您当前的位置: 首页 > 资源详情

Biospace,11月8日,New Phase 3 Analyses Show That a Single Dose of REGEN-COV? (casirivimab and imdevimab) Provides Long-term Protection Against COVID-19

编译者:YUTING发布时间:Nov 14, 2021点击量:45 来源栏目:最新研究

Single dose of REGEN-COV (1,200 mg subcutaneous) reduced the risk of COVID-19 by 81.6% during the pre-specified follow-up period (months 2-8), maintaining the 81.4% risk reduction previously reported during month 1

During the 8-month assessment period there were 0 hospitalizations for COVID-19 in the REGEN-COV group and 6 in the placebo group

The fully human antibodies in REGEN-COV were developed to provide long-lasting protective effects without any artificial mutations or sequences

Regeneron Pharmaceuticals, Inc., (NASDAQ: REGN) today announced additional positive results from a Phase 3 trial jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), which assessed use of a single dose of investigational REGEN-COV® (1,200 mg administered via 4 subcutaneous injections) to prevent COVID-19 in uninfected individuals. The new analyses show REGEN-COV reduced the risk of contracting COVID-19 (i.e., laboratory-confirmed symptomatic SARS-CoV-2 infections) by 81.6% during the pre-specified follow-up period (months 2-8), maintaining the 81.4% risk reduction during the first month after administration, which was previously reported in The New England Journal of Medicine.

"Today's new data demonstrate how a single dose of REGEN-COV can help protect people from COVID-19 for many months after administration," said Myron S. Cohen, M.D., who leads the monoclonal antibody efforts for the NIH-sponsored COVID Prevention Network (CoVPN) and is Director of the Institute for Global Health & Infectious Diseases at the University of North Carolina at Chapel Hill. "These results demonstrate that REGEN-COV has the potential to provide long-lasting immunity from SARS-CoV-2 infection, a result particularly important to those who do not respond to COVID-19 vaccines including people who are immunocompromised."

In results previously published, the trial met its primary endpoint, reducing the risk of COVID-19 (i.e., laboratory-confirmed symptomatic SARS-CoV-2 infections) by 81.4% within 1 month of receiving REGEN-COV (p<0.0001). The new results released today describe a pre-specified analysis for the following 7 months, throughout which an additional 45 symptomatic infections occurred. During this time period, REGEN-COV continued to prevent infection, without requiring additional doses. Compared to placebo (n=842), people who received a single dose of REGEN-COV (n=841) experienced:

81.6% reduced risk of developing COVID-19 during the pre-specified follow-up period, between months 2-8 (7 REGEN-COV, 38 placebo; 95% confidence interval [CI]: 59.8%, 91.6%; nominal p<0.0001).

81.5% reduced risk of developing COVID-19 at any time during the 8 months after receiving REGEN-COV (20 REGEN-COV, 108 placebo; 95% CI: 70.6%,88.4%; nominal p<0.0001).

During the 8-month assessment period, 0 individuals in the REGEN-COV group were hospitalized due to COVID-19, compared to 6 individuals in the placebo group (1 person in the first month; 5 people during months 2-8). There were no deaths due to COVID-19 in any treatment group during the 8-month assessment period, and there were no new safety signals identified for REGEN-COV.

The trial, which was fully enrolled in early 2021, allowed participants to become vaccinated if they wished once the primary efficacy treatment period (month 1) was complete. Vaccination rates during the months 2-8 assessment period were balanced, with 34.5% (n=290) of the REGEN-COV group and 35.2% (n=296) of the placebo group receiving at least 1 COVID-19 vaccine dose by the end of the 8-month assessment period.

提供服务:导出本资源
  1. 1 Nature,11月10日,Initial whole-genome sequencing and analysis of the host genetic contribution to COVID-19 severity and susceptibility
  2. 2 11月10日_研究人员分析宿主基因对COVID-19严重程度和易感性的影响
  3. 3 11月11日_新冠药物Remestemcel-L二期临床的中期分析结果积极
  4. 4 11月11日_CDC呼吁制定通用口罩规定以减少新冠传播
  5. 5 SSRN,2月20日,Dynamics of the Latest 2019 Novel Coronavirus Disease Epidemic in China: A Descriptive Study
  6. 6 SSRN,2月20日,Mental Health Problems and Social Media Exposure During COVID-19 Outbreak
  7. 7 SSRN,2月20日,Evaluating Incidence and Impact Estimates of the Coronavirus Outbreak from Official and Non-Official Chinese Data Sources
  8. 8 SSRN,2月20日,Clinical Characteristics and Treatment of Patients Infected with COVID-19 in Shishou, China
  9. 9 Nature,11月10日,Mobility network models of COVID-19 explain inequities and inform reopening
  10. 10 1月27日_Nature报道中国新型冠状病毒最新研究进展:病毒传播速度有多快?
  1. 1 Medicalxpress,1月17日,Additional antibodies may protect against COVID
  2. 2 Medicalxpress,1月14日,Research team finds new dual benefit mode of action for a drug candidate to fight COVID-19
  3. 3 Medicalxpress,1月13日,WHO recommends two new drugs to treat patients with COVID-19
  4. 4 1月13日_研究发现阻断人类细胞BRD2的产生可防止SARS-CoV-2感染
  5. 5 1月13日_科学家识别出可预防COVID-19严重疾病的人体基因变异
  6. 6 Medicalxpress,1月13日,Preliminary research suggests SARS-CoV-2 virus less infectious within five minutes of exposure to air
  7. 7 Medicalxpress,1月13日,Maternal COVID-19 infection increases risks of preterm birth, low birth weight and stillbirth
  8. 8 Medicalxpress,1月12日,Researchers use artificial intelligence to guide the search for the next SARS-like virus
  9. 9 1月12日_研究人员发现可抑制SARS-CoV-2复制的化合物
  10. 10 1月12日_全球研究揭示儿童严重COVID-19相关风险因素

版权所有@2017中国科学院文献情报中心

制作维护:中国科学院文献情报中心信息系统部地址:北京中关村北四环西路33号邮政编号:100190