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Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19.
Levin, Myron J; Ustianowski, Andrew; De Wit, Stéphane; Launay, Odile; Avila, Miles; Templeton, Alison; Yuan, Yuan; Seegobin, Seth; Ellery, Adam; Levinson, Dennis J; Ambery, Philip; Arends, Rosalinda H; Beavon, Rohini; Dey, Kanika; Garbes, Pedro; Kelly, Elizabeth J; Koh, Gavin C K W; Near, Karen A; Padilla, Kelly W; Psachoulia, Konstantina; Sharbaugh, Audrey; Streicher, Katie; Pangalos, Menelas N; Esser, Mark T.
  • Levin MJ; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Ustianowski A; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • De Wit S; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Launay O; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Avila M; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Templeton A; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Yuan Y; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Seegobin S; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Ellery A; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Levinson DJ; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Ambery P; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Arends RH; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Beavon R; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Dey K; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Garbes P; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Kelly EJ; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Koh GCKW; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Near KA; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Padilla KW; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Psachoulia K; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Sharbaugh A; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Streicher K; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Pangalos MN; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
  • Esser MT; From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge,
N Engl J Med ; 386(23): 2188-2200, 2022 06 09.
Article in English | MEDLINE | ID: covidwho-1805743
ABSTRACT

BACKGROUND:

The monoclonal-antibody combination AZD7442 is composed of tixagevimab and cilgavimab, two neutralizing antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that have an extended half-life and have been shown to have prophylactic and therapeutic effects in animal models. Pharmacokinetic data in humans indicate that AZD7442 has an extended half-life of approximately 90 days.

METHODS:

In an ongoing phase 3 trial, we enrolled adults (≥18 years of age) who had an increased risk of an inadequate response to vaccination against coronavirus disease 2019 (Covid-19), an increased risk of exposure to SARS-CoV-2, or both. Participants were randomly assigned in a 21 ratio to receive a single dose (two consecutive intramuscular injections, one containing tixagevimab and the other containing cilgavimab) of either 300 mg of AZD7442 or saline placebo, and they were followed for up to 183 days in the primary analysis. The primary safety end point was the incidence of adverse events after a single dose of AZD7442. The primary efficacy end point was symptomatic Covid-19 (SARS-CoV-2 infection confirmed by means of reverse-transcriptase-polymerase-chain-reaction assay) occurring after administration of AZD7442 or placebo and on or before day 183.

RESULTS:

A total of 5197 participants underwent randomization and received one dose of AZD7442 or placebo (3460 in the AZD7442 group and 1737 in the placebo group). The primary analysis was conducted after 30% of the participants had become aware of their randomized assignment. In total, 1221 of 3461 participants (35.3%) in the AZD7442 group and 593 of 1736 participants (34.2%) in the placebo group reported having at least one adverse event, most of which were mild or moderate in severity. Symptomatic Covid-19 occurred in 8 of 3441 participants (0.2%) in the AZD7442 group and in 17 of 1731 participants (1.0%) in the placebo group (relative risk reduction, 76.7%; 95% confidence interval [CI], 46.0 to 90.0; P<0.001); extended follow-up at a median of 6 months showed a relative risk reduction of 82.8% (95% CI, 65.8 to 91.4). Five cases of severe or critical Covid-19 and two Covid-19-related deaths occurred, all in the placebo group.

CONCLUSIONS:

A single dose of AZD7442 had efficacy for the prevention of Covid-19, without evident safety concerns. (Funded by AstraZeneca and the U.S. government; PROVENT ClinicalTrials.gov number, NCT04625725.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Humans Language: English Journal: N Engl J Med Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Humans Language: English Journal: N Engl J Med Year: 2022 Document Type: Article