Clinical trial NCT04854928: Study to Evaluate a Single Dose of LTX-109 in Subjects With COVID-19 (Coronavirus Disease 2019) Infection.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Keywords: LTX-109
COVID-19
Lead sponsor: Pharma Holdings AS
Sponsor class: INDUSTRY
Collaborators: name: CTC Clinical Trial Consultants AB
First posted: 2021-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, Double-blind, Placebo-controlled Randomization 1:1, active to placebo
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Willing and able to give electronically signed informed consent for participation in the study.
2. Male or female subject ≥18 years of age at screening.
3. Women of child-bearing potential have to agree to use an acceptable birth control method during participation in the investigation and a negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Day 1 will be required.
4. A positive PCR test (polymerase chain reaction test) or antigen test for SARS-CoV-2. The positive result must be available no later than 4 days from initiation of symptoms, if any.
5. Duration of symptoms not exceeding 6 days prior to baseline/IMP administration (Day 1).
6. Access to a mobile phone or computer and ability to use the electronic diary application and to participate in web-based appointments.

Exclusion Criteria:

1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
2. Other upper respiratory tract infection with concomitant symptoms that can influence the results, such as sinusitis or tonsillitis.
3. Known allergy or hypersensitivity to the components of the IMP.
4. Current use of immunosuppressive therapy within the last 4 weeks prior to Day 1 and during the study.
5. Current use of nasally administered drugs within the last 2 weeks prior to Day 1 and during the study.
6. Vaccinated against COVID-19 or scheduled for vaccination within the study period.
7. Previous COVID-19 infection.
8. Any systemic anti-viral treatment within the last 4 weeks prior to Day 1 and during the study.
9. Pregnant, nursing or actively trying to conceive a child.
10. Inability to take medications nasally.
11. In situ nasal jewellery or open nasal piercings.
12. Planned treatment or treatment with another investigational drug within 30 days prior to Day 1. Subjects consented and screened but not dosed in previous Phase I studies are not excluded.
13. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Primary outcomes:
measure: Reduction 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.
timeFrame: From baseline (pre-dose) to 2 hours (h) post-dose
Secondary outcomes:
measure: Reduction in SARS-CoV-2 viral load in the anterior nasal cavity as measured by the amount of live virus in the samples.
timeFrame: From baseline (pre-dose) to 2 hours (h) post-dose
measure: Assessment of safety and tolerability by frequency and seriousness of Adverse Events (AE)
timeFrame: From dosing until 7 days after dose.
measure: Assessment of safety and tolerability by intensity of AE
timeFrame: From dosing until 7 days after dose.
Other outcomes:
measure: Change in Symptom score for frequency of COVID-19 infection symptoms.
timeFrame: From pre-dose on Day 1 until Day 7.
measure: Change in Symptom score for intensity of COVID-19 infection symptoms.
timeFrame: From pre-dose on Day 1 until Day 7.
measure: Reduction in SARS-CoV-2 viral load in the deep nasal cavity as measured by qPCR.
timeFrame: From baseline (pre-dose) to 2 hours (h) post-dose
measure: Reduction in SARS-CoV-2 viral load in the anterior nasal cavity as measured by qPCR.
timeFrame: From baseline (pre-dose) to 2 hours (h) post-dose
Locations:
city: Uppsala
country: Sweden
facility: ClinSmart Sweden AB
Study officials:
affiliation: Pharma Holdings AS
name: Christian Lütken, MD
role: STUDY_DIRECTOR
References: