COVID-19 MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: LTX-190 Hydrogel 3%
Pharmaceutical Form: Gel
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Nasal use
Sponsors
Pharma Holdings AS
Eligibility
Sex/Gender
All
Inclusion 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 (for definition see Section 9.6.1): ? Have to agree to use an acceptable birth control method during participation in the investigation (see Section 9.6.1). ? A negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Day 1 will be required. 4. A positive PCR 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 tonsilitis. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of a single dose of LTX-109 3% nasal gel on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load, as measured by a standardised reverse transcription quantitative polymerase chain reaction (RT-qPCR) method on the sample material after virus cultivation to quantify the amount of live virus in the samples, from the deep nasal cavity in subjects with COVID-19 infection, as compared to placebo.;Secondary Objective: 1. 1. To evaluate the effect of a single dose of LTX-109 3% nasal gel on SARS-CoV-2 viral load, as measured by a standardised RT-qPCR method on the sample material after virus cultivation to quantify the amount of live virus in the samples from the anterior nasal cavity in subjects with COVID-19 infection, as compared to placebo. 2. To evaluate safety and tolerability of a single dose of LTX-109 3% nasal gel, as compared to placebo. ;Primary end point(s): Reduction in SARS-CoV-2 viral load, based on the deep nasal swab sample, from baseline (pre-dose) to 2 hours (h) post-dose, as measured by a standardised RT-qPCR method after virus cultivation. Viral load will be expressed as relative amount of virions in samples after treatment compared to before treatment (set to 100). ;Timepoint(s) of evaluation of this end point: Pre- and two hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints 1. Reduction in SARS-CoV-2 viral load, based on the anterior nasal swab sample, from baseline (pre-dose) to 2 h post-dose, as measured by a standardised RT-qPCR method after virus cultivation. Viral load will be expressed as relative amount of virions in samples after treatment compared to before treatment (set to 100). 2. Frequency, intensity and seriousness of AEs. ;Timepoint(s) of evaluation of this end point: Pre- and two hours post dose for viral load. Through-out study until day 7 for safety (AEs). | — |
Countries
Sweden
Contacts
Public ContactCRM
CTC Clinical Trial Consultant
Outcome results
None listed