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Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19

NCT04357990 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2022-07-06

No results posted yet for this study

Summary

Viruxal Oral and Nasal Spray is a Class I CE marked medical device manufactured by Kerecis hf (the "Device"). A double blind clinical trial will be conducted to evaluate the Device against placebo in COVID-19 positive, symptomatic patients in Iceland. Immediate access to COVID-19 patients is available through a well-organized COVID-19 outpatient follow-up clinic. Up to 128 patients with mild to moderate symptoms of COVID-19 will be recruited (so called "higher end of the low risk group"). These patients will be positive for COVID-19, be symptomatic with upper respiratory symptoms, but without involvement of the entire respiratory system. The patients will be randomized to receive treatment with the Study Device or to receive placebo. 64 patients will be randomized into the Study Device group and 64 patients into the Control group. Patients will administer Study Device or Control for 14 days and will have their symptoms recorded until no further symptoms are reported, up to a maximum of 28 days follow-up.

Conditions

Interventions

DEVICE

Viruxal Oral and Nasal Spray

Viruxal Oral and Nasal Spray is a Class I CE marked medical device manufactured by Kerecis hf. The Device contains Omega3 Viruxide. The main components in Omega3 Viruxide are Neem oil and St. John's Wort oil. The Device is administered from a pressurized canister into the oral and nasal cavity, where it creates a physical barrier for temporary protection of the mucosal tissue.

OTHER

Placebo

The placebo will be a similar spray containing saline only.

Sponsors & Collaborators

  • Kerecis Ltd.

    lead INDUSTRY

Principal Investigators

  • Ragnar F Ingvarsson, MD · Landspitalinn University Hospital, Iceland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-04
Primary Completion
2020-10-30
Completion
2020-10-30

Countries

  • Iceland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04357990 on ClinicalTrials.gov