CTRI/2021/09/036115Other3 期
A Label Extension, Single Arm, Multicentric, Two Dosage, Phase III Study Assessing the Efficacy and Safety of Intravenous Administration of stempeucel® (Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells) in Patients with Moderate to Severe Acute Respiratory Distress Syndrome due to COVID-19
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 56
- 试验地点
- 5
- 主要终点
- Percent mortality 28 days after administration of BMMSCs
研究概览
简要总结
This is a A Label Extension, Single Arm, Multicentric, Two Dosage, Phase III Study Assessing the Efficacy and Safety of Intravenous Administration of stempeucel® (Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells) in Patients with Moderate to Severe Acute Respiratory Distress Syndrome due to COVID-19
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males or females of age 18 to 65 years of Indian origin and diagnosed with COVID-19 by reverse transcription polymerase chain reaction (RT-PCR)/TrueNat/CBNAAT assay.
- •2.Informed consent by the patient or his/her legal representative in case the patient is not capable of giving the consent.
- •3.Patients diagnosed with COVID-19 causing moderate and severe ARDS as per the Berlin ARDS definition.
- •a.Respiratory failure within one week of a known clinical insult or new and/or worsening respiratory symptoms b.Respiratory failure not fully explained by cardiac failure or fluid overload c.Moderate to severe hypoxemia must be present, defined as the ratio of PaO2/FiO2 with PEEP ≥5 cmH2O or non-ventilated •Moderate ARDS: PaO2/FiO2 >100 mmHg and ≤200 mmHg with PEEP ≥5 cmH2O, or non-ventilated or Severe ARDS: PaO2/FiO2 ≤100 mmHg with PEEP ≥5 cmH2O, or non-ventilated d.Bilateral opacities 4.Patients who can start receiving BMMSCs within 72 hours after the diagnosis of ARDS.
排除标准
- •1.Any other cause of ARDS not attributable to SARS-CoV
- •2.Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments in the opinion of the investigator.
- •3.Presence of any active malignancy.
- •4.Any end stage organ disease as assessed by investigator which may possibly affects the safety of the study drug.
- •5.Patient with history of any stem cell transplant in the past.
- •6.Moderate to severe liver failure (Child – Pugh’s score > 12).
- •7.Patient with chronic respiratory disease or use of ventilator at home.
- •8.Patients for whom 72 hours or longer has passed since the attachment of ventilator.
- •10.Patient with clinically findings consistent with diffuse alveolar haemorrhage.
- •11.Patients with mean arterial (blood) pressure < 60 mmHg despite treatment with one or more vasopressor or vasoactive agent.
- •12.Patients who are appropriate to be treated with extracorporeal membrane oxygenation (ECMO) at screening or currently receiving ECMO.
- •13.Patients who were resuscitated after cardio-respiratory arrest.
- •14.Patients with uncontrolled co-morbidities like hypertension, diabetes mellitus etc., as per investigator discretion 15.Patients who are under artificial dialysis at screening.
- •16.Patient documented to have deep venous thrombosis or pulmonary embolism within last 3 months.
- •18.Women of childbearing age who are not using an adequate method of contraception.
- •If the patient is menopausal, it must be documented.
- •19.Pregnancy or breast feeding.
- •20.Patient with HIV infection.
- •21.Patient expected to have hypersensitivity.
结局指标
主要结局
Percent mortality 28 days after administration of BMMSCs
时间窗: 28 days
次要结局
- ICU free days 28 days after administration of BMMSCs(Number of days alive and off ventilatory support at 28 days)
研究者
研究点 (5)
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