EUCTR2020-005015-40-SK进行中（未招募）1 期
A multicentre, phase III, double-blind, randomised, parallel, placebo-controlled trial to assess efficacy and safety of early administration of Ivermectin during 3 consecutive days to prevent SARS CoV-2 (COVID-19) hospitalisation in adults older than 50 years of age - Ivermectin to prevent SARS-CoV-2 (COVID-19) hospitalisation in subjects over 50
Chemo Research S.L.0 个研究点目标入组 832 人开始时间: 2021年3月25日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 832
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 adult > 50 years of age
- •2.SARS-CoV-2 infection diagnosed either through a rapid antigen-based test or an RNA based reverse-transcription polymerase chain reaction (RT-PCR) diagnostic test performed in nasopharyngeal sample
- •3.Onset of COVID-19 symptoms < 120 hours prior to screening (Visit 1.1)
- •4.Written informed consent
- •5.For females of childbearing potential only: They must declare that they did not intend to become pregnant in the last month prior to screening and they do not intend to become pregnant for one month following the last IP administration. For males who have partners of childbearing potential: Willing to use condoms until 3 months after last IP intake.
- •6.Negative result for urine pregnancy test (women of childbearing potential only)
- •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 208
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 624
排除标准
- •1.Intake of Ivermectin within 30 days before screening (Visit 1.1)
- •2.Routine intake of antivirals, including antiretroviral treatment
- •3.Allergy, hypersensitivity or contraindication to Ivermectin, metabolites or excipients
- •4.Subjects with symptoms of disease severity (dyspnoea, SpO2 = 94%)
- •5.Subjects requiring hospitalisation for any reason
- •6.Epidemiological risk or suspicion of being infected by Loa loa or other filariases
- •7.Previous enrolment in this trial or participation in any other drug investigational trial within the past 30 days (or five half-lives of investigational product [IP] whichever is longer) prior to screening (Visit 1.1)
- •8.Weight < 50 kg
- •9.Pregnancy or lactation
- •10.Inability to take oral medications
- •11.At least one of the following acute/chronic disease or deficiency:
- •a.History of bone marrow transplant or haematopoietic systems diseases
- •b.Moderate or severe liver disease (Child Pugh score = B or ALT [alanine transaminase] or AST [aspartate transaminase] > 3 times upper limit as determined at screening (Visit 1.2), severe cholestasis, cirrhosis or severe hepatic failure
- •c.Transplanted patient under immunosuppressive treatment, disease that may need immunosuppressive treatments or other medical conditions that under the judgement of investigator would not benefit the patient to be included (including but not limited to psoriasis, G6PD (glucose-6-phosphate dehydrogenase) deficiency, porphyria, history of diverticulosis, seizure disorder, concurrent malignancy requiring chemotherapy, ongoing skin infection (e.g. pyodermitis) or evidence of current tuberculosis including latent untreated tuberculosis)
- •d.Ophthalmological or recent/ongoing neurological diseases
- •12.Active cardiac disease or a history of cardiac dysfunction including any of the following:
- •a.History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to screening
- •b.History of congestive heart failure (New York Heart Association functional classification III-IV)
- •13.Concomitant use of barbiturates, sodium oxybate, valproic acid or warfarin
- •14.Laboratory abnormalities relevant for the trial, including but not limited to: neutropenia < 500/mm3, thrombocytopenia < 100 000/mm3
- •15.Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the subject because of participation in the study, affect the ability of the subject to participate in the study or impair interpretation of the study data
- •16.Employees of the investigator or clinical trial site, with direct involvement in the proposed trial or other studies under the direction of that investigator or clinical trial site, as well as family members of the employees or the principal investigator
- •17.Persons committed to an institution by virtue of an order issued either by the judicial or other authorities
研究者
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