Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Drug Product: 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 distr
Sponsors
Pharma Holdings AS
Parexel International Clinical Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Willing and able to give signed informed consent for participation in the study 2)Male or female subject greater than or equal to 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 -A negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Day 1 will be required. Country specific India: Serum pregnancy test will be used instead of urine 4) Asymptomatic or mildly infected COVID-19 patients as per Indian guidelines for Indian sites. NIH criteria will be used for Sweden 5) Duration of symptoms not exceeding 6 days prior to baseline/IMP administration (Day 1) 6) A positive RT-PCR test no older than 72 hours for SARS-CoV-2. The positive result must be available no later than 6 days from initiation of symptoms, if any
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 subjectâ??s ability to participate in the study 2)Other upper respiratory tract infection with concomitant symptoms that can influence the results, as judged by the Investigator 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 1 day 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) Moderate or severe COVID-19 infection as per guidelines 9)Any systemic anti-viral treatment within the last 4 weeks prior to Day 1 and during the study 10) Pregnant, nursing or actively trying to conceive a child 11) Inability to take medications nasally 12) In situ nasal jewellery or open nasal piercings 13) Planned treatment or treatment with another investigational drug within 30 days prior to Day 1 14) Subjects consented and screened but not dosed in previous Phase I studies are not excluded 15) Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in SARS-CoV-2 viral load, based on the deep nasal swab sample 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: From baseline (pre-dose) to 2 hours (h) post-dose] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Reduction in SARS-CoV-2 viral load, based on the anterior nasal swab sample 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 AEsTimepoint: 1) from baseline (pre-dose) to 2 h post-dose 2) From dosing until 7 days after dose | — |
Countries
India, Sweden
Contacts
Public ContactDr Annappa Kamath
Parexel International Clinical Research Private Limited
Outcome results
None listed