跳至主要内容
临床试验/NCT04331470
NCT04331470Unknown2 期

Evaluation of Efficacy of Pharmacotherapy Treatment of COVID- 19 Infection Using Oral Levamisole and Formoterol+Budesonide Inhaler and Comparison of This Treatment Protocol With Standard National Treatment of the Disease

Fasa University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年4月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
30
试验地点
1
主要终点
Clear chest CT-scan

研究概览

简要总结

New Corona virus (COVID-19) has made a horrible situation for all of the countries. This disease is not only a health problem but also economy, culture and the whole entity of the countries is under attack by the virus. This disease seems to affect the body in two different pathology pathways. From one side virus can decrease activity of immune system in the blood stream and whole body and from other side it can attack the respiratory cells. Tissue biopsy shows that immune cells penetrate into the Lung tissue and we have accumulation and over activity of Immune cells in the lung. This inflammation in respiratory tract probably is the major cause of Cytokine storm and release of TNF-α and IL-6 into the blood.

It seems that by three strategy disease can be treated. 1- By using systemic immune simulators. 2- By using topical anti-inflammatory drug in the respiratory system (Steroids or NSAIDs) 3- By inhibition of replication of the virus in the attacked cells.

详细描述

Looking at the pathology of this disease shows that COVID-19 virus binds to the Angiotensin converting enzyme II (ACE II) which is located on the surface of different cells in the body and specially on the cells of respiratory system. This enzyme is responsible to turn angiotensin II into angiotensin1-7. It is also turns angiotensin I into angiotensin 1-9.

When ACEII would be blocked by virus level of angiotensin II will be increased and this enzyme along with vasoconstriction, makes cells to manufacture TNF α and IL-6 which are responsible for cytokine storm and Lymphopenia. Also presence of virus and virus shell on the surface of the infected cells make immune system to attack to the respiratory system hence effect of angiotensin II inside the cell causes fibrosis of the respiratory cells. This inflammation and tissue damage make Acute Respiratory Distress syndrome (ARDS) which is lethal for patients. There is a dilemma in treatment of this infection. From one side it doesn't make sense to decrease the immune response hence it will make the infection worse. And from other side stimulation of the immune response because of respiratory inflammation can expedite process of lethal ARDS. A new strategy for treatment of this disease which consists of local anti- inflammatory and systemic immune stimulant drugs can be considered as a reasonable strategy.As immunostimulator, Levamisole can increase Lymphocytes and empower the immunity of the body. This drug can also bind to Papaine Like Protease(PL-pro) of the shell of the virus which is necessary for virulence of COVID-19. It also can decrease level of TNF α and IL-6, and as a chemical adjutant can introduce the virus to the immune system. In addition to Levamisole, Formoterol+Budesonide inhaler can be used in this protocol. Budesonide is a steroid and can suppress the immune reaction locally in the respiratory system. Formoterol is β2 agonist and can open airways. It also can bind to PL-pro and can neutralize the virus according to the published articles.

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, Outcomes Assessor)

盲法说明

All of the research team will be blind about the groups of study and position of patients in each group except of physician and main researcher. Files of patients which will be numbered using a random number table will be sent for analyzer of the study.Information about position of patients in the groups is masked from research team. Outcomes Assessor will receive the information of patients without any name in the file. Just when statistical analysis would be finished information of groups will be revealed.

入排标准

年龄范围
15 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Definitely positive COVID-19 patients

排除标准

  • Patients with acute respiratory problems including patients with:
  • Severe respiratory distress
  • Heamodynamic instabilitty
  • Acid base disturbance
  • Severe Anemia Patients with severe hepatic diseases Patients with Nurvous system diseases

研究组 & 干预措施

Levamisole Pill + Budesonide+Formoterol inhaler+Standard care

Experimental

This group will take Levamisole + Budesonide/Formoterol along side with standard treatment regime.

干预措施: Levamisole Pill + Budesonide+Formoterol inhaler (Drug)

Levamisole Pill + Budesonide+Formoterol inhaler+Standard care

Experimental

This group will take Levamisole + Budesonide/Formoterol along side with standard treatment regime.

干预措施: Lopinavir/Ritonavir + hydoxychloroquine (Drug)

Standard care

Active Comparator

This group will take standard treatment regime introduced by Ministry of health.

干预措施: Lopinavir/Ritonavir + hydoxychloroquine (Drug)

结局指标

主要结局

Clear chest CT-scan

时间窗: between 3-7 days

Chest Ct scan should be negative

PCR test

时间窗: between 3-7 days

PCR test should be negative

次要结局

  • Physical statues of patient(Between 3-7 days)

研究者

发起方
Fasa University of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Siamack Afazeli

Doctor

Fasa University of Medical Sciences

研究点 (1)

Loading locations...

相似试验

Evaluation of Efficacy of Levamisole and... | 临床试验