EUCTR2020-005951-19-BG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5月10日最近更新:
适应症
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 determined by either
- •qualitative polymerase chain reaction (PCR), antigen test by local
- •laboratory, or any other validated method approved by the local health
- •authority, from appropriate biological samples 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 14 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 =500/mm3 (0.5 x 10^9/L)
- •Platelet count =75,000/mm3 (75 x 10^9/L)
- •Alanine transaminase (ALT), aspartate transaminase (AST) =3 x upper
- •limit of normal (ULN)
- •Serum bilirubin =1 x ULN (or direct bilirubin <1 x ULN when total
- •bilirubin is above ULN).
- •Calculated creatinine clearance =30 mL/min (Cockcroft-Gault
- •Creatine phosphokinase (CPK) =2.5 x ULN except if the patient has had
- •recent (i.e., 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
- •8. Females of reproductive capacity must have a negative serum or urine
- •pregnancy test by local laboratory at study enrolment and must be nonlactating
- •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 during 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 impairment in general health condition
- •for whatever reason except COVID-19, with a severe dependancy for
- •daily living activities (Barthel index <60/100) 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 randomisation, based on resource
- •utilisation requiring at least one of the following: endotracheal
- •intubation and mechanical ventilation, O2 delivered by high-flow nasal
- •cannula, non-invasive positive pressure ventilation, ECMO, or clinical
- •diagnosis of respiratory failure
- •4. Patients with severe COVID 19, meeting score >5 on the 11-point
- •WHO Clinical Progression Scale or presenting after an initial stabilisation
- •prior to randomisation, any of clinical signs indicative of severe systemic
- •illness: respiratory rate =30/min, heart rate =125/min, or PaO2/FiO2
- •<300. In case a direct measure of PaO2 has not been obtained, it should
- •be imputed according to a referenced formula. For sites located over
- •1000m above sea level, PaO2/FiO2 ratio will be adjusted
- •5. Patients receiving, at randomisation, treatment with antiviral therapy
- •against SARS-CoV-2 or requiring anti-inflammatory/immunomodulating
- •drugs beyond glucocorticoids with the exceptions listed below
- •Prior administration of dexamethasone or equivalent glucocorticoid
- •might be acceptable if:
- •o The total daily dose is not higher than 10mg of dexamethasone
- •phosphate (equivalent to dexamethasone base 8.25 mg/day) or
- •equivalent glucocorticoids
- •o The duration of the treatment does not exceed 72h prior to study
- •treatment Day 1
- •Prior administration of an antiviral might be acceptable in the
- •following circumstances:
- •o For small molecules (e.g., remdesivir, molnupiravir,
- •nirmaltrevir/ritonavir), they must have been given for an earlier stage of
- •the disease, outside a clinical trial, and there should be a documentation
- •of objective clinical deterioration plus evidence of persisting positivity
- •for SARS-CoV-2 in appropriate biological samples. Last dose of previous
- •antiviral drugs should have been administered at least 24 h before
- •randomisation.
- •o For antiviral monoclonal antibodies, they must have been given for an
- •earlier stage of the disease (including pre-exposure prophylaxis),
- •outside a clinical trial, and there should be a documentation of objective
- •clinical deterioration plus evidence of persisting positivity for SARS-CoV-
- •2 in appropriate biological samples. Last dose of antiviral monoclonal
- •antibodies should have been administered at least 1 week before
- •randomisation.
- •6. Patients receiving treatment with chloroquine or derivatives within 8
- •weeks before enrolment or during the study
- •7. Patients receiving treatment with strong cytochrome P450 3A4
- •inhibitors or inducers
- •8. Viral illness (other than COVID-19) requiring therapy, except for
- •patients with treated and adequately controlled (undetectable) HIV
- •9. Patients with uncontrolled known primary or secondary
- 另有 8 项未显示
研究者
相似试验
进行中（未招募）
1 期
This study is to determine the efficacy and safety of Two Dose Levels of Plitidepsin compared with the group of control for patients requiring hospitalization due to COVID-19.EUCTR2020-005951-19-ESPharma Mar, S.A.205
尚未招募
3 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 Infectio07.1 COVID-19, virusCOVID-19, virusU07.1PER-031-21Pharma Mar S.A.
进行中（未招募）
1 期
This study is for research purposes only to test plitidepsin for patients requiring hospitalization due to COVID-19.EUCTR2020-005951-19-PTPharma Mar, S.A.205
进行中（未招募）
1 期
This study is for research purposes only to test plitidepsin for patients requiring hospitalization due to COVID-19.moderate COVID-19 infectionMedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862EUCTR2020-005951-19-GRPharma Mar, S.A.609
进行中（未招募）
1 期
This study is for research purposes only to test plitidepsin for patients requiring hospitalization due to COVID-19.EUCTR2020-005951-19-FRPharma Mar, S.A.609