CTRI/2021/02/031520已完成2 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Confirmed SARS-CoV-2 infection.
- •2. Age: 18 years old and above.
- •3. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
- •4. Ability to receive treatment by spray into the nasal cavity
- •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
- •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
- •1. Tube feeding or parenteral nutrition.
- •2. 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.
- •3. Uncontrolled diabetes type 2.
- •4. Autoimmune disease.
- •5. Pregnant or lactating women.
- •6. 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.
研究者
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