A multi-centric, open-label, comparative, randomized, phase 3 trial to evaluate the efficacy and safety of Aviptadil as an add-on treatment to the Standard of Care in acute respiratory distress syndrome.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- Improvement in PaO2/FiO2 ratio.
研究概览
简要总结
Vasoactive Intestinal Peptide (VIP) was awarded an Orphan Drug Designation in 2001 by the USFDA for the treatment of Acute Respiratory Distress Syndrome (ARDS). Aviptadil, a synthetic form of human VIP was awarded Orphan Drug Designation for the treatment of Pulmonary Arterial Hypertension (in 2005 by USFDA), Acute Lung Injury (in 2006 by EMA), and Sarcoidosis (in 2007 by EMA and in 2020 by USFDA). Aviptadil has been studied in respiratory disease conditions like asthma, acute lung injury, pulmonary arterial hypertension, sarcoidosis and idiopathic pulmonary fibrosis. Recent clinical studies conducted in the USA and India have shown encouraging results in ARDS associated with COVID-19 patients in terms of reduction in mortality rate and hospital stay. Aviptadil was approved by DCG(I) in India for the management of ARDS in severe COVID-19 patients. After considering the role of Aviptadil, this trial was designed to evaluate the efficacy and safety of Aviptadil in ARDS patients with diverse etiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with >18 years of age.
- •Patients with ARDS, confirmed by the New Global Definition of ARDS, 2024 based on the following diagnostic criteria.
- •Patients within 7 days from invasion or exacerbation of respiratory symptoms or acute onset of ARDS.
- •Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on High-resolution computed tomography (HRCT).
- •Patients with respiratory failure not fully explained by cardiac failure or fluid overload; If no risk factor for ARDS is identified, hydrostatic edema must be excluded by objective measures (e.g., echo-cardiography).
- •Patients with one of the oxygenation criteria: PaO2/FiO2 ratio ≤ 300mmHg with positive end-expiratory pressure (PEEP) at least 5 cmH2O OR SpO2:FiO2 ≤ 315 (if SpO2 ≤97%) on HFNO with flow of ≥30 L/min or NIV/CPAP with PEEP at least 5 cmH2O.
- •Obtained informed consent for participation in the study from the patients or legally acceptable representative.
排除标准
- •Patients with mechanical ventilation for more than 48 hours prior to ARDS diagnosis.
- •Patients with congestive heart failure.
- •Patients with acute left ventricular failure.
- •Patients with liver failure (Child Pugh grade C).
- •Patients with chronic renal failure requiring renal dialysis therapy.
- •Patients who have burns more than 20% of total body surface area.
- •Patients after resuscitation from cardiac arrest.
- •Patients with a history of hypersensitivity to the anticoagulants.
- •Patients with more than 3 watery stools within 24 hours.
- •Pregnant or lactating women.
- •Decision of the investigator that participation in the study is not in the best interest of the patient or any condition that prevents the safe adherence to the protocol.
结局指标
主要结局
Improvement in PaO2/FiO2 ratio.
时间窗: Baseline and on post-treatment day 1, 2, 3, 4, 5, 6, 7.
次要结局
- Survival rate(Baseline to post-treatment day 7)
- Oxygenation Index(Baseline, post-treatment day 1, 4 and 7)
- Change in Sequential Organ Failure Assessment (SOFA) score(Baseline, post-treatment Day 4 and 7)
- Duration of stay in hospital(baseline to post-treatment day 7)
- Incidences of adverse events
研究者
Dr Bhupesh Dewan
Zuventus Healthcare Limited