A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of ATYR1923 In Adult Patients With Severe Pneumonia Related to SARS-CoV-2 Infection (COVID-19)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation.
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)
盲法说明
The Investigator, Sponsor, and participant will be blinded to treatment assignment; study center pharmacy personnel will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of SARS-CoV-2 infection by polymerase chain reaction (PCR).
- •Severe pneumonia related to SARS-CoV-2 infection, defined as fever or suspected respiratory infection with radiographic abnormalities suggestive of viral pneumonia, plus at least 1 of the following:
- •Respiratory rate >30 breaths/minute;
- •Severe respiratory distress, as determined by the Investigator;
- •Oxygen saturation (SpO2) ≤93% on room air.
排除标准
- •Participant is intubated/mechanically ventilated.
- •In the opinion of the Investigator, participant's progression to death is imminent.
- •Treatment with immunosuppressant/immunotherapy drugs, including but not limited to interleukin (IL)-6 inhibitors, tumor necrosis factor-alpha (TNF-α) inhibitors, anti-IL-1 agents and janus kinase inhibitors within 5 half-lives or 30 days prior to Day
- •Use of chronic (>30 days) oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day.
- •Weight >165 kg or <40 kg.
研究组 & 干预措施
Efzofitimod 1 mg/kg
Participants will receive single dose of efzofitimod 1 milligrams/kilograms (mg/kg) IV infusion on Day 1.
干预措施: Efzofitimod 1 mg/kg (Drug)
Efzofitimod 3 mg/kg
Participants will receive single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
干预措施: Efzofitimod 3 mg/kg (Drug)
Placebo
Participants will receive placebo matched to efzofitimod IV infusion on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to Day 60
TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. AEs were defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section.
次要结局
- Time to Hospital Discharge(Baseline up to Day 60)
- Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60(Baseline, Day 60)
- Time to Recovery (World Health Organization [WHO] Ordinal Scale Score ≤3)(Baseline up to Day 60)
- Number of Days With Supplemental Oxygen (O2)(Baseline up to Day 60)
- Number of Participants Who Achieved Recovery (WHO Ordinal Scale Score ≤3) by Day 14 and Day 28(Baseline through Day 14 and Day 28)
- Time to Improvement From Inpatient Hospital Admission Based on at Least a 1-Point Reduction in WHO Ordinal Scale Score(Baseline up to Day 60)
- Number of Days With Fever (Temperature >100.4ºF [38.0ºC])(Baseline up to Day 14)