Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-01-14 @ 2:47 AM
Study NCT ID:
NCT04854928
Status:
UNKNOWN
Last Update Posted:
2021-09-20
First Post:
2021-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate a Single Dose of LTX-109 in Subjects With COVID-19 (Coronavirus Disease 2019) Infection.
Sponsor:
Pharma Holdings AS
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: