A Phase 1/2 Prospective Randomized Placebo Controlled Study to Assess the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) Administered Sublingual and in Inhalation Concomitantly With BAT (Best Available Care) as Compared to Placebo and BAT for the Treatment of Moderate to Severe COVID-19 Patients.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- Change of Severity rating of Disease using an 8-point ordinal scale on days 7, 14, 21, measured as improvement greater than or equal to 1 point from baseline score.
研究概览
简要总结
This is a phase I/II study with Amorphous Calcium Carbonate (ACC) administered sublingual and in Inhalation concomitantly with BAT (Best Available Care) as Compared to Placebo and BAT for the treatment of Moderate to Severe COVID-19 patients. The purpose of this study is to assess the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC).
详细描述
This study includes two parts:
Part 1 - A training period of a single arm active treatment open label, to assess the optimal method of study drug administration, as well as the safety of the combined administration, on 5 patients.
Following DSMB review of the data collected in part 1 and the DSMB approval to proceed to next part, part 2 will be initiated.
Part 2 - A randomized (1:1) placebo controlled 2 arms study. Additional 95 patients will be recruited to this arm.
Patients who are hospitalized due to moderate or severe COVID-19 will be recruited to this study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females of age ≥ 18 years and ≤ 80 years
- •Signed an Informed Consent
- •Agree to undergo blood tests as per protocol
- •Diagnosed with COVID-19
- •Evidence of lung involvement (by chest X rays or lung US)
- •May or may not need for Supplemental Oxygen at enrollment
- •Hospitalized
排除标准
- •Pregnant or breast-feeding females
- •Patients with non-COVID19 related Pneumonia
- •Any pulmonary disease not related to COVID19
- •Tracheostomy
- •High flow oxygen or non-invasive ventilation (Bipap) or Mechanical ventilation
- •Hypercalcemia defined as calcium or corrected calcium > 10.5mg/dL
- •Hyperphosphatemia defined as > 4.5mg/dL
- •Urine calcium to creatinine ratio >0.14
- •Participating in another clinical study
研究组 & 干预措施
AMOR 18 Powder & Inhalation
AMOR_inhaled Double Pack- Each kit contains two tubes that after mixing result with 1.14 % ACC in 10 ml suspension.
AMOR_powder- ACC in a dry powder (up to 2000mg Calcium/day sublingually).
干预措施: AMOR 18 Powder & Inhalation (Drug)
Placebo
Placebo_Inhaled Double Pack - Each kit contains two tubes of saline at different volumes (similar to investigational product) after mixing the results remains saline at a final volume of 10ml.
Placebo_Powder: Each sachet contains powder at the same particle size and weight as the powder of the investigational product.
干预措施: Placebo (Drug)
结局指标
主要结局
Change of Severity rating of Disease using an 8-point ordinal scale on days 7, 14, 21, measured as improvement greater than or equal to 1 point from baseline score.
时间窗: Treatment Day 1 to Day 21 or discharge from hospital, the earliest.
Ordinal 8 points scale: 1. Not hospitalized and no limitations of activities. 2. Not hospitalized, with limitation of activities, home oxygen requirement, or both. 3. Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedical reasons). 4. Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related to Covid-19 or to other medical conditions). 5. Hospitalized, requiring any supplemental oxygen. 6. Hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices. 7. Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 8. Death.
次要结局
- Duration of Oxygen Supplementation(Treatment Day 1 to treatment day 21 or discharge, whichever comes first.)
- Frequency and severity of adverse events(Screening to End of treatment day 21 or discharge, whichever comes first.)
- % of death(Treatment Day 1 to treatment day 21 or discharge, whichever comes first.)
- Number and percent of patients with hypercalcemia(Treatment days 4, 7, 11, 17 and 21.)
- Duration of Hospital stay(Date of hospitalization to treatment day 21 or discharge, whichever comes first.)
- Duration of ICU stay(Treatment Day 1 to treatment day 21 or discharge, whichever comes first.)
- Duration of Mechanical Ventilation Use(Treatment Day 1 to treatment day 21 or discharge, whichever comes first.)
- Duration of No Oxygen use(Treatment Day 1 to treatment day 21 or discharge, whichever comes first.)
- % of patients to meet ordinal scale of 3 or less(Treatment Day 1 to treatment day 21 or discharge, whichever comes first.)