Effectiveness of a Nasal Spray on Viral Respiratory Infections

COVID-19 Clinical Trial

Official title: Performance and Safety Assessment of HUMER STOP VIRUS Nasal Spray in Adults With Early Symptoms of Viral Respiratory Infection (COVID-19, Flu, Common Cold): an Open-label Randomized Controlled Study

Status Recruiting

Clinical Trial Summary

There is no cure for cold or flu, most people recover in about within two weeks. Paracetamol may be used to reduce aches or treat fever, headache, or body aches. Antiviral solutions ranging from simple universal saline solutions to novel compounds have been proposed to provide a temporary barrier to prevent viral infection and propagation.

The nasal spray "Humer Stop Virus" is indicated in patients presented with early symptoms of viral respiratory infection. This spray forms a protective barrier in the nasal mucosa which is the main entry of the upper air respiratory system viruses. The spray traps the viruses and helps the organism to eliminate them before they multiply themselves.

This clinical investigation is conducted to assess the performance, clinical benefit and safety of this nasal spray in patients with early symptoms of acute respiratory disease whether or not infection is related to common cold, flu or COVID virus. Indeed, presence of early symptoms of acute respiratory infection does not always imply viral infectionAntigen self-tests are available to confirm viral infection with flu viruses or severe acute respiratory syndrome (SARS-CoV-2). However, influenza and other winter viruses are not systematically searched for in general population, because this is of neither collective nor individual interest. To be as pragmatic as possible, we chose to assess performance and safety of the nasal spray on intended users in real conditions. Patients with early symptoms of cold, flu or COVID, are enrolled regardless their PCR test positivity confirming viral infection at the time of enrollment. For study needs, the primary endpoint, which aims to assess the performance of the nasal spray in terms of stopping the viral infection, is assessed in a subgroup of patients with a positive PCR test with flu, COVID or common cold virus in the nasal sample collected at enrollment.

Clinical Trial Description

Patients are recruited at the study site by the principal investigator, who gives a brief presentation of the study. Eligible, informed patients who sign a consent form are included and randomized.

All patients undergo three nasal swabs: at the time of enrolment, then 24 hours and 84 hours later, and complete a daily questionnaire on a secure mobile application dedicated to patient reported outcomes to assess their symptoms and provide information on any analgesic or antipyretic medication they may have been taking.

Patients randomized to the intervention group are asked to use the nasal spray as recommended and to report any difficulties with the device.

A final visit is organized on day 8 at the investigation center under the supervision of the investigator. ;

Related Conditions & MeSH terms

• Acute Respiratory Tract Infection
• Common Cold
• Communicable Diseases
• COVID-19
• Flu, Human
• Infections
• Influenza, Human
• Respiratory Tract Infections

• NCT number: NCT06278324
• Study type: Interventional
• Source: CEN Biotech
• Contact: Christine JUHEL, PhD
• Phone: 0033380680511
• Email: christine.juhel@groupecen.com
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2024
• Completion date: July 2024