CTRI/2020/10/028277已完成3 期
A Double Blind, Multi-Center, Two- Arm, Randomized, Placebo Controlled, Phase III Clinical Study to Evaluate the Effectiveness and Safety of Thymosin �±-1 (T�±1) as an Add on Treatment to Existing Standard of Care Treatment in Moderate to Severe COVID-19 Patients
Gufic Biosciences0 个研究点目标入组 105 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
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.Male or female of more than or equal to 18 years of age at the time of consent
- •2.Patient who can and willing to provide written Informed Consent
- •3.Patient or patientââ?¬•s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements
- •Inclusion criteria for moderate COVID-19 patients
- •4.Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or any other confirmatory tests
- •5.Patient with pneumonia with no signs of severe disease
- •6.If the patient presents any one of the following features:
- •-Respiratory rate of more than or equal to ââ?¬â?°24 breath per min
- •-SpO2 (oxygen saturation) more than 90 percent to less than or equal to 94 percentage on room air
- •Inclusion criteria for severe COVID-19 patients
- •7.Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or any other confirmatory tests
- •8.If the patient presents any one of the following features:
- •-respiratory distress with a respiratory rate of more than or equal toââ?¬â?°30 breath per min
- •-SpO2 (oxygen saturation) less than or equal toââ?¬â?°90 percentage on room air
- •-PaO2 (arterial blood oxygen partial pressure) or FiO2 (Fraction of Inspired Oxygen) less than or equal toââ?¬â?°200 mmHg (1 mmHgââ?¬â?°equal toââ?¬â?°0.133 kPa)
- •-Patient presents respiratory failure and requires mechanical ventilation support
排除标准
- •1.Patient who has participated in any other clinical trial of an experimental treatment for COVID-19
- •2.Patients with the presence of any pre-existing illness that, in the opinion of the investigator, would place the patient at an unreasonably increased risk through participation in this study.
- •3.Patient who has participated in another trial with an investigational drug within 1 month prior to this trial.
- •4.Female patient who is breast-feeding, pregnant, or intends to become pregnant during the study
- •5.Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
研究者
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