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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
A Single dose of LTX-109 gel will be applied topically to both nostrils by a qualified health professional. A large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.
A Single dose of placebo gel will be applied topically to both nostrils by a qualified health professional. A large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.
ClinSmart Sweden AB
Uppsala, Sweden
RECRUITINGReduction in Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2 ) viral load in the deep nasal cavity as measured by the amount of live virus in the samples.
Assessment of viral load at baseline (pre-dose) and 2h post-dose to evaluate the effect of a single dose of LTX-109 nasal gel as compared to placebo. Reduction in SARS-CoV-2 viral load is measured by a standardised reverse transcription quantitative polymerase chain reaction (RT-qPCR) method and virus titration followed by cell viability assay to quantify the amount of live virus in the samples (Median Tissue Culture Infectious Dose \[TCID50\]). Viral load will be expressed as TCID50/mL.
Time frame: From baseline (pre-dose) to 2 hours (h) post-dose
Reduction in SARS-CoV-2 viral load in the anterior nasal cavity as measured by the amount of live virus in the samples.
Assessment of viral load at baseline (pre-dose) and 2h post-dose to evaluate the effect of a single dose of LTX-109 nasal gel as compared to placebo. Reduction in SARS-CoV-2 viral load is measured by a standardised RT-qPCR method and virus titration followed by cell viability assay to quantify the amount of live virus in the samples, TCID50. Viral load will be expressed as TCID50/mL.
Time frame: From baseline (pre-dose) to 2 hours (h) post-dose
Assessment of safety and tolerability by frequency and seriousness of Adverse Events (AE)
The Investigator will assess the seriousness of all AE according to the common definition of Serious Adverse Events (SAE). Frequency of AEs and SAEs will be summarised by treatment and overall.
Time frame: From dosing until 7 days after dose.
Assessment of safety and tolerability by intensity of AE
The Investigator will assess the intensity of an AE on a 5 graded scale. Grade refers to the severity of the AE, from Grade 1 (mild) through Grade 5 (death).
Time frame: From dosing until 7 days after dose.
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