An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug for the Prevention and Treatment of Symptoms of Pulmonary Complications in Patients With Coronavirus Infection (SARS-COVID-19)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Duration of hospitalization
研究概览
简要总结
The purpose of the study is to evaluate an effectiveness of the drug Dalargin in combination with Leitragin for the prevention and treatment of severe pulmonary complications symptoms associated with severe and critical coronavirus infection cases (SARS COVID19, expanded as Severe acute respiratory syndrome Cоrona Virus Disease 2019 ).
Test drugs that will be administered to patients are:
- Leitragin, solution for inhalation administration,
- Dalargin, solution for intravenous and intramuscular administration.
详细描述
Research objectives are:
- To study the effectiveness of the drug Leitragin, a solution for inhalation, for the prevention of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
- To study the effectiveness of the drug Leitragin, a solution for inhalation, for the treatment of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
- To study the effectiveness of the drug Dalargin, a solution for intravenous and intramuscular administration, for the prevention of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
- To study the effectiveness of the drug Dalargin, a solution for intravenous and intramuscular administration, for the treatment of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
- To evaluate the safety and tolerability of the use of the drug Leitragin, a solution for inhalation administration, for the prevention of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
- To evaluate the safety and tolerability of the use of the drug Leitragin, a solution for inhalation administration, for the treatment of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
- To evaluate the safety and tolerability of the use of the drug Dalargin, a solution for intravenous and intramuscular administration, for the prevention of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
- To evaluate the safety and tolerability of the use of the drug Dalargin, a solution for intravenous and intramuscular administration, for the treatment of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19).
Upon admission to a specialized hospital for all patients with suspected COVID-19 Polymerase chain reaction (PCR) is being conducted. Only patients with confirmed coronavirus infection are included in the study.
It is an open, randomized clinical trial of the drug Dalargin in combination with Leitragin for the prevention and treatment of severe pulmonary complications symptoms in patients with coronavirus infection (SARS-COVID-19)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients from the age of 18 years male and female;
- •Coronavirus infection confirmed by results of Polymerase chain reaction test;
- •Hospitalization of the patient;
- •The presence of a signed informed consent to participate in the study.
排除标准
- •Revocation of informed consent by the patient.
- •Patient mismatch inclusion criteria.
- •First identified conditions and / or diseases described in the non-inclusion criteria.
- •The criteria for early termination of patient participation in the study during the period of use of the study drug are:
- •Patient withdrawal of informed consent.
- •First identified conditions and / or diseases described in the non-inclusion criteria.
- •The occurrence of serious adverse events.
- •Adverse events that do not meet the criteria of severity, the development of which, according to the researcher, further participation in the study may be detrimental to the health or well-being of the patient.
- •Administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as gross protocol violations that may affect the results of the study.
- •The patient receives / needs additional treatment that may affect the outcome of the study or patient safety
- •Individual intolerance to research drugs
- •Incorrect inclusion (for example, the patient was included in violation of the criteria for inclusion / non-inclusion of the protocol)
结局指标
主要结局
Duration of hospitalization
时间窗: up to 10 days
The number of days a patient is hospitalized
The change of viral load in patients with SARS-COVID-19.
时间窗: Upon patient inclusion in the study, after 96 hours and on the 10day;
Estimated by Polymerase chain reaction (PCR)
Clinical status at the time of completion of participation in the study
时间窗: an average of 10 days
Clinical status at the time of completion of participation in the study will be estimated based upon the following criteria: 1. Death; 2. Hospitalization is extended, on invasive mechanical ventilation of the lungs with extracorporeal membrane oxygenation; 3. Hospitalization extended, on non-invasive ventilation; 4. Hospitalization is extended, needs additional oxygen; 5. Hospitalization is extended, additional oxygen is not required; 6. Discharged.
The frequency of development of Acute Respiratory Distress Syndrome (ADRS)
时间窗: up to 10 days
Assessed through the entire patient participation in the study
The frequency of early mortality
时间窗: up to 30 days
Early mortality from all causes will be estimated
The frequency of late mortality
时间窗: up to 90 days
Late mortality from all causes will be estimated
次要结局
未报告次要终点
研究者
Tatyana Astrelina
MD PhD, DSc (medicine), Head of Center for Biomedical Technologies State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia
Burnasyan Federal Medical Biophysical Center