CTRI/2021/09/036828已完成2 期
A Randomized, Double-Blinded, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Inhaled Ampion in Adults with Respiratory Distress due to COVID-19.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Percentage of participants with a successful outcome (life) or unsuccessful outcome (death) by Day 28.
研究概览
简要总结
The severe acute respiratory syndromecoronavirus 2 (SARS-CoV-2) has resulted in the pandemic spread of coronavirusdisease 2019 (COVID-19), which has a high rate of infection, has a high rate ofhospitalization, has overwhelmed healthcare systems, and can be fatal.
Ampion is the low molecular weightfiltrate of human serum albumin with the in vitro ability to modulateinflammatory cytokine levels. Ampion has the potential to improve clinicaloutcomes for COVID-19 patients by reducing inflammatory cytokines correlatedwith the disease and respiratory complications, such as Acute Lung Injury (ALI)and Acute Respiratory Distress Syndrome (ARDS).
This study aims to evaluate the effects ofAmpion on mortality and clinical outcomes in patients with respiratory distressdue to COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female, ≥ 18 years old
- •Diagnosed with SARS-CoV2, as confirmed using a standard RT-PCT assay or an equivalent test.
- •Baseline severity categorization of severe or critical COVID-19 infection per FDA Guidance for developing drugs and biological products for COVID-19 (February 2021): a) Severe COVID-19: • Symptoms suggestive of severe systemic illness with COVID-19, which could include shortness of breath or respiratory distress.
- •â€¢ Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥ 30 per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at or PaO2/FiO2 <
- •b) Critical COVID-19: • Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered • Non-invasive mechanical or endotracheal mechanical ventilation via reinforced cannula at flow rates > 20 L/min with fraction of oxygen ≥ 0.5)
- •Informed consent obtained from the patient or the patients legal representative.
排除标准
- •1.As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study and/or progression to death is imminent and inevitable irrespective of the provision of treatments.
- •Clinical diagnosis of respiratory failure requiring ECMO and/or therapy is not available due to limitation.
- •Shock defined by systolic blood pressure <90 mm Hg, or diastolic blood pressure <60 mm Hg or requiring vasopressors.
- •Multi-organ dysfunction/failure.
- •Patient has severe chronic obstructive or restrictive pulmonary disease (COPD) (as defined by prior pulmonary function tests), chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.).
- •Patient has chronic conditions requiring chemotherapy or immunosuppressive medication 7.A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (N- acetyltryptophan, sodium caprylate).
- •Prolonged QT interval.
- •Patient has known pregnancy or is currently breastfeeding.
- •Patient planning to become pregnant, or father a child, during the treatment and follow-up period and/or is not willing to remain abstinent or use contraception.
- •Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access, emergency, or compassionate use), or participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s).
结局指标
主要结局
Percentage of participants with a successful outcome (life) or unsuccessful outcome (death) by Day 28.
时间窗: To be assessed by Day 28
次要结局
- Change in ordinal scale(To be assessed from baseline through Day 5.)
- Change in NEWS2 score(Modulation of cytokine levels)
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(To be assessed from baseline to day 60)
- Hospital length of stay (LOS)(From admission (baseline) to discharge)
- Change in baseline in oxygen use, blood oxygen saturation, and oxygen flow rate(To be assessed from baseline through Day 5.)
- Percentage of participants who progress to respiratory failure (i.e., need for mechanical ventilation, ECMO, non-invasive ventilation)(To be assessed by day 28.)
- Percentage of participants who require Intensive Care Unit (ICU)(To be assessed by day 28)
研究者
研究点 (10)
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