A Phase II Multi-Center, Double-Blind, Randomized and Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta-1a in Comparison to Dexamethasone for the Treatment of Hospitalized Patients With COVID-19 Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale
研究概览
简要总结
This double-blinded, randomized study is being conducted to see if the investigational new drug called FP-1201-lyo - intravenous Interferon beta-1a, hereafter IV IFN beta-1a, can help patients recover more quickly from COVID-19 and prevent worsening of the condition. To understand if IV IFN beta-1a can help treat patients with COVID-19, this study drug will be compared to dexamethasone.
Study subjects will be treated daily with IV IFN beta-1a 10 μg or IV dexamethasone for 6 consecutive days while hospitalized and will undergo daily assessments while in hospital for a maximum of 28 days. Study specific assessments will be collected at pre-dose Day 1 through Day 28 (PD and PIM assessments), in addition, clinical routine assessments will be utilized for safety and efficacy assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will be performed in a double-blind and randomized manner.
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
- •Age ≥18 years
- •Positive SARS-CoV-2 test by PCR (polymerase chain reaction) or other diagnostic method within the past 7 days
- •Admission to hospital with respiratory symptoms of COVID-19 requiring hospital care and oxygen supplementation (≤ 8L/min)
- •Respiratory symptom onset no more than 7 days prior to hospital arrival
- •Informed consent from the subject or the subject's personal legal representative or a professional legal representative must be available
排除标准
- •Unable to screen, randomize and administer study drug within 48 hours from arrival to hospital
- •Systemic corticosteroid, baricitinib or tofacitinib (or other JAK-STAT signalling pathway inhibitors) therapy within 7 days prior to arrival to hospital or planned for the next days
- •Known hypersensitivity or contraindication to natural or recombinant IFN-beta-1a or its excipients, or to dexamethasone or its excipients
- •Currently receiving IFN-beta-1a therapy
- •Home assisted ventilation (via tracheotomy or non-invasive) except for Continuous Positive Airway Pressure (CPAP) / Bilevel Positive Airway Pressure (BIPAP) used only for sleep-disordered breathing
- •Participation in another concurrent interventional pharmacotherapy trial during the study period
- •Decision to withhold life-sustaining treatment; patient not committed to full support (except DNR after cardiac arrest only)
- •Woman known to be pregnant, lactating or with a positive pregnancy test (urine or serum test)
- •Subject is not expected to survive for 24 hours
- •Subject has liver failure (Child-Pugh grade C)
- •Any clinical condition that in the opinion of the attending clinician or Investigator would present a risk for the subject to participate in the study
研究组 & 干预措施
IV IFN beta-1a
Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.
干预措施: IFN beta-1a (Drug)
IV Dexamethasone
Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale
时间窗: Day 14
WHO 9-point ordinal scale: 0 - No detectable infection 1. - Not hospitalized, no limitations on activities 2. - Not hospitalized, limitation on activities 3. - Hospitalized, not requiring supplemental oxygen 4. - Hospitalized, requiring supplemental oxygen 5. - Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. - Hospitalized, on invasive mechanical ventilation 7. - Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) 8. - Death
次要结局
- Overall (All-cause) Mortality at Day 28 and Day 90(Day 28 and Day 90)
- In-hospital Mortality at Day 28 and Day 90(Day 28 and Day 90)