Extension Study in a Cohort of Adult Patients With SARS-CoV-2 Infection Requiring Hospital Admission and Received Treatment With Plitidepsin in the APLICOV-PC Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 10
- 主要终点
- Number and Percentage of Participants With Complications Related to Post COVID-19 Infection
研究概览
简要总结
The main objective of this study is to evaluate the incidence of post-COVID morbidity and characterize the complications profile in patients who participated in the APLICOV-PC study. APLICOV-PC study was a multicenter, randomized, proof-of-concept clinical trial to assess the safety profile of 3 different dose levels of plitidepsin (1,5 mg, 2,0 mg and 2,5 mg) administered three consecutive days, in adult patients with confirmed diagnosis of COVID-19 who require hospital admission.
详细描述
The APLICOV-PC proof of concept study demonstrated the antiviral activity of plitidepsin in terms of reducing viral load, inducing recovery, and impact on lymphocyte reconstitution and other inflammatory parameters.
A percentage of patients, which varies between 10 and 25%, continue to show symptoms at 3 months after contracting the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: For some of them this significantly restricts their life, requiring them to take long-term sickness leave from work, and leaving them with sequelae that may continue for more than one year.
With this study, Pharmamar intends to evaluate whether the treatment with plitidepsin, by attaining a reduction in the viral load and a faster recovery of the patient, could have a relevant impact on the emergence of sequelae resulting from the SARS-CoV-2 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient who participated in the APLICOV-PC study receiving treatment with plitidepsin and who gives consent.
排除标准
- •There are no exclusion criteria for this study.
研究组 & 干预措施
Arm A: Experimental 1
In the APLICOV-PC study, patients of arm A received 1.5 mg of plitidepsin / day for 3 consecutive days (total dose 4.5 mg).
干预措施: Plitidepsin 1.5 mg / day (Drug)
Arm B: Experimental 2
In the APLICOV-PC study, patients of arm B received 2.0 mg of plitidepsin / day for 3 consecutive days (total dose 6.0 mg).
干预措施: Plitidepsin 2.0 mg / day (Drug)
Arm C: Experimental 3
In the APLICOV-PC study, patients of arm C received 2.5 mg of plitidepsin / day for 3 consecutive days (total dose 7.5 mg).
干预措施: Plitidepsin 2.5 mg / day (Drug)
结局指标
主要结局
Number and Percentage of Participants With Complications Related to Post COVID-19 Infection
时间窗: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
Number and percentage of patients who developed complications related to post COVID-19 infection
次要结局
- Patients Requiring Oxygen Therapy(Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.)
- Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not).(Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months..)
- Ratio of Partial Pressure Arterial Oxygen (PaO2) and Fraction of Inspired Oxygen (FiO2)(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- Lung Diffusion Testing(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- Forced Expiratory Volume 1 (FEV1)(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- Patients With Alterations in Chest Radiography(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- Patients With Electrocardiogram Alterations(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- Patients With ≥Grade 2 Alterations in Laboratory Parameters(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- Modified Medical Research Council (mMRC) Dyspnea Scale(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- FEV1/FVC(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- Forced Vital Capacity (FVC)(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- Arterial Oxygen Saturation (SaO2)(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- Barthel Index(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- Patients Requiring Hospital Readmission(Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.)
- 6 Minute Walking Test (Total Distance)(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- 6 Minute Walking Test (Expected Distance)(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- 6 Minute Walking Test (Percentage of Predicted Distance)(At study inclusion, an average of 12 months after end of APLICOV-PC study.)
- 6 Minute Walking Test (Number of Laps of 60 m)(At study inclusion, an average of 12 months after end of APLICOV-PC study.)