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Study to Evaluate a Single Dose of LTX-109 in Subjects With COVID-19 (Coronavirus Disease 2019) Infection.

COVID-19 Clinical Trial

Official title:
A Double-blind, Placebo-controlled, Interventional Parallel Group Study to Evaluate the Antiviral Effect of a Single Nasal Application of LTX-109 3% Gel, in Comparison to Placebo Gel, in Subjects With COVID-19 Infection.

Clinical Trial Summary

A Phase IIa, double-blind, placebo-controlled, randomised study designed to evaluate the effect, safety and tolerability of LTX-109 administered topically to the anterior nares in subjects with COVID-19 infection.

Clinical Trial Description

A total of 60 subjects will be randomised to achieve approximately 46 completed and evaluable subjects. Subjects will be randomised 1:1 to one single dose of either active treatment or placebo. All potential study subjects will be contacted and invited to a screening video-call with the Investigator. Full verbal information will be given and the consent for participation in the study will be signed electronically. Eligible subjects will be visited twice at home by a study nurse on Day 1. During the first visit, one standard deep nose swab (one nostril) and one from the anterior part of the nose (both nostrils) will be collected. Symptom score will be assessed by the subject before dosing. The investigational medicinal product (IMP) will then be applied topically to both nostrils by the study nurse. The study nurse will come back to collect nasal swab samples 2 hours after administration of the IMP, using the same sampling procedure as for the baseline samples. Subjects will use an electronic diary for daily registrations of adverse events, concomitant medications and symptom score until Day 7. A follow-up phone contact will be performed 7 days after IMP administration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04854928
Study type Interventional
Source Pharma Holdings AS
Contact Christian Lütken, MD
Phone +47 48 000 242
Email Christian.lutken@pharmaholdings.no
Status Recruiting
Phase Phase 2
Start date May 3, 2021
Completion date May 2022
View Details
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