An Open-label Randomised Controlled Trial on IFN Beta-1b and Ribavirin Combination, as Treatment for Covid-19 Infection
试验速览
- 阶段
- 2 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Clinical symptoms alleviation
研究概览
简要总结
As of 1 July 2020, more than 10 million people been confirmed to have infected by SARS-CoV-2, resulting in more than 500,000 deaths. No specific antiviral treatment for the SARS-CoV-2 is currently available, but existing medication could be repurposed.
The investigators therefore propose to conduct an open-label randomized controlled trial on a short course of interferon β-1b and ribavirin combination treatment for patients hospitalized for COVID-19 infection.
详细描述
The novel coronavirus (SARS-CoV-2), is a single-stranded RNA coronavirus. The virus was first isolated from patients presented with pneumonia in Wuhan in December 2019. It is believed that the virus first emerged from patients working in the Wuhan Seafood Market which also sold contaminated wild animals, consumed as a local delicacy. Sequences of the Wuhan betacoronavirus show similarities to betacoronaviruses found in bats, sharing a common ancestor with the 2003 SARS coronavirus (SARS-CoV).
The SARS-CoV-2 has since spread from China to the rest of the world. As of 1 July 2020, more than 10 million people been confirmed to have infected by SARS-CoV-2, resulting in more than 500,000 deaths. No specific antiviral treatment for the SARS-CoV-2 is currently available, but existing medication could be repurposed.
Previously, the investigators have demonstrated that interferon beta-1b, commonly used in the treatment of multiple sclerosis and lopinavir/ ritonavir, also demonstrated to improve the outcome of MERS-CoV infection in a non-human primate model of common marmoset. More recently, the investigators have demonstrated that the triple combination of interferon β-1b, lopinavir/ ritonavir and ribavirin was significantly more effective in alleviating symptoms and respiratory SARS-CoV-2 viral load than lopinavir/ ritonavir with ribavirin or lopinavir/ ritonavir alone, suggesting that interferon β-1b might be the most potent antiviral among the three and lopinavir/ ritonavir is associated with relatively more side effects including diarrhoea and cardiac arrhythmia.
Therefore, the investigators propose to conduct an open-label randomized controlled trial on a short course of interferon β-1b and ribavirin combination treatment for patients hospitalized for COVID-19 infection.
Patients will be randomly assigned to one of the two groups: the Treatment group: a 5-day course of subcutaneous injection of interferon β-1b 2mL (16 million IU) consecutively and oral ribavirin 400mg twice daily, or the Control group: supportive care alone (1:1).
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
- •Recruited subjects include all adult patients ≥18 years hospitalized for virologic confirmed SARS-CoV-2 infection.
- •All subjects give written informed consent. For patients who are critically ill, requiring ICU, ventilation or confused, informed consent will be obtained from spouse, next-of-kin or legal guardians.
- •Subjects must be available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
排除标准
- •Inability to comprehend and to follow all required study procedures.
- •Allergy or severe reactions to the study drugs
- •Patients taking medication that will potentially interact with l interferon beta-1b or ribavirin
- •Pregnant or lactation women
- •Patients with known history of severe depression
- •Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to recruitment in this study or expect to receive an experimental agent during this study.
- •To participate in an unrelated trial during the current clinical trial. Nevertheless, the patients have the right to withdraw from the current clinical trial to join another clinical trial.
- •Have a history of alcohol or drug abuse in the last 5 years.
- •Have any condition that the investigator believes may interfere with successful completion of the study.
研究组 & 干预措施
Treatment group
5-day course of daily subcutaneous injection of interferon β-1b 2mL (16 million IU) consecutively and oral ribavirin 400mg twice daily plus standard care
干预措施: Interferon beta-1b (Drug)
Treatment group
5-day course of daily subcutaneous injection of interferon β-1b 2mL (16 million IU) consecutively and oral ribavirin 400mg twice daily plus standard care
干预措施: Ribavirin (Drug)
结局指标
主要结局
Clinical symptoms alleviation
时间窗: 7 days
Time to complete alleviation of symptoms as defined by NEWS2 of 0 maintained for 24 hours
次要结局
- Time to negative viral load(7 days)
- Hospitalisation(14 days)
- Inflammatory changes(7 days)
- Adverse events and serious adverse events(30 days)
- Mortality(30 days)