NCT05226533终止2 期
A Phase 2, Double Blind, Randomized, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of DWRX2003 in Combination With Remdesivir Following Intramuscular Administration in Moderate-Severe COVID-19 Patients
Daewoong Pharmaceutical Co. LTD.3 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年3月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 3
- 主要终点
- The proportion of subjects requiring mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) till day 14.
研究概览
简要总结
Safety and efficacy of DWRX2003 combination with Remdesivir in moderate to severe COVID-19 patients will be confirmed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at time of signing the Informed Consent Form (ICF).
- •SARS-CoV-2 infection documented by RT-PCR within 7 days prior to randomization.
- •Hospitalized patients who meet the criteria of moderate or severe COVID-
- •Patients who are not pregnant, based on urine pregnancy test during screening, and randomization.
- •Female patients of childbearing potential practice effective contraception during the study and be willing and able to continue contraception for 60 days after their dose of study treatment.
- •Male patient and/or Female patient's partner agree to use condoms or should have undergone vasectomy or spermicide in addition to female contraception for additional protection against conception for 60 days after their dose of study treatment.
- •Patients who are anticipated to available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.
- •Patients who agree to give written informed consent and are willing to participate in the study.
排除标准
- •Patients with BMI ≥30 and/or body weight < 40kg
- •Patients receiving or who have received antiviral therapy and antiretroviral therapy within 28 days prior to the screening visit.
- •Patients who cannot be administered intramuscularly to bilateral ventro-gluteal area.
- •Patients with uncontrolled respiratory disease other than COVID-19 pneumonia (i.e. COPD, asthma, cystic fibrosis, etc.)
- •Patients who have active malignancy, history of active malignancy or chemotherapy within 1 year from the screening.
研究组 & 干预措施
Niclosamide 432mg
Experimental
Niclosamide 432mg (intramuscular injection) + Remdesivir
干预措施: DWRX2003 (Drug)
Niclosamide 960mg
Experimental
Niclosamide 960mg (intramuscular injection) + Remdesivir
干预措施: DWRX2003 (Drug)
Placebo
Placebo Comparator
Placebo (intramuscular injection) + Remdesivir
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of subjects requiring mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) till day 14.
时间窗: day 14
mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) until day 14.
次要结局
未报告次要终点
研究者
研究点 (3)
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