NCT05722691已完成3 期
Double-Blind, Placebo-Controlled Multicentre Clinical Study for Efficacy and Safety Assessment of the Drug RADAMIN®VIRO for COVID-19 Postexposure Prophylaxis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 10
- 主要终点
- Confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19
研究概览
简要总结
This is Double-Blind, Placebo-Controlled Multicentre Clinical Phase III Study conducted in 10 medical facilities. The objective of the study is to evaluate efficacy and safety of the drug Drug RADAMIN®VIRO, Lyophilisate for Preparation of Solution for Intramuscular and Subcutaneous Administration for COVID-19 Postexposure Prophylaxis
详细描述
Upon signing the informed consent form and screening, 800 eligible subjects resides with a person with confirmed COVID-19 were randomized at a 1:1 ratio to receive either RADAMIN®VIRO once intramuscularly 5 mg (1 vial) or 1 vial of placebo once intramuscularly
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 18 to 80 inclusive (subjects) as of the time of signing the Subject Information Sheet (SIS) Informed Consent Form.
- •A subject resides with a person with confirmed COVID-19 who meets both of the following criteria:
- •The first positive result for SARS-CoV-2 RNA laboratory test with nucleic acid amplification techniques (NAAT) or SARS-CoV-2 antigen with immunochromatographic assay, obtained up to 72 hours prior to randomisation of a subject participating in the study.
- •At least one of the symptoms typical of COVID-19 is observed, with symptoms onset no more than 5 days prior to the randomisation of the subject participating in the study.
- •Negative result for antigen of SARS-CoV-2 with immunochromatographic assay.
- •No symptoms typical of COVID-19 observed.
- •A subject is expected to continue to reside with a person with confirmed COVID-19 during the entire clinical study period; hospitalisation of a person with officially confirmed COVID-19 is not needed at the time of study subject's randomisation.
- •Subject's consent to use reliable contraception methods during the entire study and for 3 weeks after the end of the study. Reliable contraception methods are: sexual abstinence, the use of a condom combined with a spermicidal agent. Female subjects incapable of bearing children (history: hysterectomy, tubal ligation, infertility, menopause for more than 2 years), as well as male subjects with infertility or a history of vasectomy may participate in the study.
- •Availability of SIS Informed Consent Form signed and dated by a patient.
- •Availability of Informed Consent Form for collection of information on COVID-19 signed and dated by a person with confirmed COVID-19.
排除标准
- •Hypersensitivity to the study drug components, procaine.
- •Contraindications to intramuscular injections.
- •Contact with 2 or more persons with confirmed COVID-19 within a month prior to screening or residing with 2 or more people with officially confirmed COVID-19 at the time of screening.
- •Joint residence with more than 10 people.
- •Laboratory-confirmed case of COVID-19 within 6 months prior to randomisation.
- •Vaccination against COVID-19 within less than 4 weeks prior to screening.
- •Use or necessity to use unauthorised pharmaceuticals at the time of screening.
- •Use of immunostimulatory, immunomodulatory, or immunosuppressive medications within 3 months prior to screening.
- •Subjects undergoing renal replacement therapy or with a history of severe renal insufficiency (estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, within 6 months prior to screening).
- •Primary biliary cirrhosis class C according to the Child - Pugh classification or a history of chronic or active hepatitis B or C.
- •Positive test result for HIV, syphilis, hepatitis B and/or C at the time of screening.
- •Chronic cardiac failure, Functional Class 3 III-IV according to the New York Heart Association (NYHA) Functional Classification.
- •A history of malignant tumours, except for subjects with disease being not observed within the last 5 years, subjects with completely cured basal cell skin cancer, or completely cured carcinoma in situ.
- •Alcohol, pharmacological and/or drug dependence (history and/or at the time of screening).
- •Schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder (history or suspected) at the time of screening.
- •Any history data that may complicate, in the opinion of the investigator, interpretation of the study results or create additional risk for the subject due to his/her participation in the study.
- •Unwillingness or inability of a subject to comply with the Protocol procedures (in the opinion of the investigator).
- •Pregnant or lactating women, or women planning a pregnancy.
- •Participation in another clinical study within 3 months prior to enrolment in the present study.
- •Other conditions that prevent the subject from inclusion in the study.
研究组 & 干预措施
Double-stranded RNA sodium salt
Experimental
Arm 1 (n=400) received the study drug RADAMIN®VIRO once intramuscularly, 5 mg (1 vial).
干预措施: Double-Stranded RNA sodium salt (Drug)
Placebo
Placebo Comparator
Arm 2 (n = 400) received 1 vial of placebo once intramuscularly
干预措施: Placebo (Drug)
结局指标
主要结局
Confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19
时间窗: From baseline to Visit 3 (days 10-11)
The number of subjects with confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19
次要结局
- Confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19(From baseline to Visit 2 (days 3-4), 4 (days 21 ± 1), 5 (days 28 ± 1))
- Сonfirmed COVID-19 and absence of symptoms typical for COVID-19(From baseline to Visit 2 (days 3-4), 3 (days 10-11), 4 (days 21 ± 1), 5 (days 28 ± 1))
- Duration of symptoms typical of COVID-19(From baseline to Visit 5 (study completion, day 28±1))
- COVID-19 severity evaluation(From baseline to Visit 2 (days 3-4), 3 (days 10-11), 4 (days 21 ± 1), 5 (days 28 ± 1))
- Hospitalisation due to COVID-19(From baseline to Visit 5 (study completion, day 28±1))
- Total adverse events (AEs) stratified by severity and incidence(From baseline to Visit 5 (study completion, day 28±1))
- Time to COVID-19 infection(From baseline to Visit 5 (study completion, day 28±1))
- Symptoms typical of COVID-19(From baseline to Visit 2 (days 3-4), 3 (days 10-11), 4 (days 21 ± 1), 5 (days 28 ± 1))
- Incidence of serious adverse events (SAEs), including those due to the use of the study drug/placebo.(From baseline to Visit 5 (study completion, day 28±1))
研究者
研究点 (10)
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