NCT05185804已完成3 期
Multicenter Randomized Prospective Open-label Clinical Trial of the Safety and Efficacy of Amidine Hydrochloride (DD217) in Prevention of Thrombotic Complications in Hospitalized Patients Diagnosed With COVID-19
PharmaDiall Ltd.6 个研究点 分布在 1 个国家目标入组 399 人开始时间: 2021年2月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 399
- 试验地点
- 6
- 主要终点
- The frequency of DVT
研究概览
简要总结
Study purpose was to study the safety and efficacy of Dimolegin - DD217 as a drug for prevention of thrombotic complications compared to Clexane (enoxaparin sodium) - the standard therapy currently prescribed to patients hospitalized with COVID-19.
Patients who met all inclusion criteria and no exclusion criteria were randomized into two therapy groups:
- Group 1 - test drug Dimolegin - DD217 (60 mg orally, 1 time per day);
- Group 2 - reference drug Clexane (40 mg subcutaneously, 1 time per day).
The study drugs were taken once a day until:
- the discharge from the hospital due to recovery or positive dynamics;
- or up to 30 days of the patient's stay in the hospital;
- or until the Investigator decides to discontinue the therapy for other reasons. Planned: screening of up to 450 patients, randomization: 430 (215 per group). The required number of patients is 200 per group as a result of the entire study.
详细描述
Study purpose:
To study the safety and efficacy of Dimolegin - DD217 as a drug for prevention of thrombotic complications compared to Clexane (enoxaparin sodium) - the standard therapy currently prescribed to patients hospitalized with COVID-19.
Study objectives:
- To study the clinical efficacy of Dimolegin - DD217 as a drug for prevention of thrombotic complications in patients hospitalized with COVID-19.
- To assess the proportion of patients with the development of thrombotic complications: deep vein thrombosis (DVT), pulmonary embolism (PE), ischemic stroke, acute mycardial infarction (AMI), arterial thrombotic complications of other localizations (thrombosis of mesenteric arteries, renal arteries, spleen, upper and lower extremities) during the study therapy (maximum - 30 days).
- To evaluate the proportion of patients transferred to the ICU due to complications of COVID-19 and the all-cause mortality rate during the study therapy (maximum - 30 days) and during the study (maximum 90± 2 days); To study the safety of use, the rate of major and clinically significant minor bleeding and possible side effects of Dimolegin - DD217 during the study therapy (maximum - 30 days).
Methodology:
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have signed a written consent to participate in the study
- •Hospitalized patients with a diagnosis: COVID-19 coronavirus disease confirmed by laboratory testing regardless of the severity of clinical signs no later than 72 hours before screening (U07.1 - virus was identified), or COVID-19 coronavirus disease, when the infection is diagnosed clinically or epidemiologically no later than 72 hours before screening, but laboratory tests are inconclusive or unavailable (U07.2 - virus was not identified), moderate form. To be classified as a moderate form, the patient must have at least one of the following criteria: Body temperature > 38 °C; respiratory rate (RR) > 22/min; shortness of breath during physical exertion; CT (radiography) findings typical of viral lesion (minimal or average lesion volume, Grade 1-2 on CT); SpO2<95 %; serum C reactive protein (CRP) > 10 mg/L
- •Males and non-pregnant females (negative pregnancy test or human chorionic gonadotropin (HCG) blood test (for females with childbearing potential)) at the age of 18 to 85 years
- •Patients who are able to comply with all the requirements of the study protocol;
- •Patients who agreed to use adequate methods of contraception during the entire study and for at least 7 days after the end of the study
排除标准
- •Patients treated with anticoagulants or fibrinolytics before inclusion in the study (for example, treatment of venous thromboembolism, atrial fibrillation, the presence of a mechanical prosthetic heart valve, etc.)
- •The need to prescribe anticoagulants to the patient at therapeutic doses
- •Active bleeding currently or within 6 months prior to screening, high risk of bleeding
- •Severe anemia
- •Severe thrombocytopenia
- •Congenital thrombophilia (deficiency of antithrombin III, protein C, protein S, Leiden mutation of coagulation factor V, increased level of coagulation factor VIII, mutation of prothrombin G20210A, etc.)
