EUCTR2021-001663-24-DK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 Outpatients in Early Stages of COVID-19 - Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 820
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. Clinical risk based on age = 55 years or an adult (age = 18 years) with an immunosuppressed condition.
- •2. Positive test for SARS-CoV-2 within =5 days (if >1 test, the first positive is within =5 days). Tests may include an institutional-based nucleic acid amplification test (NAAT), or any protocol-approved rapid test.
- •3. Within =5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection.
- •4. Agrees to not participate in another clinical trial for the treatment or management of SARS-CoV-2 infection through Day 7, or until hospitalized or significant disease progression if prior to Day 7 (defined by ordinal category 4 or 5).
- •5. Participant provides written informed consent prior to study procedures, and understands and agrees to adhere to planned study procedures through Day 28.
- •Information on which patient populations may benefit most from passive immune strategies targeting SARS-CoV-2 are limited. However, patients with impaired immune responses, whether from an underlying condition or the result of medical treatments, may have a delayed and/or reduced endogenous antibody response during COVID-19.
- •Ongoing immunosuppressive condition or immunosuppressive treatment, includes:
- •Steroids equivalent to prednisone > 10 mg/day for at least the last 28 days
- •Rheumatologic or autoimmune disorder treated with a biologic or non-biologic immunosuppressive therapy
- •Antirejection medicine after solid organ or stem cell transplantation
- •Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the last 12 months
- •Primary or acquired severe B- or T-lymphocyte immune dysfunction
- •HIV infection
- •Splenectomy or functional asplenia
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Asymptomatic and had prior symptoms from the current infection that have now resolved (for >24 hours).
- •2. Asymptomatic and has received a vaccination for COVID-19 (=1 dose).
- •3. Undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes).
- •4. Evidence of pneumonia and/or hypoxia due to COVID-19 (NOTE: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level).
- •5. Prior receipt of immunoglobulin product or passive immune therapy for SARS-CoV-2 in the past 90 days (i.e., convalescent plasma, SARS-CoV-2 monoclonal antibodies, or any IVIG).
- •6. Any of the following thrombotic or procoagulant conditions or disorders:
- •acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization.
- •prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin III, protein C, or protein S.
- •7. History of hypersensitivity to blood, plasma or IVIG excipients.
- •8. Known IgA deficiency or anti-IgA antibodies.
- •9. Medical conditions for which receipt of a 300 mL volume of IV fluid from study treatment may pose specific risk to the patient (e.g., decompensated congestive heart failure).
- •10. In the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.
研究者
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