Immunotherapy of COVID-19 With B-Cell Activating CPI-006 Monoclonal Antibody
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19
研究概览
简要总结
This Phase 1 single-dose, dose-escalation study is an open label trial evaluating the safety of CPI-006, a humanized monoclonal antibody targeting the CD73 cell-surface ectonucleotidase, as immunotherapy for stable hospitalized mild or moderately symptomatic COVID-19 patients with a parallel non-randomized Control Arm for treatment with standard of care only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nasal swab test positive by reverse transcriptase PCR for SARS CoV-2 within past 7 days, and onset of COVID-19 symptoms no more than 10 days prior to the positive test
- •Hospitalized and have stable mild to moderate symptoms of COVID-19
- •Blood oxygen saturation of a minimum of 92% on either no oxygen or up to 5L/min supplemental oxygen
- •Patients with cancer must be in remission or have stable, controlled disease and may be actively receiving drugs or biologics not deemed by the investigator to likely affect immune response.
- •Women must not be of child bearing potential or agree to use contraceptive guidance for 6 weeks
排除标准
- •Patients receiving previous invasive mechanical ventilation or non-invasive ventilation (CPAP, BiPAP) for COVID-19 illness
- •Patients hospitalized >7 days prior to receiving study intervention
- •Other diseases or conditions that are not controlled
- •On drugs or biologics that are immunosuppressive, cytotoxic or immunomodulatory
- •Patients with autoimmune disease must be controlled on non immunosuppressive or immune modifying agents
- •Have received cytotoxic, immunosuppressive or immunomodulatory agents within past 3 months (other than for treatment of COVID-19).
- •Patients receiving experimental therapies that are immunosuppressive
- •Patients receiving non-immuno-suppressive experimental therapies within 7 days prior to receiving CPI-006
- •Patients receiving convalescent plasma within 24 hours prior to receiving CPI-006
- •Patients receiving experimental anti-SARS CoV-2 monoclonal antibodies within past 30 days
研究组 & 干预措施
CPI-006 Dose Escalation
CPI-006 + Standard of Care
干预措施: CPI-006 (Drug)
Control Arm
Standard of Care Only
干预措施: Standard of Care (Other)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19
时间窗: Up to 30 days after dose of CPI-006.
Incidence of adverse events (including serious adverse events and dose limiting toxicities).
Immunoglobulin Anti-SARS CoV-2 Levels
时间窗: Baseline and Day 28.
Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.
次要结局
- Rate of medical procedures(Up to 24 weeks after dose of CPI-006.)
- Negative Nasal Swab Polymerase Chain Reaction (PCR) SARS CoV-2 Viral Tests(Baseline to two consecutive negative nasal swab PCR SARS CoV-2 viral tests (separated by at least 48 hours).)
- Duration of symptoms(Up to 24 weeks after dose of CPI-006.)
- Time to discharge(Up to 24 weeks after dose of CPI-006.)
- Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels(Baseline and visits through Day 28.)