A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of EG-009A Compared to Dexamethasone in Patients With Moderate/Severe (Non-intubated, Non-mechanical Ventilation) COVID-19 Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- The proportion of patients alive and without respiratory failure
研究概览
简要总结
To study signals of efficacy and safety of a currently available dosage form (IM) of EG-009A in reducing the severity of respiratory disease in patients hospitalized with SARS-CoV-2 virus.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18), or willing and able to provide assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures
- •Patient is aged at least 18 years, enrollment of patients < 65 years old will be limited to 20% of the total with the first 50% of enrollment conducted solely among those patients ≥ 55 years old.
- •Patient has SARS-CoV-2 pneumonia from COVID-19 infection of moderate to serious severity (WHO Ordinal Scale for Clinical Improvement score of 4 or 5)
- •Patient has COVID-19 symptoms ≤ 10 days and at least 1 of the following:
- •Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.)
- •O2 saturation (SpO2) ≤ 94% on room air
- •Requiring supplemental O2 (patients on HFNO ≤ 20 L/min with FiO2 < 0.5 are allowed), but not requiring mechanical ventilation.
- •Note: Patients admitted with immediate need for mechanical ventilation are of a severity too critical for inclusion into this protocol. Patients who are already in the hospital and have been removed from mechanical ventilation are not eligible.
排除标准
- •Patient has SARS-CoV-2 infection of severity ≥ 6 on COVID-19 WHO Ordinal Scale for Clinical Improvement or for those subjects who have a WHO Ordinal Scale for Clinical Improvement score of 5, nasal intermittent positive pressure ventilation (NIPPV) or requiring HFNO > 20 L/min with FiO2 ≥ 0.5 will be exclusionary.
- •Patient is currently receiving extracorporeal membrane oxygenation, nitric oxide therapy, or high-frequency oscillatory ventilation
- •Patient is unlikely to survive for > 24 hours from randomization, in the opinion of the investigator
- •Patient has a history of chronic oxygen use or any pre-existing respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
- •Patient has a history of venous thromboembolism, DVT, or pulmonary embolus
- •Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drug's PK, PD, or biological activity (if known), whichever is longer, prior to the first dose of study drug in this study or is currently participating in another clinical study.
研究组 & 干预措施
Arm 2: SOC + DEX + Low Dose EG-009A
In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A Low dose for 3 additional weeks.
干预措施: EG-009A (Drug)
Arm 1: SOC + DEX + EG-009A placebo
In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A placebo for 3 additional weeks.
干预措施: EG-009A Placebo (Drug)
Arm 1: SOC + DEX + EG-009A placebo
In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A placebo for 3 additional weeks.
干预措施: Standard of Care (Drug)
Arm 1: SOC + DEX + EG-009A placebo
In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A placebo for 3 additional weeks.
干预措施: Dexamethasone (Drug)
Arm 2: SOC + DEX + Low Dose EG-009A
In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A Low dose for 3 additional weeks.
干预措施: Standard of Care (Drug)
Arm 2: SOC + DEX + Low Dose EG-009A
In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A Low dose for 3 additional weeks.
干预措施: Dexamethasone (Drug)
Arm 3: SOC + DEX + High Dose EG-009A
In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A High dose for 3 additional weeks.
干预措施: EG-009A (Drug)
Arm 3: SOC + DEX + High Dose EG-009A
In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A High dose for 3 additional weeks.
干预措施: Standard of Care (Drug)
Arm 3: SOC + DEX + High Dose EG-009A
In addition to the standard of care (SOC), patients will receive dexamethasone (DEX) for 10 days and EG-009A High dose for 3 additional weeks.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The proportion of patients alive and without respiratory failure
时间窗: First dose date to 28 days treatment dosing period
Patients will be assessed for COVID-19 Ordinal Scale for Clinical Improvement scores and respiratory status throughout the study
次要结局
未报告次要终点