Open Multicenter Controlled Clinical Trial to Evaluate Safety and Efficacy of Aerosolized MIR 19 ® Inhalation in Adult Outpatients With Mild COVID-19.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 984
- 试验地点
- 1
- 主要终点
- Moderate or severe COVID-19
研究概览
简要总结
The aim of this study is to evaluate the effectiveness and safety of MIR 19 ® in preventing development of moderate and/or severe course of the disease in mild COVID-19 outpatients.
Primary endpoint:
The proportion of patients with the development of moderate or severe COVID-19 disease (in accordance with the criteria specified in the Interim Guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)" by the Ministry of Health of the Russian Federation, version 14 of 27.12.2021 or current at the time of the study) by the 28th day of observation.
详细描述
This is Phase 2b-3 multi-center controlled randomized study to assess the efficacy and safety of MIR 19 ® via 7 days treatment in a dose of 5.55 mg/day of participants with symptomatic mild COVID-19 who did not require hospitalisation.
The MIR 19® is a complex of siRNA, targeting Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) RNA-dependent RNA polymerase (RdRp) and peptide dendrimer (KK-46).
This study involved 2 cohorts who received:
- 5.5 mg of the MIR 19 ® per day via inhalation route plus standard therapy which included symptomatic treatment, without any etiotropic drugs.
- Standard therapy which included symptomatic treatment as well as etiotropic drugs except MIR 19 ®.
All subjects will undergo scheduled safety and efficacy assessments as outpatients to the end of the follow-up period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over the age of 18 who have been diagnosed with COVID-19 and who need therapy on an outpatient basis according to the Interim Guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)"by Ministry of Health of the Russian Federation. Version 14 from 12/27/
- •Able to give informed consent and attend all study visits
- •Duration of the disease from the first symptoms (presence of at least one of the following symptoms: fever, cough, myalgia, weakness, shortness of breath, headache, nausea, stool disorders, loss of appetite) up to the day of screening no more than 5 days.
- •Negative pregnancy test for women with preserved reproductive potential
- •Participants must agree to use the reliable contraception while on study medication and for posttrial contraception for 3 month
- •The patient's ability to inhale the experimental drug
排除标准
- •Respiratory rate is more than 22 / min
- •Oxygen saturation - SpO2 ≤ 94%.
- •Decreased level of consciousness, agitation.
- •Unstable hemodynamics (systolic blood pressure less than 100 mmHg or diastolic blood pressure less than 60 mmHg).
- •Long-term systemic corticosteroid exposure.
- •Autoimmune or inflammatory diseases (systemic / localized), as well as oncological diseases.
- •Symptoms of moderate, severe or critical COVID-19 at the time of screening
- •Positive blood tests for HIV, hepatitis B and С, syphilis.
- •Pregnancy and breast-feeding.
- •Previous adverse reactions to the active substance and/or excipients included in the drug
- •Chronic diseases of the cardiovascular system
- •Type 1 diabetes.
- •The following laboratory parameters are excluded: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total and direct bilirubin >4 x upper limit of normal (ULN);
- •C-reactive protein (CRP) level > 10 mg/L.
- •Participation in other investigational drug or device clinical trials within 90 days prior to screening.
- •History of alcohol, drug or chemical abuse
- •Previous hospitalizations associated with the development of moderate and severe COVID-
- •Mental illness.
- •Receipt of plasma from a person who recovered from COVID-19 (convalescent plasma) up to 14 days before participating in the study, vaccination against SARS-CoV-2 less than 4 weeks before randomization.
- •Any conditions that, according to the researcher's, may be a contraindication to the participation in the study.
研究组 & 干预措施
MIR 19 ®
MIR 19 ® was used in a single dose of 1.85 mg for 3 inhalations per day at intervals of 6-7 hours for 7 days in addition to standard therapy without use of any etiotropic drugs.
Standard therapy included:
- paracetamol - 1-2 tablets (500-1000 mg) 2-3 times a day (if body temperature ≥38.0°)
干预措施: MIR 19 ® (Drug)
Standard therapy
Standard therapy included:
- umifenovir (Arbidol®) - 200 mg 4 times per day for 7 days
- interferon-α, intranasal forms (Grippferon®),spray - in accordance with the instructions.
- paracetamol - 1-2 tablets (500-1000 mg) 2-3 times a day (if body temperature ≥38.0°)
干预措施: Standard therapy (Combination Product)
结局指标
主要结局
Moderate or severe COVID-19
时间窗: 28th day of observation
The proportion of patients with the development of moderate or severe COVID-19 disease (in accordance with the criteria specified in the Interim Guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)" by the Ministry of Health of the Russian Federation, version 14 of 27.12.2021 or current at the time of the study)
次要结局
- Etiotropic therapy(28th day of observation)
- Severity of COVID-19 symptoms(28th day of observation)
- Results of polymerase chain reaction (PCR)(28th day of observation)
- Improvement / disappearance of COVID-19 symptoms(28th day of observation)
- Duration of COVID-19 symptoms(28th day of observation)
- Moderate COVID-19(28th day of observation)
- Severe COVID-19(28th day of observation)
- Critical COVID-19(28th day of observation)
- Hospitalization(28th day of observation)
- Death rate(28th day of observation)
- Worsening of COVID-19 symptoms(28th day of observation)