A Randomized, Double-blind, Placebo-controled, Phase 2a Trial Evaluating the Safety and Initial Efficacy of Resomelagon in Patients With Dengue Infection
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Evaluate safety of Resomelagon in Dengue patients
研究概览
简要总结
The goal of this clinical trial is to understand if Resomelagon can treat adult patients with Dengue virus infection. The main questions the investigators aim to answer are:
Is Resomelagon safe to use in patients with Dengue? Is Resomelagon able to reduce the duration of illness? (defined by clinical and laboratory criteria) Participants will be allocated to Resomelagon or placebo groups in this study and asked to take the medication and submitted to blood tests.
详细描述
Complications of dengue infection follows the peak of viremia and are associated with increased activation of the immune response. Proof-of-concept studies in animal models of dengue infection have shown that blocking certain aspects of the inflammatory response or the administration of pro-resolving molecules is beneficial in experimental dengue. In these experiments, the administration of certain anti-inflammatory or pro-resolution molecules decreases disease severity and aspects of the inflammatory response, including changes in vascular permeability. We have previously shown that treatment with RESOMELAGON decreased lung inflammation and outcome in animal models of beta coronavirus infection (including by SARS-CoV-2) and decreased disease severity in COVID-19 patients, even in the presence of glucocorticoid therapy. Preclinical experiments also showed that RESOMELAGON decreased disease severity in an animal model of dengue infection and decreased cytokine release by human PBMC infected with dengue virus. RESOMELAGON is safe in healthy individuals, those with rheumatoid arthritis, and patients with COVID-19. This is a placebo controlled, randomized, double-blinded clinical trial evaluating the safety and efficacy of Resomelagon in patients with acute dengue infection.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 18 to 65 years old;
- •Able to understand study procedures and give informed consent;
- •Presents with more than 36 and less than 84h since symptoms onset;
- •Symptoms compatible with dengue infection (fever, myalgia, arthralgia, headache or conjunctivitis) with positive antigen test or polymerase chain reaction test.
排除标准
- •Has any comorbidity which is perceived as significant by the investigator;
- •Significant laboratory abnormalities discovered at triage: Hemoglobin <10g/dL; Platelet count < 50.000/microL; alanine transaminase > 3x upper limit of normal; Total bilirubin >1,5 x upper limit of normal; glomerular filtration rate < 60mls/min/1,73m2;
- •Contraindications or known hypersensitivity to Resomelagon;
- •Presents as dengue with warning signs or severe dengue at inclusion;
- •Currently participating in another drug clinical trial;
- •Clinical evidence of another infection that might explain current symptoms;
- •Pregnant women or women actively trying to achieve pregnancy.
研究组 & 干预措施
Placebo
Placebo plus standard treatment
干预措施: Standard Treatment (Other)
Resomelagon
Resomelagon, 100mg, orally, once daily plus standard treatment
干预措施: Resomelagon (Drug)
Resomelagon
Resomelagon, 100mg, orally, once daily plus standard treatment
干预措施: Standard Treatment (Other)
Placebo
Placebo plus standard treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate safety of Resomelagon in Dengue patients
时间窗: 28 days
Incidence of clinical or laboratory adverse events. All symptoms, illness and laboratory abnormalities will be graded by the investigators in accordance to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events graded 3 or more in severity will be registered. Serious adverse events will be reported and registered. Incidence of adverse events will be compared between placebo and intervention groups.
Efficacy of Resomelagon in decreasing illness duration
时间窗: 10 days
Time to resolution of illness as defined by a composite outcome: Patient afebrile for 48 hours without paracetamol (or other drugs to treat fever) ingestion; Rising platelet counts of \>20% of the lowest, or normal platelet counts if the patient did not have thrombocytopenia, following two consecutive measurements from the lowest platelet count Haematocrit stabilized or return to the normal hematocrit for age \& sex, following two consecutive measurements Absence of bleeding or significant vomiting for 48h.
次要结局
- Efficacy of Resomelagon in reducing illness Severity(10 days)
- Efficacy of Resomelagon in reducing plasma leakage(10 days)
- Efficacy of Resomelagon in reducing dengue hospitalization or prolonged observation in the Emergency department(10 days)
研究者
Mauro Martins Teixeira
Pricipal Investigator
Federal University of Minas Gerais