EUCTR2020-002091-12-BG进行中（未招募）1 期
Multicenter, randomized, double-blind, placebo-controlled study investigating efficacy, safety and tolerability of ivermectin HUVE-19 in patients with proven SARS-CoV-2 infection (COVID-19) and manifested clinical symptoms.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female patients at least 18 years old
- •2.Signed informed consent
- •3.Admitted to hospital for treatment of COVID -19. The hospitalization must be for medical and not for social reasons.
- •4.Patient within 7 days from symptom onset and within 72 hours after laboratory diagnosis (SARS-CoV-2 RT-PCR)
- •5.Mild to Moderate COVID-19 disease defined as clinical status category 3 or 4 on the WHO 9-point ordinal scale
- •Hospitalized, no oxygen treatment
- •Oxygen by mask or nasal prongs
- •6.Presence of at least 1 symptom characteristic for COVID-19 disease, e.g. fever, cough, sore throat, myalgia, fatigue, GI disorders, skin lesions etc
- •7.In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Critical patients with expected survival time < 72 hours
- •2.Presence of respiratory failure, shock, and/or combined failure of other organs that requires ICU monitoring
- •3.Participation in the trial is not in the patient`s best interest based on the judgement of the Investigator
- •4.Presence of the following laboratory values at screening
- •White blood cell count <1,5X109/L
- •Platelet count< 100000 mm3(<100 X109/L)
- •Total bilirubin>2 X upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) or gamma glutamyl transferase (GGT) > 3 X ULN
- •5.Clinical suspicion for a bacterial superinfection at screening
- •6.Allergic or hypersensitive to the IMP or any of the ingredients
- •7.Patients who cannot take drugs orally, or have severe gastro-intestinal disorders, extensive bowel resection or bowel obstruction.
- •8.Previous (in the past 3 months) or concurrent use of any other Investigational product (IP)
- •9.Use of the prohibited medications during the treatment with IP, as defined in the protocol;
- •10.Patients with end stage liver disease (Child Pugh C score)
- •11.History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class III or 4)
- •12.Presence of acute stroke at screening or a history of acute stroke within the last 6 months.
- •13.Pregnant or breastfeeding
- •14.Legal incapacity, limited legal capacity, or any other condition that makes the patient unable to provide consent for the trial.
- •15.Patients who are institutionalized due to judicial order.
- •16.An employee or immediate relative of the Investigator or Sponsor.
- •17.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including asthma and COPD), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or gastro-intestinal disorder, that according to Investigator could jeopardize the safety of the patient, or the integrity of the study
研究者
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