- •Other coagulation disorders and indications when anticoagulants is impossible to use according to the Investigator
- •It is necessary to monitor and to treat in the ICU
- •Disease with the life expectancy of <3 months
- •Surgery on the brain or spinal cord, spine, ophthalmic or major surgery or injury in the last 90 days
- •Gastrointestinal tract disorders that can disrupt the absorption of the study drug (Crohn's disease, ulcerative colitis, irritable bowel syndrome, etc.)
- •Acute gastric or duodenal ulcer, erosive gastritis with increased risk of bleeding
- •Active liver disease (viral hepatitis B or C, cirrhosis of the liver) and biliary tract disease, with the exception of non-alcoholic steatohepatitis with normal levels of hepatic transaminases
- •Nephrotic syndrome, significant kidney diseases with the nephrotic syndrome events
- •Severe renal failure (creatinine clearance < 30 mL/min)
- •Active cancer (excluding non-melanoma skin cancer), defined as cancer without remission or requiring active chemotherapy or additional treatments such as immunotherapy or radiation therapy
- •History of HIV, lues
- •History of tuberculosis
- •Significant drug or alcohol abuse according to the Investigator in the history or currently
- •The development of trophic disorders on the lower extremities that do not respond to medical treatment
- •The blood level of platelets is below 25•109L
- •Body mass index (BMI) less than 18.5 or more than 40 kg/m
- •Body weight below 40 kg or above 130 kg
- •Systolic blood pressure (SBP) > 180 mmHg and/or diastolic blood pressure (DBP) >110 mmHg and/or SBP < 90 mmHg and/or DBP <60 mmHg
- •Hypersensitivity or contraindications to DD217 or enoxaparin sodium
- •Women who are pregnant or breastfeeding
- •Women planning pregnancy during a clinical trial (including women who received a positive pregnancy test result at screening or before taking the study drug);
- •Women of childbearing potential (including non-sterilized surgically and in the postmenopausal period less than 2 years) who do not want or cannot use adequate methods of contraception throughout the study. Adequate methods of contraception include the use of a condom or diaphragm (barrier method) with spermicide
- •Participation in another clinical trial currently or within 30 days prior to screening, use of any study drug for 30 days or 5 half-lives (which is longer) prior to screening
- •Inability to read or write; unwillingness to understand and follow the procedures of Study Protocol
- •Failure to comply with the regimen of treatment or procedures, which, in the opinion of the Investigator, may affect the study results or the safety of the patient and prevent the patient from further participating in the study
- •Any other concomitant medical or serious mental conditions that make the patient ineligible for a clinical trial, limit the validity of the informed consent, or may affect the patient's ability to participate in the study
研究组 & 干预措施
Group DD217
Experimental
Study drug Dimolegin - DD217, 60 mg orally, 1 time per day
干预措施: Dimolegin (Drug)
Group Clexane
Active Comparator
Reference drug Clexane, 40 mg subcutaneously, 1 time per day
干预措施: Clexane (Drug)
结局指标
主要结局
The frequency of DVT
时间窗: 30 Days
The frequency of DVT during the study therapy (maximum - 30 days)
The frequency of PE
时间窗: 30 Days
The frequency of PE during the study therapy (maximum - 30 days)
The frequency of ischemic stroke
时间窗: 30 Days
The frequency of ischemic stroke during the study therapy (maximum - 30 days)
The frequency of AMI
时间窗: 30 Days
The frequency of AMI during the study therapy (maximum - 30 days)
The frequency of arterial thrombotic complication
时间窗: 30 Days
The frequency of arterial thrombotic complication (thrombosis of mesenteric arteries, renal arteries, spleen, upper and lower extremities) during the study therapy (maximum - 30 days)
次要结局
- The proportion of patients who stayed in the hospital more than 30 days(30 Days)
- The all-cause mortality rate(30 Days)
- The number of days the patient spent in the hospital before discharge due to recovery or positive dynamics, including outpatient follow-up before 30 days expire(30 Days)
- The proportion of patients transferred to the ICU(30 Days)
- The all-cause mortality rate during the study(90 Days)
- Proportion of patients requiring high-flow oxygen therapy or noninvasive ventilation (NIV)(30 Days)
- Changes in the hemostasis system parameters(30 Days)
- The efficacy of drugs in patients depends on the D-dimer level at screening(30 Days)
- Recovery rate(30 Days)
研究者
研究点 (6)
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