CTRI/2021/11/038040尚未招募2 期
A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of FP-025 in Patients With Severe to Critical COVID-19 With Associated Acute Respiratory Distress Syndrome (ARDS)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Is willing to provide informed consent (or has a legally authorized representative [LAR] willing to provide informed consent) and is willing and able (or has an LAR willing and able) to comply with the protocol required therapy, monitoring, and follow-up;
- •2. Is a male or female aged = 18 years;
- •3. Has a COVID-19 diagnosis confirmed by a documented, positive severe acute respiratory syndrome (SARS) CoV-2 reverse transcriptase polymerase chain reaction test (or equivalent test) immediately prior to or during the current hospitalization;
- •4. Is hospitalized with severe to critical COVID 19 within a 72-hour period prior to the Screening Visit
- •and meeting the following characteristics:
- •-Diagnosed with ARDS based on the Berlin criteria as follows:
- •a. Respiratory symptoms developed within 1 week of a known clinical insult or new or worsening respiratory symptoms developed during the past week;
- •b. Chest radiograph or computed tomography scan shows bilateral opacities not fully explained by pleural effusions, lobar or lung collapse, or pulmonary nodules; and
- •c. Respiratory failure is not fully explained by cardiac failure or fluid overload; and
- •-Requiring at least 1 of the following:
- •a.Endotracheal intubation and mechanical ventilation;
- •b. Oxygen delivered by high flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates > 20 L/minute with a fraction of delivered oxygen = 0.5);
- •c. Non invasive positive pressure ventilation; or
- •d. Clinical diagnosis of respiratory failure (ie, the clinical need for 1 of the preceding therapies, but preceding therapies are unable to be administered in the setting of resource limitations).
排除标准
- •1. Is not expected to survive more than 24 hours;
- •2. Is on extracorporeal membrane oxygenation (ECMO) at the Screening Visit;
- •3. Has an underlying clinical condition where, in the opinion of the Investigator, it would be extremely
- •unlikely that the patient would come off ventilation (eg, motor neuron disease, Duchenne muscular
- •dystrophy, or rapidly progressive pulmonary fibrosis);
- •4. Has a known history of idiopathic pulmonary fibrosis or interstitial lung disease as defined by the
- •American Thoracic Society 2018 guidelines
研究者
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