Evidence map›Paper›PMID 35443106›Full record

Trial reportThe New England journal of medicine2022

Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19.

Myron J Levin, Andrew Ustianowski, Stéphane De Wit, Odile Launay, Miles Avila, Alison Templeton, Yuan Yuan, Seth Seegobin, Adam Ellery, Dennis J Levinson and 15 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 405 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
405citing papers in PubMed, 7 pooled it
64.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04625725 phase3completednot on this map

A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19.

TypeinterventionalSponsorAstraZenecaRan2020 to 2023Enrolled5,197ConditionsCOVID-19ArmsAZD7442, Placebo
NCT05629923 completednot on this map

Evaluation of covid-19 vaccination efficacy and contixagevimab-cilgavimab prophylaxis in liver and kidney transplant patients: preliminary study

TypeobservationalSponsorUniversity of Rome Tor VergataRan2022 to 2022Enrolled306ConditionsCOVID-19 Pandemic, Transplant-Related DisorderArmstixagevimab-cilgavimab(AZD7442, AstraZeneca)
NCT05648110 phase2 / phase3completednot on this map

A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants With Conditions Causing Immune Impairment. Sub-study: Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19

TypeinterventionalSponsorAstraZenecaRan2022 to 2025Enrolled3,882ConditionsCOVID-19, SARS-CoV-2ArmsAZD5156 (Parent study Sentinel Safety Cohort), Placebo (Parent study Sentinel Safety Cohort), EVUSHELD™ (Parent study Main Cohort), AZD3152 (Parent study Main Cohort), Placebo (Parent study Main Cohort)
3 · Its place in the literature

Who cites it

405 citing papers in PubMed, 7 syntheses or guidelines pooled it, 658 citations in OpenAlex.

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  17. A Randomized, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of VIR-2482 in Healthy Adults for Prevention of Influenza A Illness (PENINSULA).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
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345 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 1 institution in 2 countries.

Myron J LevinFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Andrew UstianowskiFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Stéphane De WitFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Odile LaunayFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Miles AvilaFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Alison TempletonFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Yuan YuanFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Seth SeegobinFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Adam ElleryFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Dennis J LevinsonFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Philip AmberyFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Rosalinda H ArendsFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Rohini BeavonFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Kanika DeyFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Pedro GarbesFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Elizabeth J KellyFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Gavin C K W KohFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Karen A NearFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Kelly W PadillaFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Konstantina PsachouliaFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Audrey SharbaughFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Katie StreicherFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Menelas N PangalosFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
Mark T EsserFrom 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, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).
PROVENT Study Group
University of Colorado Hospital · US

Funding

U.S. Department of Defense W911QY-21-9-0001U.S. Department of Health and Human Services W911QY-21-9-0001
6 · The paper itself

Abstract

backgroundThe 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.

methodsIn 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 2:1 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.

resultsA 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.

conclusionsA 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.).

Indexed as

Antiviral AgentsCOVID-19AdultAntibodies, MonoclonalAntibodies, NeutralizingDouble-Blind MethodDrug CombinationsHumansInjections, IntramuscularSARS-CoV-2Antibodies, MonoclonalAntibodies, NeutralizingAntiviral Agentscilgavimabcilgavimab and tixagevimab drug combinationDrug Combinationstixagevimab

Identifiers

PMID35443106
PMCPMC9069994
OpenAlexW4224289402

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.