A Phase II, Open label 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
- 20
- 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
A Phase II, Open label controlled clinical study designed to evaluate the effect of ArtemiC in patients diagnosed with COVID-19.
The primary outcomes of the study are
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 outcomesof the studyare
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 Unit (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
- Not Applicable
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.
- •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 nasal cavity Cohort 1: 1.10 Patients clinically assigned as moderate [Presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 < 92% range 90-92% on room air, Respiratory Rate more or equal to 24 per minute] 2.Patients with a score of 4 (oxygen by mask or nasal prongs) on the 8- point ordinal scale of clinical status used by WHO at baseline assessment Cohort 2: 1.10 patients clinically assigned as severe (Clinical signs of Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 < 90% on room air) but not critically ill (acute respiratory distress syndrome [ARDS], multi organ failure or septic shock).
- •2.Patients with a score of 5 (Non-invasive ventilation or high flow oxygen) on the 8- point ordinal scale of clinical status used by WHO at baseline assessment.
排除标准
- •Tube feeding or parenteral nutrition.
- •Critically ill patients, defined as those who are candidates for endotracheal intubation and invasive mechanical ventilation and those with ARDS, septic shock or multi-organ failure at baseline.
- •Uncontrolled diabetes type
- •Autoimmune disease.
- •Pregnant or lactating women.
- •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)