A Randomized, Controlled, Open Label, Multicentre, Two Arm, Two Dosage, Phase II StudyAssessing the Efficacy and Safety of Intravenous Administration of Adult Human Bone MarrowDerived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells in Patients with AcuteRespiratory Distress Syndrome Caused by Pneumonia due to COVID-19

ICMR3 个研究点分布在 1 个国家目标入组 40 人开始时间: 2020年10月14日最近更新: 2021年12月3日

试验速览

阶段: 2 期
状态: Other
发起方
入组人数: 40
试验地点: 3
主要终点: The primary efficacy endpoints are:

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a Randomized, Controlled, Open Label, Multicentre, Two Arm, Two dosage, Phase II Study Assessing the Efficacy and Safety of Intravenous Administration of Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells in Patients with Acute Respiratory Distress Syndrome (ARDS) Caused by Pneumonia due to Coronavirus Disease 2019 (COVID-19).

研究设计

研究类型: Interventional
分配方式: Stratified randomization
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

•Patients must satisfy all of the following criteria to be included in the study:
•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) assay.
•Informed consent by the patient or his/her legal representative in case the patient is not capable of giving the consent.
•Patients diagnosed with COVID-19 pneumonia causing moderate and severe ARDS as per the Berlin ARDS definition.
•Respiratory failure within one week of a known insult or new and/or worsening respiratory symptoms b.
•Respiratory failure not fully explained by cardiac function or volume overload c.
•Moderate to severe hypoxemia must be present, defined as the ratio of PaO2/FiO2 on at least PEEP 5cmH2O: i Moderate ARDS: PaO2/FiO2 >100 mmHg and ?200 mmHg, on ventilator settings that include PEEP ?5 cm H2O OR ii Severe ARDS: PaO2/FiO2 ?100 mmHg on ventilator settings that include PEEP ?5 cm H2O d.
•Bilateral opacities in chest X-ray or CT scan.
•Patients requiring mechanical ventilatory support.
•Patients who can start receiving BMMSCs within 72 hours (3 days) after the diagnosis of ARDS.

排除标准

•Patients may not be selected if any of the following criteria are present
•Any other cause of ARDS not attributable to SARS-CoV
•Patients whose life expectancy is < 6 months because of other causes other than the respiratory failure.
•Presence of any active malignancy.
•Any end stage organ disease as assessed by investigator which may possibly affects the safety of the study drug.
•Patient with history of any stem cell transplant in the past.
•Moderate to severe liver failure (Child â€“ Pughâ€™s score > 12).
•Patient with chronic respiratory disease or use of home oxygen therapy or use of ventilator at home.
•Patients for whom one week or longer has passed since the attachment of ventilator.
•Patient with pulmonary transplant or having history of lung lobectomy.
•Patient with clinically findings consistent with diffuse alveolar haemorrhage.
•Patients with mean arterial (blood)pressure
•Patients who are appropriate to be treated with extracorporeal membrane oxygenation (ECMO) at screening or currently receiving ECMO.
•Patients who were resuscitated after cardio-respiratory arrest.
•Patients with uncontrolled co-morbidities like hypertension,diabetes mellitus etc., as per investigator discretion
•Patients who are under artificial dialysis at screening.
•Patient documented to have deep venous thrombosis or pulmonary embolism within last 3 months.
•Patients with a history of myocardial infarction within 6 months before screening.
•Women of childbearing age who are not using an adequate method of contraception.
•If the patient is menopausal, it must be documented.
•Pregnancy or breast feeding.
•Patient with HIV infection.