A Comparative, Multicenter, Placebo-Controlled, Double-Blind Phase II Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Inhaled Aviptadil in Patients 18 Years and Older With COVID-19 Pulmonary Involvement - HOPE
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 9
- 主要终点
- Clinical improvement
研究概览
简要总结
This study is a multicenter, prospective, placebo-controlled, comparative, randomized, double-blind local phase II clinical trial. Duration of study is 18 months. In the study, patients will be randomized in a ratio of 1: 1 into two arms, standard medical therapy + placebo versus standard medical therapy + inhaled Aviptadil arms. Randomization will be carried out by the block randomization method. In the event that patients need intensive care in the study, the patients will be taken into intensive care unit and excluded from the study and their treatment will be continued in the intensive care unit as deemed appropriate by the physician and it is foreseen that inhaled Aviptadil will be used for a period of minimum 7 and maximum 14 days. Aviptadil will be discontinued in patients who do not heal after 14 days. This study includes 8 visits, consisting of a total of 7 physical visits and 1 phone follow-up visit. The study period will be 6 months for each patient. Patient recruitment is planned to take 12 months. Study centers will be asked to use investigational products for their patients who sign the informed consent form for 12 months. The study population will consist of patients 18 years of age and older with COVID-19 pulmonary involvement and hospitalized patients.
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
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18 years and older women or men, under 70 years old
- •2.Patients with positive SARS-CoV-2 real time PCR result and an appearance in line with COVID-19 pneumonia on thorax CT
- •Need for oxygen support or SpO2 <94 in room air
- •Patients who can use a nebulizer (with assistance when necessary)
- •5.Patients who are willing and capable (mentally and physically) who can sign a written informed consent form, to participate in all aspects of the study, to participate in the planned visits and to comply with the terms of the protocol.
排除标准
- •Intensive care admission
- •The need for mechanical ventilation
- •Patients with previously known organ (kidney, heart and liver) failure
- •* To be determined as previously known heart failure (EF <30), previously known liver failure (Child-Pugh C) and previously known renal failure (Cr.clerance <30).
- •COVID-19 disease with no indication for hospitalization
- •Participants in another clinical trial
- •Pregnancy or lactation
- •Solid organ or stem cell transplantation story
- •Patients with collagen tissue disease
- •Use of immunosuppressive therapy
- •Procalcitonin ≥2 (baseline visit)
- •Under 18 years old
- •Those who had myocardial infarction in the last 3 months
- •Those who do not have the capacity to understand the possible results, scope and nature of the study due to legal insufficiency and / or other reasons.
- •Those who, in the opinion of the investigator, cannot continue the treatment protocol regularly or cannot cooperate
- •Presence of malignancy
- •Patients with neurological diseases
研究组 & 干预措施
Standard Treatment + Placebo
Standard medical treatment, as deemed appropriate by physicians, is going to be according to the Turkish Republic COVID-19 (SARS-CoV-2 INFECTION) ADULT PATIENT TREATMENT GUIDELINES published by the Ministry of Health, General Directorate of Public Health. The management of all additional complications and / or symptoms that develop in patients will be managed in the same way as specified in these guidelines. If these guidelines are changed by the Turkish Republic Ministry of Health General Directorate of Public Health, a protocol amendment will be planned. The necessary changes within the scope of urgent security measures will be reflected in the standard treatment in accordance with the necessary regulations.
干预措施: Placebo (Drug)
Standard Treatment + Inhaled Aviptadil
In addition to the standard medical treatment mentioned above, patients randomized to this arm will be given Inhaled Aviptadil 2 times a day, 30 minutes apart. Aviptadil treatment is aimed to be a minimum of 7 days and a maximum of 14 days. Aviptadil will be discontinued in patients who do not heal after 14 days. The dose of inhaled Aviptadil was determined by evaluating the results of the Phase 1 and Phase 2 studies.
干预措施: Inhaled Aviptadil (Drug)
结局指标
主要结局
Clinical improvement
时间窗: 6 months
Being discharged within 30 days of starting treatment, no need for oxygen support
次要结局
- Normalization in Respiration Rate/Minute(14 days)
- Time to discharge of patients(6 months)
- Change in SpO2 (measured by pulse oximetry)(6 months)
- The time it takes for the PCR to become negative(14 days)
- Sequelae and recovery rates in control thorax computed tomography at the end of month 1 and 6 months(6 months)
- Need for re-hospitalization(6 months)
- The rate of patients entering intensive care(6 months)
- Patients' rate of needing mechanical ventilation(6 months)
- Normalization in body temperature(14 days)
- Normalization in laboratory results of blood parameters (PT, aPTT, D-dimer, Ferritin, Lymphocyte Count, CRP)(28 days)
- Normalization in laboratory results of biochemistry parameters (Glucose, ALT, AST, LDH, Total Bilirubin, Total Protein, Albumin, Alkaline Phosphatase, GGT, Sodium, Potassium, Calcium, Phosphor, CPK, Magnesium, eGFR, BUN, Uric Acid, Creatinine Clearance)(28 days)
- Mortality rate(6 months)
- Normalization in Blood Pressure(14 days)
- Dyspnea Scale (Modified Borg Dyspnea Scale (MBS)(6 months)
- 6-minute walking test(28 days)
- The time it takes for patients to improvement of their symptoms (cough, shortness of breath)(6 months)
- Normalization in SpO2(14 days)