Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Ergoferon as Non-specific COVID-19 Prevention During Vaccination Against SARS-CoV-2
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,057
- 试验地点
- 32
- 主要终点
- The Number of Laboratory-confirmed SARS-CoV-2 Infections.
研究概览
简要总结
The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.
The objective of this study is to evaluate the efficacy and safety of Ergoferon as a non-specific preventive medicine for COVID-19 in individuals vaccinated against a new coronavirus infection (SARS-CoV-2)
详细描述
Design: the multicenter, double-blind, placebo-controlled, parallel-group, randomized trial.
The study will enroll adult participants of either gender aged ≥18 years who receive a COVID-19 vaccine. The participant signs an information sheet (Informed Consent Form) for participation in the clinical study on the day of administration of component I of the Gam-COVID-Vac (Sputnik-V) vaccine. The physician evaluates if the participant is eligible for the study. A SARS-CoV-2 rapid test (BIOCREDIT COVID-19 Ag) is carried out. If the participant tests positive for SARS-CoV-2, he/she is not enrolled in the study. The investigator's approach should be in compliance with the current version of the guidelines "Prevention, diagnosis, and treatment of a new coronavirus infection (COVID-19)" by the Ministry of Health of the Russian Federation.
If the participant meets all inclusion criteria and does not have any exclusion criteria, then he/she is included in the study, and the physician fills in source medical documentation.
Following enrollment in the study (Day 1, Visit 1), the participant is randomized into one of two groups: participants of the Group 1 receive Ergoferon in the preventive regimen for 3 weeks, and participants of the Group 2 receive Placebo in the same regimen for 3 weeks.
On the day of administration of component II of the Gam-COVID-Vac vaccine (day 22, Visit 2 + 3 days) the express test for SARS-CoV-2 (BIOCREDIT COVID-19 Ag) is performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of either gender aged ≥18 years.
- •Participant has not had COVID-19 in the previous 6 months.
- •The participant has not been vaccinated against COVID-19 or other viral infections in the previous 6 months.
- •Negative rapid test result for SARS-CoV-2 (COVID-19 Ag).
- •Absence of clinical manifestations of any infectious disease, but not earlier than 14 days from its onset.
- •Consent to use reliable contraceptive methods during the study (for men and women with reproductive potential).
- •Presence of a signed information sheet and informed consent form for participation in a clinical trial.
排除标准
- •The presence of contraindications to vaccination:
- •hypersensitivity to any component of the vaccine or a vaccine containing similar components;
- •prior history of severe allergic reactions;
- •acute infectious and non-infectious diseases, exacerbation of chronic diseases.
- •Severe chronic hepatic and renal disorders, severe thyroid dysfunction, decompensated diabetes mellitus, severe disorders of the hematopoietic system, epilepsy and other CNS diseases, acute coronary syndrome, acute cerebrovascular accident, myocarditis, endocarditis, pericarditis, autoimmune diseases, or immunodeficiency.
- •Malabsorption syndrome, including congenital or acquired lactase deficiency or any other disaccharidase deficiency, galactosemia.
- •Hypersensitivity to any of the components of study drug used in the treatment.
- •Pregnancy, breast-feeding, childbirth less than 3 months before study enrollment.
- •Participants who, from the investigator's point of view, will not comply with study observation requirements or study drug administration procedures.
- •Inability to observe the participant during the study period.
- •Prior history of mental illness, alcoholism or drug abuse, that the investigator's opinion, will interfere with successful study procedures.
- •Participation in other clinical studies within 3 months prior to enrollment in the study.
- •Use of any medications listed in "Prohibited concomitant treatment" within 4 weeks before enrollment.
- •Participants who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. "Immediate relative" means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- •Participants who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
研究组 & 干预措施
Ergoferon
Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15-30 minutes before meals), keep the tablets in the mouth, without swallowing, until completely dissolved.
干预措施: Ergoferon (Drug)
Placebo
Tablet for oral use. Placebo using Ergoferon scheme.
干预措施: Placebo (Drug)
结局指标
主要结局
The Number of Laboratory-confirmed SARS-CoV-2 Infections.
时间窗: 3 weeks
Based on medical records. The number of laboratory-confirmed SARS-CoV-2 infections (with or without symptoms) in vaccinated individuals throughout the trial. A laboratory-confirmed case will be defined as a case where the novel SARS-CoV-2 coronavirus is detected by RT-PCR in a symptomatic or asymptomatic participant with COVID-19.
次要结局
- The Percentage of Hospitalized Participants With COVID-19.(3 weeks)
- Number of Participants With Adverse Events (AEs)(3 weeks)
- Severity of AEs(3 weeks)
- Causal Relationship of AEs to the Sudy Drug(3 weeks)
- Outcome of AEs(3 weeks)