An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to clinical improvement
研究概览
简要总结
The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
详细描述
According to previous studies, IFN-β has strong antiviral activity and also has an acceptable safety profile. Based on possible therapeutic effects, We decided to lead An Investigation into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19. In a 2003 study, SARS was treated with different human interferons and found that IFN-β was 5 to 10 times more effective than other types of interferons and the strongest antiviral drug possible against SARS-CoV.
The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran.
Patients will be allocated to three therapeutic arms (Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a group and Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b group and the Base Therapeutic Regiment Group, i.e., Hydropinchloroquine + / Ritonavir. For this purpose, we will use the method of Balance Block Randomization for three groups.
After completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID-19 Confirmed Cases By Means of RT-PCR
- •Oxygen saturation (SPO2) ≤ 93% OR respiratory rate ≥ 24
- •At least one of the following: Calibrated contactless infrared forehead thermometry temperature of ≥37.8, cough, sputum production, nasal discharge, myalgia, headache or fatigue on admission.
- •Time of onset of the symptoms should be acute ( Days ≤ 14)
排除标准
- •Refusal to participate expressed by patient or legally authorized representative if they are present
- •Patients with prolonged QT or PR intervals, Second or Third Degree heart block, Arrhythmias including torsade de pointes
- •Patients using drugs with potential interaction with Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a، Interferon-β 1b.
- •Pregnant or lactating women.
- •History of alcohol or drug addiction in the past 5 years.
- •Blood ALT/AST levels > 5 times the upper limit of normal on laboratory results.
研究组 & 干预措施
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b
干预措施: Hydroxychloroquine (Drug)
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a
干预措施: Hydroxychloroquine (Drug)
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a
干预措施: Lopinavir / Ritonavir (Drug)
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a
干预措施: Interferon Beta-1A (Drug)
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b
干预措施: Lopinavir / Ritonavir (Drug)
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b
干预措施: Interferon Beta-1B (Drug)
Control group: hydroxychloroquine + Lopinavir / Ritonavir
干预措施: Hydroxychloroquine (Drug)
Control group: hydroxychloroquine + Lopinavir / Ritonavir
干预措施: Lopinavir / Ritonavir (Drug)
结局指标
主要结局
Time to clinical improvement
时间窗: From date of randomization until 14 days later.
Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R\&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.
次要结局
- Incidence of new mechanical ventilation use(From date of randomization until 14 days later.)
- Duration of hospitalization(From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.)
- Mortality(From date of randomization until 14 days later.)
- SpO2 Improvement(Days 1, 2, 3, 4, 5, 6, 7 and 14.)
研究者
Seyed Sina Naghibi Irvani, MD, MPH, MBA, Senior Researcher.
Dr.
Shahid Beheshti University of Medical Sciences