A Phase II, controlled clinical study designed to evaluate the effect of ArtemiC in patients diagnosed with COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of ≤ 2 Maintained for 24 Hours in comparison to routine treatment
研究概览
简要总结
This Study is A Phase II, controlled clinical study designed to evaluate the effect of ArtemiC in patients diagnosed with COVID-19.
The primary outcomes:
Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of
Percentage of participants with definite or probable drug related adverse events
The secondary outcomes:
Time until negative PCR
Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms
COVID-19 related survival
Incidence and duration of mechanical ventilation
Incidence of Intensive Care Init (ICU) stay
Duration of ICU stay
Duration of time on supplemental oxygen
Additional Data will be recorded to complete the Core Set of Outcomes
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed SARS-CoV-2 infection.
- •Hospitalized patient with COVID-19 of moderate stable or worsening severity not requiring ICU admission, and on the other hand not experiencing clinical improvement under ongoing standard care.
- •Age: 18 years old and above.
- •Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
- •Ability to receive treatment by spray into the oral cavity.
排除标准
- •Tube feeding or parenteral nutrition.
- •Oxygen requirements beyond use of nozzles or simple mask as per score 4
- •Respiratory decompensation requiring mechanical ventilation.
- •Uncontrolled diabetes type
- •Autoimmune disease.
- •Pregnant or lactating women.
- •Need for admission to ICU in the course of the present hospitalization at any time prior to completion of the recruitment to the study.
- •Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.
结局指标
主要结局
1.Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of ≤ 2 Maintained for 24 Hours in comparison to routine treatment
时间窗: 15 Days
2.Percentage of participants with definite or probable drug related adverse events
时间窗: 15 Days
次要结局
- 1.Time until negative PCR(2. Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms)