EUCTR2020-005951-19-GR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6月16日最近更新:
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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. Documented diagnosis of SARS-CoV-2 infection as determined by either qualitative polymerase chain reaction (PCR) or antigen test by local laboratory from oro/nasopharyngeal exudate (or other respiratory specimen) collected no more than 72 hours prior to study treatment on Day 1
- •3. Patient meets category 5 on the 11-point WHO Clinical Progression
- •Scale (Appendix 13): requires hospitalization and oxygen by mask or
- •nasal prongs/cannula
- •4. A maximum of 10 days from onset of COVID-19 symptoms 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 except if the patient has had
- •recent (ie, in the last week) shivering episodes or trauma. In that case, the level of CPK should be =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 or urine 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. Patients in the control arm must use effective contraception at the time indicated in the approved product information (summary of product characteristics [SmPC] or leaflet). If no information is available in the approved product information, patients in the control arm must use effective contraception for at least one week after the study completion or the time indicated based on the investigator's discretion.
- •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 (Barthel index
- •<90/100, Appendix 7) or chronic oxygen therapy
- •2. Having received treatment for COVID-19 in another clinical trial in the prior 4 weeks, except documented allocation in a placebo arm.
- •3. Evidence of respiratory failure at the time of randomization, based on resource utilization requiring at least one 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 one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)
- •4. Patients with severe COVID 19, meeting score >5 on the 11 point
- •WHO Clinical Progression Scale or presenting during the screening any of
- •clinical signs indicative of severe systemic illness, such as respiratory
- •rate =30 per minute, heart rate =125 per minute, or PaO2/FiO2 <300
- •5. Patients receiving treatment with antiviral therapy against SARS-CoV-2 (either small molecules or antibodies, convalescent plasma,
- •monoclonal antibodies, IL-6 receptor inhibitor, corticosteroids, or immunomodulatory drugs within 2 weeks before enrolment. Prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if:
- •o The total daily dose is not higher than 6 mg of dexamethasone base
- •(equivalent to dexamethasone phosphate 7.2 mg/day) or equivalent
- •glucocorticoids
- •o The duration of the treatment does not exceed 72 hours prior to study treatment Day 1
- •6. History of live vaccination within the last 4 weeks prior to study enrolment. Regulatory approved, nonreplicative viral vector-based vaccines are allowed if given not earlier than 1 week previous to Day 1.
- •7. Patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study
- •8. Patients receiving treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers (see Appendix 4)
- •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. Patients with uncontrolled known primary or secondary immunodeficiency, including chronic treatment with glucocorticoids (ie, prednisone at a daily dose of >10 mg for >1 month, or other
- •glucocorticoid at equipotent dose)
- •11. 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 12-lead
- •electrocardiogram (ECG) at screening;
- •- History of known congenital or acquired QT prolongation;
- •- Uncorrected hypokalaemia, hypocalcaemia (adjusted) and/or hypomagnesemia at screening;
- •- Concomitant treatments with drugs known to be associated with
研究者
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