A Double Blind, Placebo-Controlled, Randomized, Phase Ib Clinical Study of ApTOLL for the Treatment of COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Number of patients with treatment-related alterations coagulation parameters
研究概览
简要总结
There is a clear and urgent medical need of developing new medicinal products for COVID-19 since there are poor pharmacological tools to block the progression of patients to cytokine storm syndrome (CSS). To this aim, this Phase Ib clinical study (APTACOVID) pretends to determine whether ApTOLL, in combination with the standard of care, is safe and shows any biological effect) in those patients infected with SARS-CoV-2 who are not developed CSS yet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women with age ≥18 and ≤85 years.
- •In case of women of childbearing potential (WOCBP), they should confirm menstrual period and a negative highly sensitive urine or serum pregnancy test to be included.
- •Laboratory-confirmed SARS-CoV-2 infection.
- •Informed consent obtained .
- •Hypoxia (SpO2<95%).
- •Documented lung opacities/infiltrates.
- •Confirmed hyperinflammation.
排除标准
- •Onset of symptoms of COVID-19 >14 days.
- •Pregnant or nursing (lactating) women.
- •Hospitalized >10 days for COVID-
- •Need of high concentration non-rebreather mask, high-flow nasal cannula , non-invasive mechanical ventilation or invasive mechanical ventilation.
- •Systolic blood pressure < 90 mmHg.
- •Serious concomitant illness.
- •Recent treatment with cell-depleting therapies.
- •Enrolled in another clinical trial.
- •Severe renal dysfunction.
- •In the opinion of the investigator, unable to comply with the requirements to participate in the study.
研究组 & 干预措施
Placebo
Nine COVID-19 patients (three from each treatment-group) treated with saline intravenous infusion
干预措施: Saline (Other)
Dose 1
Seven COVID-19 patients treated with ApTOLL (0.05mg/kg) intravenous infusion
干预措施: ApTOLL (Drug)
Dose 2
Seven COVID-19 patients treated with ApTOLL (0.1mg/kg) intravenous infusion
干预措施: ApTOLL (Drug)
Dose 3
Seven COVID-19 patients treated with ApTOLL (0.2mg/kg) intravenous infusion
干预措施: ApTOLL (Drug)
结局指标
主要结局
Number of patients with treatment-related alterations coagulation parameters
时间窗: From dosing to day 28 after administration
Protrombine Time (PT) and activated Partial Tromboplastine Time (aPTT)
Number of patients with treatment-related alterations Complement Factors
时间窗: From dosing to day 28 after administration
Complement activation determined in blood
Incidence of Death
时间窗: From dosing to day 28 after administration
Number of dead patients at the end of the study
Incidence of Adverse Events as assessed by MedDRA
时间窗: From dosing to day 28 after administration
Adverse events that occur during the study
次要结局
未报告次要终点
研究者
Macarena Hernández Jiménez
PhD
aptaTargets S.L.