NCT04666441已完成2 期
A Phase 2 Study to Assess the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Outpatients With SARS-CoV-2 Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,149
- 试验地点
- 1
- 主要终点
- Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples
研究概览
简要总结
The primary objective of the study is to assess the virologic efficacy of REGN10933+REGN10987 across different intravenous and subcutaneous doses compared to placebo.
The secondary objectives of the study are:
- To evaluate additional indicators of virologic efficacy of REGN10933+REGN10987 compared to placebo
- To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
- To assess the concentrations of REGN10933 and REGN10987 in serum over time
- To assess the immunogenicity of REGN10933 and REGN10987
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •Has SARS-CoV-2-positive diagnostic test from a sample collected ≤72 hours prior to randomization, as defined by the protocol
- •Low-risk symptomatic patient: Has symptoms consistent with COVID-19 (as determined by the investigator) with onset ≤7 days before randomization, and meets all of the following 8 criteria:
- •No obesity, with obesity defined as BMI ≥30 kg/m2
- •Does not have cardiovascular disease or hypertension
- •Does not have chronic lung disease or asthma
- •Does not have type 1 or type 2 diabetes mellitus
- •Does not have chronic kidney disease, with or without dialysis
- •Does not have chronic liver disease
- •Is not pregnant or
- •Asymptomatic patient: Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time <2 months prior to randomization
- •Maintains O2 saturation ≥93% on room air
排除标准
- •Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
- •Has a known positive SARS-CoV-2 serologic test
- •Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected >72 hours prior to randomization
- •Is immunosuppressed, based on investigator's assessment
- •Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
- •Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, (eg, bamlanivimab), IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)
- •Prior use (prior to randomization), current use (at randomization), or planned use (within time period given per CDC guidance but no sooner than 22 days of study drug administration) of any authorized or approved vaccine for COVID-19
- •Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test
- •Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational vaccine for COVID-19
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
IV Dose 1
Experimental
Combination therapy intravenous (IV) single dose
干预措施: REGN10933+REGN10987 combination therapy (Drug)
IV Dose 2
Experimental
Combination therapy IV single dose
干预措施: REGN10933+REGN10987 combination therapy (Drug)
IV Dose 3
Experimental
Combination therapy IV single dose
干预措施: REGN10933+REGN10987 combination therapy (Drug)
IV Dose 4
Experimental
Combination therapy IV single dose
干预措施: REGN10933+REGN10987 combination therapy (Drug)
Placebo IV Dose
Experimental
Matching placebo IV single dose
干预措施: Placebo (Drug)
SC Dose 1
Experimental
Combination therapy subcutaneous (SC) single dose
干预措施: REGN10933+REGN10987 combination therapy (Drug)
SC Dose 2
Experimental
Combination therapy SC single dose
干预措施: REGN10933+REGN10987 combination therapy (Drug)
Placebo SC Dose
Experimental
Matching placebo SC single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples
时间窗: Day 1 to Day 7
Time-weighted average daily change from Day 1 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
次要结局
- Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987(Through day 120)
- Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)(Through day 29)
- Number of Participants With Hypersensitivity Reactions Grade 2 or Above(Through day 29)
- Concentration of REGN10933 in Serum(Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose)
- Time-Weighted Average Daily Change From Day 1 in Viral Load(Day 1 to Day 5)
- Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline(Day 1 to Day 5)
- Number of Participants With High Viral Load(Day 1, Day 3, Day 5, Day 7, Day 15, Day 22)
- Number of Participants With Viral Loads Below the Limit of Detection(Day 1, Day 3, Day 5, Day 7, Day 15, Day 22)
- Number of Participants With Viral Loads Below the Lower Limit of Quantification(Day 1, Day 3, Day 5, Day 7, Day 15, Day 22)
- Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples(Day 3, Day 5, Day 7, Day 15, Day 22)
- Number of Participants With Infusion-Related Reactions Grade 2 or Above(Through day 4)
- Number of Participants With Injection-Site Reactions Grade 3 or Above(Through day 4)
- Concentration of REGN10987 in Serum(Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose)
- Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933(Through day 120)
- Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933(Through day 120)
- Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987(Through day 120)
研究者
研究点 (1)
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