Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- clinical improvement
研究概览
简要总结
It is clear now that SARS-CoV-2 could use angiotensin-converting enzyme 2 (ACE2), the same receptor as SARS-CoV Transmembrane protease serine type 2 (TMPRSS2), a protease belonging to the type II transmembrane serine protease family, cleaves the coronavirus spike protein Serine proteases are inhibited by a diverse group of inhibitors, The best-studied serpins are antithrombin and alpha 1-antitrypsin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive RT-PCR) assay for SARS-CoV-2
- •Age >18 years
- •Hospitalized
- •Able to give informed consent
排除标准
- •Known allergy to AAT
- •imminent death within next 24 hours
研究组 & 干预措施
alpha one antitrypsin group
- we will give 8 ml of intravenous alpha one antitrypsin (alpha1-proteinase inhibitor (AATD)Glassia 50 ml) add to 2cm of normal saline solution as nebulizer every 12 hours for 5 days
干预措施: alpha one antitrypsin inhalation (Drug)
placebo group
we will give 8 ml of normal saline as nebulizer every 12 hours for 5 days
干预措施: alpha one antitrypsin inhalation (Drug)
结局指标
主要结局
clinical improvement
时间窗: we will follow the patient daily starting from the day 0 which is the first day of giving drug for 3 weeks or till clinical improvement and discharge from the hospital or till death whichever comes first.
Time to clinical improvement, from the point of randomization to two-point improvement on a seven-point ordinal scale or discharged alive from hospital, whichever comes first. Ordinal Scale - 1, Ambulatory with normal activities; 2, Ambulatory with limitation of normal activities; 3, not requiring supplemental oxygen; 4, requiring supplemental oxygen by mask or nasal prongs; 5, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, requiring ECMO, invasive mechanical ventilation, or both; and 7, death
次要结局
未报告次要终点
研究者
mohamed mahmoud mohamed othman
assistant consultant gastroenterology
Ministry of Health, Saudi Arabia