

Planned Sample Size
810
Recruitment Window Months
17
Consent Approach
Informed consent forms are provided (documents: ORALANTISEPTIC_VIRUS_Hoja informacion_consentimiento_CLEAN_for pub; ORALANTISEPTIC_VIRUS_Hoja informacion_consentimiento_changes_for pub). The record does not specify assent procedures, age-specific consent documents, or languages.

Geography

Total Number Of Sites
1
Total Number Of Participants
810

Spain

Earliest CTIS Part Ii Submission Date
14-03-2025
Latest Decision Or Authorization Date
14-04-2025
Processing Time Days
31
Number Of Sites
1
Number Of Participants
810

Sites

Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Medicina Interna
Contact Person Name
María Jesús Domínguez Santalla
Contact Person Email
chusdominguez@gmail.com
Number Of Participants
810

Sponsor

Primary sponsor

Full Name
Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
Organisation Type
Patient organisation/association
Country Of Registered Address
Spain

Third parties

  • {"country":"","full_name":"Instituto de Salud Carlos III (ICI21/00051)","duties_or_roles":"Monetary support / funder","organisation_type":""}

Investigational products

Investigational Product Name
Betadine bucal 100 mg/ml solución bucal
Active Substance
Povidone-iodine
Modality
Small molecule
Routes Of Administration
Buccal use
Route
Buccal use
Authorisation Status
Authorised in ES (marketing authorisation number: 36339)
Maximum Dose
300 mg (maxTotalDoseAmount: 300, doseUom: mg)
Investigational Product Name
Agua oxigenada Foret 3 % solución cutánea y concentrado para solución bucal
Active Substance
Hydrogen peroxide
Modality
Small molecule
Routes Of Administration
Buccal use
Route
Buccal use
Authorisation Status
Authorised in ES (marketing authorisation number: 40859)
Maximum Dose
0.15 mg (maxDailyDoseAmount recorded as 0.15, doseUom: mg)
Investigational Product Name
Agua para preparaciones inyectables Meinsol, disolvente para uso parenteral
Active Substance
Water for injection
Modality
Other
Routes Of Administration
Buccal use
Route
Buccal use
Authorisation Status
Authorised in ES (marketing authorisation number: 58.935)
Maximum Dose
20 g/ml (maxTotalDoseAmount: 20, doseUomTotal: g/ml)

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