EUCTR2021-000516-37-HU进行中（未招募）1 期
A Phase I/II open-label study for Azacitidine, initiated with a lead-in dose escalation pharmacokinetic Phase I/b part in the 20–50 mg/m2 range to evaluate safety in Hospitalized COVID-19 Patients in Severe Infection with Risk of Progression as Add-on Therapy to Standard of Care, continued with a Randomized, Controlled, Open-Label Adaptive Phase II part to Determine Efficacy and Safety - The efficacy and the safety of TS-020 in acute viral infection
TurnSole Biologics Llc0 个研究点目标入组 50 人开始时间: 2021年2月4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
- 50
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.Trial subjects are in 18-75 years of age.
- •2.Severe COVID-19 infected patient
- •(criteria applicable as one of the following):
- •- Respiratory rate >30 breaths/min or rapidly worsening respiratory gas exchange (PaO2 <80 Hgmm on room air) OR
- •- Evidence of rales/crackles on physical examination and SpO2 ?93% on room air, OR
- •- increasing need for O2 supplementation greater than >50% Venturi mask, including use of non-invasive mechanical ventilation (NIMV) or High Flow Nasal Cannula, OR
- •- Acute Lung Injury physiology confirmed by PaO2/FiO2 ratio of ?300 Hgmm, OR
- •- CT scan of the chest: presence of bilateral pulmonary infiltrates or 50% progression within 48 hours OR
- •- COVID-19 infection associated secondary hemophagocytic lymphohistiocytosis (sHLH)/ macrophage activation syndrome (MAS)
- •- HS scores greater than 169
- •3.Confirmed SARS-CoV2 infection, by specific lab results at least one positive rt-PCR or IgA/IgM test (1x SARS-CoV-2 PCR positive or if SARS-CoV-2 PCR negative, within 48 hours must have the 2. test SARS-CoV-2 PCR positive)
- •4.Female subjects: with childbearing potential are under efficient contraception, or in post-menopause.
- •5.The trial subject has the willingness to comply with study procedures and to give voluntary written informed consent signed and dated prior to enrolment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Clinical signs of critical status:
- •a)SpO2 ? 90%, while oxygen supply with FiO2 > 100%
- •b)PaO2/FiO2 ? 200 mmHg
- •c)Respiratory failure which requiring mechanical ventilation
- •e)Combined with organ failure other than lung, need to be admitted to ICU
- •2.Known sensitivity/allergy to azacitidine or other class effect pyrimidine nucleoside analogues, or hypersensitivity to any of the excipients listed.
- •3.Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) /alkaline phosphatase (ALP) = 3x upper limit of normal (ULN) and Total Bilirubin (TBILI) =2x ULN; or Creatinine clearance <30 mL/min.
- •4.Neutrophil count (ANC) below 1500/mcl,
- •5.Haemoglobin (Hgb)<7.0 mmol/L
- •6.Platelet count below 100,000/mcl
- •7.Advanced malignant hepatic tumors / patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment.
- •8.Cardial disorders by Echocardiography or by medical history (arrhythmia, atrialfibrillation or fluttern, sick sinus syndrome (SSS) ventricular arrhythmia, coronary disorders, AMI, EF ?50% or valve disorders (excl. mitralis prolapsus). Severe heart failure/ with a history of severe congestive heart failure, (NYHA III-IV, or NYHA IV)
- •9.Severe chronic renal disorder, or renal impairment requiring dialysis (eGFR<30)
- •10.Ongoing/suspected sever bacterial infection
- •11.Acute cerebrovascular disease within 3 months prior to enrolment
- •12.Pregnancy or breast-feeding (latter can be stopped)
- •13.Has received other immunomodulatory drug in the past for the treatment of other medical conditions
- •14.Previously diagnosed with HIV (HIV-Ab test positive) or anti-HCV antibodies positive
- •15.Obesity of 35 BMI or above
- •16.Uncontrolled hypertension (RR >170/100 Hgmm) or above.
- •17.Dementia, or inability to give informed consent
- •18.Any serious medical condition or abnormal clinical laboratory tests which in the judgement of the investigator may compromise patient safety should he/she participates in the study.
- •19.Use of concomitant medication:
- •- Drugs with reported antiviral activity against SARS-CoV-2 included hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, etc. at baseline or within 7 days prior randomization unless a part of standard of care. With the exception of prior or ongoing treatment with antivirals of favipiravir, remdesivir (or generics of these products) are allowed.
- •- Concurrent immunomodulating biologics or use of Palifermin, Dipyrone, Deferiprone, interferon-alpha.
- •20.Individuals, in the opinion of the investigator, where progression to death is imminent and inevitable in the next 24 hours irrespective of treatment provision
- •21.Any medical condition, per opinion of PI that would affect subject safety and/or compliance
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