E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084401 |
E.1.2 | Term | COVID-19 respiratory infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pre- and two hours post-dose |
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E.5.2 | 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.
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E.5.2.1 | 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).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |