EUCTR2020-005951-19-FR进行中（未招募）1 期
A Phase 3, Multicentre, Randomised, Controlled Trial to Determine the Efficacy and Safety of Two Dose Levels of Plitidepsin Versus Control in Adult Patients Requiring Hospitalisation for Management of Moderate COVID-19 Infection - APL-D-003-20
Pharma Mar, S.A.0 个研究点目标入组 609 人开始时间: 2021年4月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 609
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent obtained prior to initiation of any study-specific procedures and study treatment
- •2. Laboratory confirmed SARS-CoV-2 infection as determined by qualitative polymerase chain reaction (PCR) by local laboratory from oro/nasopharyngeal exudate (or other respiratory specimen) collected no more than 24 hours prior to study treatment on Day 1
- •3. Admitted to hospital as clinically indicated for management of moderate SARS-CoV-2 (COVID-19) infection, defined by the following criteria:
- •Positive PCR test for SARS-CoV-2
- •Symptoms of moderate illness with COVID-19, which could include any symptoms of mild illness or shortness of breath with exertion
- •Clinical signs suggestive of moderate illness with COVID-19 such as respiratory rate =20 breaths but <30 breaths per minute, SpO2 >93% but <95% on room air at sea level, heart rate =90 but <125 beats per minute, and requiring O2 supplementation. If SpO2 on room air is not possible to be measured, the ratio PaO2/FiO2 should be >= 300 mm Hg; in addition, if the site is located at high altitude over sea level (> 1000 m), the ratio PaO2/FiO2 should be adjusted
- •No clinical signs indicative of severe illness, which could include shortness of breath at rest or respiratory distress, or PaO2/FiO2 ratio < 300 mm Hg (sea level).
- •4. Onset of COVID-19 symptoms no later than 6 days prior to initiation of study treatment on Day 1
- •5. Male or female aged =18 years
- •6. Adequate bone marrow, liver, kidney, and metabolic function, defined by the following tests performed at local laboratory:
- •Absolute neutrophil count =1000/mm3 (1.0 x 109/L)
- •Lymphocyte count =500/mm3 (0.5 x 109/L)
- •Platelet count =100 000/mm3 (100 x 109/L)
- •Haemoglobin >9.0 g/dL
- •Alanine transaminase (ALT), aspartate transaminase (AST) =3 x upper limit of normal (ULN)
- •Serum bilirubin =1 x ULN
- •Calculated creatinine clearance =30 mL/min (Cockcroft and Gault formula)
- •Creatine phosphokinase =2.5 x ULN
- •7. Agree not to participate in another interventional clinical trial through Day 31
- •8. Females of reproductive capacity must have a negative serum pregnancy test by local laboratory at study enrolment and must be non-lactating
- •9. Females and males with partners of child-bearing potential must use effective contraception while on study treatment and for 6 months after last dose of plitidepsin.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 433
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 176
排除标准
- •1. Subjects with a pre-baseline (ie, in the prior month) impairment in general health condition for whatever reason except COVID-19, requiring either assistance for daily living activities or chronic oxygen therapy
- •2. Participating in another clinical trial for treatment of COVID-19 infection or patients previously enrolled in clinical trials and currently in follow-up, or patients previously vaccinated for COVID-19
- •3. Evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least 1 of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)
- •4. Patients clinically indicated for management of SARS-CoV-2 (COVID-19), with baseline disease severity rated as severe (if positive testing by standard RT-PCR assay or equivalent test, symptoms suggestive of severe illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress, clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate =30 per minute, heart rate =125 per minute, SpO2 =93% on room air at sea level, or PaO2/FiO2 <300)
- •5. Patients receiving treatment with antivirals, IL-6 receptor inhibitor, corticosteroids, or immunomodulatory drugs for COVID-19 infection within 4 weeks before enrolment
- •6. History of live vaccination within the last 4 weeks prior to study enrolment; subjects must not receive live, attenuated influenza vaccine within 4 weeks before enrolment or at any time during the study
- •7. Patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study
- •8. Receiving treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers
- •9. Viral illness (other than COVID-19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection are eligible
- •10. Any of the following cardiac conditions or risk factors:
- •- Sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrio-ventricular block of any degree (PR >200 msec), or any other bradyarrhthymia (< 50 beats/min), except for patients with permanent pacemakers;
- •- Cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months;
- •- Known abnormal value of left ventricular ejection fraction (LVEF < LLN), unless documented confirmation of recovery (LVEF > LLN) in the previous month;
- •- QT interval corrected using Fridericia’s formula (QTcF) >450 msec for males or >470 msec for females, based on triplicate ECG at screening;
- •- History of known congenital or acquired QT prolongation;
- •- Uncorrected hypokalaemia, hypocalcaemia (adjusted) and/or hypomagnesemia at baseline;
- •- Concomitant treatments with drugs known to be associated with a risk of QT prolongation or cardiac arrhythmia (Appendix 8a); or
- •- Troponin test performed at local laboratory > 1.5 x ULN.
- •11. Pre-existing neuropathies of any type Grade =2
- •12. Hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol).
- •13. Females who are pregnant (negative serum pregnancy test required for all females of child-bearing p
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