CTRI/2022/02/039887尚未招募2 期
A double blind, placebo controlled intervention study to evaluate the antiviral effect of a single nasal dose with LTX-109 3 percent gel,compared to placebo gel, in individuals with COVID-19 infection.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
This is a double-blind, placebo-controlled, interventional parallel group study with the aim to
evaluate the use of LTX-109 nasal gel for treatment of Coronavirus disease 2019 (COVID-19)
infection by application to the nasal cavity. Subjects will be randomised 1:1 to one single dose of
either active treatment (LTX-109 3% hydrogel) or matching placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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-
- •The positive result must be available no later than 6 days from initiation of symptoms, if any.
排除标准
- •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, 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.
结局指标
主要结局
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
时间窗: From baseline (pre-dose) to 2 hours (h) post-dose]
treatment compared to before treatment (set to 100)
时间窗: From baseline (pre-dose) to 2 hours (h) post-dose]
次要结局
- 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 AEs)
研究者
研究点 (2)
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