Double-blind, Randomized, Placebo-controlled Phase 3 Study Evaluating Efficacy and Safety of IgPro20 (Subcutaneous Immunoglobulin, HIZENTRA®) in Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- CSL Behring
- 入组人数
- 16
- 试验地点
- 68
- 主要终点
- Proportion of participants no longer meeting diagnostic criteria of post-COVID POTS as measured by standardized standing test (ie, no longer experiencing HR increase of ≥ 30 bpm, in the absence of 20 mmHg decrease of SBP [orthostatic hypotension])
研究概览
简要总结
This is a prospective, phase 3, multicenter, double-blind, randomized placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics (PK) of repeat doses of IgPro20 in participants with post SARS-CoV-2 infection 2019 postural orthostatic tachycardia syndrome (post-Coronavirus Disease 2019 [COVID-19] POTS [post-COVID-POTS]).
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
Period 1 (double-blind): Participant, Care Provider, Investigator, Outcomes Assessor
Period 2 (open-label): No masking
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
- •Provide written informed consent and be willing and, in the opinion of the investigator, able to adhere to all protocol requirements.
- •Males and females aged ≥ 18 at the time of providing written informed consent.
- •Diagnosis of post-COVID POTS, defined by both a preceding COVID-19 infection based on confirmed historical documentation and onset of POTS symptoms developing within 4 months after COVID-19 infection as defined per consensus criteria.
- •COMPASS-31 score of at least 40 at the Screening visit.
- •Positive confirmatory standardized standing test (ie, HR increase of ≥ 30 bpm [≥ 40 bpm for participants aged 18 to 19 years] within 10 minutes in the absence of orthostatic hypotension) at the Screening visit.
排除标准
- •Treatment with Immunoglobulin G (IgG) or plasmapheresis within 12 weeks before Screening
- •Symptoms and / or diagnosis of or receiving treatment for POTS before COVID-19 infection
- •Prior diagnosis of or receiving current treatment at Screening for the following conditions (unless onset was related to the inciting POTS-associated COVID-19 infection): certain neurologic, autoimmune, endocrine, cardiac, or other disorders, and pre-existing psychiatric disorders
- •Presence of active infections, including human immunodeficiency virus infection, hepatitis B, hepatitis C, active SARS-CoV-2 infection, or any uncontrolled systemic infection
研究组 & 干预措施
IgPro20
干预措施: IgPro20 (Biological)
Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Proportion of participants no longer meeting diagnostic criteria of post-COVID POTS as measured by standardized standing test (ie, no longer experiencing HR increase of ≥ 30 bpm, in the absence of 20 mmHg decrease of SBP [orthostatic hypotension])
时间窗: At screening, and at week 25
Proportion of Participants No Longer Meeting Diagnostic Criteria of Post-COVID POTS as Measured by Standardized Standing Test (ie, No Longer Experiencing HR Increase of ≥30 Bpm, in the Absence of 20 mmHg Decrease of SBP [Orthostatic Hypotension])
时间窗: At Baseline and at Week 25
The reported data reflect the percentage of participants who no longer met the diagnostic criteria for Post-Coronavirus Disease 2019 (COVID) Postural Orthostatic Tachycardia Syndrome (POTS), as assessed by a standardized standing test (i.e., no longer experiencing a heart-rate (HR) increase of \>=30 bpm in the absence of a 20 mmHg decrease in systolic blood pressure \[SBP; orthostatic hypotension\]), among participants evaluated at that visit. The Baseline data represent the proportion of participants who were meeting the diagnostic criteria for post-COVID POTS.
次要结局
- Change from baseline in orthostatic intolerance score of COMPASS-31(At baseline and at week 25)
- Change from baseline in COMPASS-31 total score(At baseline and at week 25)
- Percentage of participants with TEAEs, related TEAEs, serious TEAEs and related serious TEAEs(After treatment, for up to 57 weeks)
- Percentage of participants with ECG abnormalities(At baseline, at Week 25 and at Week 53)
- Number of participants with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs and related serious TEAEs(After treatment, for up to 57 weeks)
- Number of participants with electrocardiogram (ECG) abnormalities(At baseline, at Week 25 and at Week 53)
- Change from baseline in heart rate increase within 10 minutes of standing test(At baseline and at Week 25)
- Change from baseline in ECG abnormalities(At baseline, at Week 25 and at Week 53)
- Number of Participants With Change From Baseline in Clinically Significant ECG Abnormalities(From Baseline up to Week 45)
- Percentage of Participants With Change From Baseline in Clinically Significant ECG Abnormalities(From Baseline up to Week 45)
- Change From Baseline in Orthostatic Intolerance (OI) Score of Composite Autonomic Symptom Score 31 (COMPASS-31)(At Baseline and at Week 25)
- Change From Baseline in COMPASS-31 Total Score(At Baseline and at Week 25)
- Change From Baseline in Heart Rate Increase Within 10 Minutes of Standing Test(At Baseline and at Week 25)
- Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE(Up to Week 45)
- Percentage of Participants With TEAE, Related TEAE, Serious TEAE and Related Serious TEAE(Up to Week 45)
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities(Up to Week 45)
- Percentage of Participants With Clinically Significant ECG Abnormalities(Up to Week 45)