A Phase 2 Randomized, Double-blinded Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Plasma for Early Treatment of COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 223
- 试验地点
- 2
- 主要终点
- Number of Hospitalized Participants Requiring Supplemental Oxygen
研究概览
简要总结
This is a double-blinded, randomized control trial to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as early treatment. Participants will be randomized 2:1 to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody ("anti-SARS-CoV-2 plasma") or control (albumin 5%). This study will investigate the potential of convalescent plasma (CP) to reduce severity of and/or help treat SARS-CoV-2 disease in patients with mild disease.
详细描述
There are no approved therapies for Coronavirus disease 2019 (COVID-19), also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity. Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS). In recent work in China, an open label safety trial of CP in patients with COVID-19 suggested a substantive benefit.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be 18 years of age or older
- •Recent close contact with a person with COVID-19, i.e. last close contact occurred within 7 days of anticipated infusion of study product. It is anticipated that most contacts will be household contacts with extensive interaction. All must meet the CDC criteria for close contacts. This includes healthcare workers at higher risk of developing severe disease.
- •Recent self-reported or documented evidence of infection by nasal swab PCR that is positive for SARS-CoV-2, i.e., nasal sample was collected within 7 days or 10 days of anticipated infusion of study product for those who are asymptomatic or symptomatic, respectively.
- •Evidence of infection by nasal swab PCR that is positive for SARS-CoV-2 at screening visit.
- •May or may not be hospitalized.
- •No symptoms or no more than 5 days of mild symptoms at the time of screening. Mild symptoms (rated by participant as mild and not interfering with normal daily activities) may include:
- •Mild rhinorrhea
- •Mild sore throat or throat irritation
- •Mild nonproductive cough
- •Mild fatigue (able to perform Activities of Daily Living (ADLs))
- •Risk for severe COVID-19 based on a risk score of ≥ 1 Calculated Risk Score of ≥ 1 point, with risk factors based on Center for Disease Control and Prevention (CDC) description
- •Age 65-74: 1 point
- •Age ≥ 75: 2 points
- •Known cardiovascular disease (including hypertension): 1 point
- •Diabetes mellitus: 1 point
- •Pulmonary disease (COPD, moderate to severe asthma, current smoking or other): 1 point
- •Morbid obesity: 1 point
- •Immunocompromised state: 1 point Received a bone marrow or solid organ transplant at any time, received chemotherapy for a malignancy within the past 6 months, has an acquired or congenital immunodeficiency, currently receiving immunosuppressive or immune modulating medications, HIV with non-suppressed viral load and/or cluster of differentiation 4 (CD4+) T cell count <200 cells/mL).
排除标准
- •Receipt of any blood product in past 120 days.
- •Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance.
- •Confirmed or self-reported presumed COVID-19, with symptoms that began more than 5 days prior to enrollment, and SARS-CoV-2 PCR positive sample that was collected more than 7 days prior to anticipated infusion for an asymptomatic participant or more than 10 days prior to anticipated infusion for a patient with mild symptoms at screening.
- •Symptoms consistent with COVID---19 infection that are more than mild (as defined above) at time of screening.
- •Symptoms consistent with COVID---19 infection that are more than mild at time of screening.
- •History of allergic reaction to transfusion blood products
- •Inability to complete infusion of the product within 48 hours after randomization.
- •Resident of a long term or skilled nursing facility
- •Known prior diagnosis of immunoglobulin A (IgA) deficiency
- •Oxygen saturation that is < 95% at the screening visit
- •On supplemental oxygen at time of enrollment
- •Participation in another clinical trial of anti-viral agent(s) for COVID-19
- •Receipt of any COVID-19 vaccine, either as part of a clinical research trial or through routine service delivery.
结局指标
主要结局
Number of Hospitalized Participants Requiring Supplemental Oxygen
时间窗: Up to 28 days
Participants who remained hospitalized and required supplemental oxygen after receiving the study drug.
Number of Non-Hospitalized Participants
时间窗: Up to 28 days
Participants who were discharged from the hospital after receiving the study intervention.
Number of Hospitalized Participants Requiring High-flow Oxygen Therapy or Noninvasive Mechanical Ventilation
时间窗: Up to 28 days
Participants who remained hospitalized and required high-flow oxygen therapy or noninvasive mechanical ventilation after receiving the study intervention.
次要结局
- Rate of Measurable Anti-SARS-CoV-2 Titers(Up to 90 days)
- Rate of SARS-CoV-2 PCR Positivity(Up to 28 days)
- Duration of SARS-CoV-2 PCR Positivity(Up to 28 days)
- Number of In-hospital Mortalities(Up to 28 days)
- Levels of SARS-CoV-2 RNA(Up to 28 days)
研究者
Andrew Eisenberger
Associate Professor of Medicine
Columbia University