Randomized, Controlled, Open Label, Phase 2 Clinical Trial of Interferon-β-1a (IFNβ-1a) in COVID-19 Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Time to negative conversion of SARS-CoV-2 nasopharyngeal swab
研究概览
简要总结
Pharmacological therapies of proven efficacy in coronavirus disease 2019 (COVID-19) are still lacking.
Since two clinical stages of COVID-19 are emerging, an early one with typical clinical characteristics of a viral infection (fever, malaise, cough) and a later one with pneumonia leading to progressive respiratory failure, associated with heavy, cytokine-mediated, inflammation, an intervention by a compound possessing both antiviral activity and immunomodulatory effects would be most effective at the earliest possible stage.
The purpose of this clinical trial is to test the efficacy of Interferon-β-1a (IFNβ-1a), in COVID-19 patients in an open label, randomized clinical trial.
The design of the study is to test IFNβ-1a in addition to standard of care compared with standard of care alone.
The primary outcome is the time to negative conversion of Severe Acute Respiratory Syndrome-CoronaVirus-2 (SARS-CoV-2) nasopharyngeal swabs.
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
- •Informed consent signed
- •Patients hospitalized with confirmed swab RT-PCR detection of SARS-CoV-2
- •X-ray and/or CT diagnosed pneumonia
- •Age >=18 years
- •Clinical status defined as 3, 4 or 5 on the 7-point ordinal scale
排除标准
- •Known allergy or hypersensitivity to IFNß-1a or IFNß-1b
- •Presence of severe concomitant illnesses/medical conditions that in the physician opinion do not allow participation to the study
- •Pregnant or lactating females
- •History of major depression disorder or suicidal attempt or suicidal ideation
- •Spontaneous blood alanine aminotransferase/aspartate aminotransferase (ALT/AST) levels > 5 times the upper limit of normal
- •Clinical status defined as 1, 2, or 6 on the 7-point ordinal scale
研究组 & 干预措施
IFNβ 1a
干预措施: Interferon-ß-1a (Drug)
Standard care
干预措施: Standard of Care (SOC) (Combination Product)
结局指标
主要结局
Time to negative conversion of SARS-CoV-2 nasopharyngeal swab
时间窗: From baseline to day 29
Viral load will be measured by Real Time-Polymerase Chain Reaction (RT-PCR)
次要结局
- Oxygenation free days in the first 28 days(From baseline to day 29)
- Improvement in clinical severity score (a)(Baseline, days 7, 15, 21, 29)
- Changes from baseline in pulmonary computed tomography (CT) imaging severity score(Baseline, day 21; extra follow up at 90 days)
- Incidence of new oxygen use, non-invasive ventilation, or high flow oxygen devices during the trial(From baseline to day 29)
- Mortality rate(From baseline to day 29)
- Duration of hospital stay expressed in days(From baseline to day 29)
- Viral load measured on plasma with RT-PCR(Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29)
- Ventilator free days in the first 28 days(From baseline to day 29)
- Incidence of new mechanical ventilation use during the trial(From baseline to day 29)
- Improvement in clinical severity score (b)(Baseline, days 7, 15, 21, 29)
- Number of patients transferred to Intensive Care Unit (ICU)(From baseline to day 29)
研究者
Emanuele Bosi
Professor
IRCCS San Raffaele