EUCTR2020-002542-16-DE进行中（未招募）1 期
An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19 - Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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. SARS-CoV-2 infection documented by PCR or other nucleic acid test (NAT) within 3 days prior to randomization OR documented by NAT more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection
- •2. Symptomatic COVID-19 disease
- •3. Duration of symptoms attributable to COVID-19 = 12 days
- •4. Requiring inpatient hospital medical care for clinical manifestations of COVID-19 (admission for public health or quarantine only is not included)
- •5. Age = 18 years
- •6. Willingness to abstain from participation in other COVID-19 treatment trials until after study Day 7
- •7. Provision of informed consent by participant
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •1. Prior receipt of SARS-CoV-2 hIVIG or convalescent plasma from a person who recovered from COVID-19 at any time
- •2. Prior receipt of standard IVIG (not hyperimmune to SARS-CoV-2) within 45 days
- •3. Current or predicted imminent (within 24 hours) requirement for any of the following:
- •? Invasive ventilation
- •? Non-invasive ventilation
- •? Extracorporeal membrane oxygenation
- •? Mechanical circulatory support
- •? Continuous vasopressor therapy
- •4. History of allergy to IVIG or plasma products
- •5. History of selective IgA deficiency with documented presence of anti-IgA antibodies
- •6. Any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient
- •? Includes New York Heart Association Class III or IV stage heart failure
- •7. Any of the following thrombotic or procoagulant disorders:
- •? Acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization ? History of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or antiphospholipid syndrome
- •8. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
- •9. Pregnant or nursing women will be excluded from the clinical trial
- •10. Prior receipt of any SARS-CoV-2 monoclonal antibody treatments at any time
研究者
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