NCT05656495已完成3 期
An Open Randomized Multicenter Comparative Study to Evaluate the Efficacy, Safety and Tolerability of the Use of Ambervin® for Intramuscular Administration and for Inhalation in Patients Hospitalized With COVID-19
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
- 313
- 试验地点
- 10
- 主要终点
- Prevalence of patients with category 0-1 as per categorical ordinal clinical improvement WHO scale
研究概览
简要总结
This is open-labe randomized multicenter comparative Phase III study conducted in 8 medical facilities. The objective of the study is to assess the efficacy, safety and tolerability of Ambervin for intramuscular and inhaled administration in complex therapy COVID-19 compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19.
详细描述
Upon signing the informed consent form and screening, 313 eligible patients hospitalized with COVID-19 were randomized at a 1:1:1 ratio to receive either Ambervin intramuscular 1mg 1 times a day for 10 days or Ambervin inhaled 10mg 1 times a day for 10 days or SOC.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Availability of the Informed Consent Form of thePatient Information Leaflet (PIL) signed and dated bypatient.
- •Men and women aged 18 to 80 years inclusive at thetime of signing the Informed Consent Form in PIL.
- •Confirmed case of COVID-19 at the time ofscreening based on SARS-CoV-2 RNA test usingnucleic acid amplification (NAA) method. It isacceptable to include a patient with a presumptiveCOVID-19 diagnosis prior to receiving the results ofSARS-CoV-2 RNA test made at the screening stage.
- •Hospital admission due to COVID-
- •Moderate severity infection with SARS-CoV-2: Clinical signs (the presence of at least 2 of the following criteria):
- •body temperature > 38 °C;
- •RR > 22/min;
- •CT pattern typical of a viral lesion
- •shortness of breath on exertion;
- •SpO2 < 95%;
- •Serum CRP > 10 mg/L.
- •Lesion volume is minimal or moderate; CT 1-
- •Patient's consent to use reliable contraceptive methods through out the study and within 1 month for women and 3 months for men after its completion. Reliable means of contraception are: sexualabstinence, use of condom in combination withspermicide.
- •Women incapable of childbearing may also participate inthe study (with past history of: hysterectomy, tubal ligation,infertility, menopause for more than 2 years), as well asmen with infertility or a history of vasectomy
排除标准
- •Hypersensitivity to components of the study drug.
- •Impossibility of CT procedure (for example, gypsumdressing or metal structures in the field of imaging).
- •Obstacles or inability to perform intramuscular injections and / or inhalations
- •Arterial hypotension (a decrease in blood pressure (BP) below 100/60 mm Hg) at the time of screening and / or a history of hypotensive crises.
- •The need for the use of drugs from the list of prohibited therapies.
- •Availability of criteria for severe and extremely severe disease at the time of screening
- •Presence within 6 months prior to screening of a probable or confirmed case of moderate COVID-19
- •History of presumptive or confirmed COVID-19 caseof moderate, severe and extremely severe course ofthe disease.
- •Vaccination less than 4 weeks prior to screening.
- •The need for treatment in the intensive care unit at the time of screening.
- •Impaired liver function (AST and/or ALT ≥ 2 UNLand/or total bilirubin ≥ 1.5 UNL) at the time ofscreening.
- •Renal impairment (GFR < 60 ml/min) at the time of screening.
- •Positive testing for HIV, syphilis, hepatitis B and/or C.
- •Chronic heart failure FC III-IV according to New York Heart Association (NYHA) functional classification.
- •Malignancies in the past medical history.
- •Alcohol, pharmacological and/or drug addiction in the past medical history and/or at the time of screening.
- •Epilepsy in history.
- •Schizophrenia, schizoaffective disorder, bipolardisorder, or other history of mental pathology orsuspicion of their presence at the time of screening.
- •Severe, decompensated or unstable somatic diseases (any disease or condition that threaten thepatient's life or impair the patient's prognosis, and also make it impossible for him/her to participate in the clinical study).
- •Any history data that the investigating physician believes could lead to complication in the interpretation of the study results or create an additional risk to the patient as a result of his/her participation in the study.
- •Patient's unwillingness or inability to comply with procedures of the Study Protocol (in the opinion of physician investigator).
- •Pregnant or nursing women or women planning pregnancy.
- •Participation in another clinical study for 3 monthsprior to inclusion in the study.
- •Other conditions that, according to the physicianinvestigator, prevent the patient from being includedin the study.
研究组 & 干预措施
Ambervin intramuscularly
Experimental
Arm 1 (n=104) receives the study drug Ambervin for intramuscularly administration 1 mg 1 time per day. The course of treatment is 10 days.
干预措施: Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate intramuscularly (Drug)
Ambervin inhaled
Experimental
Arm 2 (n=105) receives the study drug Ambervin for inhalation administration 10 mg 1 time per day. The course of treatment is 10 days.
干预措施: Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate inhaled (Drug)
Standard of care
Active Comparator
Arm 3 (n=104) patients receive standard therapy prescribed in accordance with the recommended treatment regimens included in the InterimGuidelines for the prevention, diagnosis and treatment of new coronavirus infection (COVID-19) approved by the Russian Ministry of Health by decision of the investigator and taking into account the availability of drugs at the study site
干预措施: Standard of care (Drug)
结局指标
主要结局
Prevalence of patients with category 0-1 as per categorical ordinal clinical improvement WHO scale
时间窗: From baseline to Visit 4 (days 14-15)
The proportion of patients with category 0-1 as per the categorical ordinal clinical improvement scale
次要结局
- Prevalence of patients with clinical status less than 4 points on the categorical ordinal WHO scale of clinical improvement(From baseline to Visit 3 (days 11-12) and 4 (days 14-15))
- Frequency of improvement in clinical status on a categorical ordinal WHO scale of clinical improvement of 2 or more categories(From baseline to Visit 3 (days 11-12) and 4 (days 14-15))
- Time to improve clinical status on a categorical ordinal scale of clinical improvement by ≥ 1 point.(From baseline to Visit 6 (study completion, day 28±1))
- Prevalence of patients eligible for discharge to continue outpatient treatment according to BMR(From baseline to Visit 2 (days 6-7), 3 (days 11-12))
- Prevalence of patients with RR < 22/min(From baseline to Visit 2 (days 6-7), 3 (days 11-12))
- Prevalence of patients with CRP level < 10 mg/l(From baseline to Visit 2 (days 6-7), 3 (days 11-12))
- Prevalence of patients with blood lymphocytes > 1.2 x 10(9)/L(From baseline to Visit 2 (days 6-7), 3 (days 11-12))
- Assessment of the degree of lung damage according to CT(From baseline to Visit 4 (days 14-15))
- Prevalence of patients with SpO2 ≥ 95% on 2 consecutive days(From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15))
- The frequency of transfer of patients to the intensive care unit and intensive care(From baseline to Visit 6 (study completion, day 28±1))
- The frequency of cases of the use of high flow oxygen therapy, non-invasive and invasive ventilation of lung, ECMO(From baseline to Visit 6 (study completion, day 28±1))
- The frequency of cases of ARDS(From baseline to Visit 6 (study completion, day 28±1))
- The frequency of patients with a fatal outcome(From baseline to Visit 6 (study completion, day 28±1))
研究者
研究点 (10)
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