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All Studies   All Outcomes    Recent:   

Prevention of COVID-19 Following a Single Intramuscular Administration of Adintrevimab: Results From a Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial (EVADE)

Ison et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofad314, EVADE PrEP, NCT04859517
Jun 2023  
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Mortality, COVID-19 33% Improvement Relative Risk Mortality, all-cause 50% Mortality 84% Hospitalization 84% Symp. case 70% Adintrevimab  EVADE PrEP  Prophylaxis  DB RCT Is prophylaxis with adintrevimab beneficial for COVID-19? Double-blind RCT 2,002 patients in the USA (April 2021 - January 2022) Fewer symptomatic cases with adintrevimab (p=0.000083) c19early.org Ison et al., Open Forum Infectious Dis.., Jun 2023 Favorsadintrevimab Favorscontrol 0 0.5 1 1.5 2+
PrEP RCT 1480 patients, showing lower COVID-19 cases with adintrevimab. The PEP trial is listed separately1.
risk of death, 33.3% lower, RR 0.67, p = 1.00, treatment 2 of 1,001 (0.2%), control 3 of 1,001 (0.3%), NNT 1001, COVID-19, 6 months, supplementary table 6.
risk of death, 50.0% lower, RR 0.50, p = 0.51, treatment 3 of 1,001 (0.3%), control 6 of 1,001 (0.6%), NNT 334, all-cause, 6 months, supplementary table 6.
risk of death, 83.9% lower, RR 0.16, p = 0.07, treatment 1 of 752 (0.1%), control 6 of 728 (0.8%), NNT 145, 3 months.
risk of hospitalization, 83.9% lower, RR 0.16, p = 0.07, treatment 1 of 752 (0.1%), control 6 of 728 (0.8%), NNT 145, 3 months.
risk of symptomatic case, 70.2% lower, RR 0.30, p < 0.001, treatment 12 of 752 (1.6%), control 39 of 728 (5.4%), NNT 27, 3 months.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Ison et al., 13 Jun 2023, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 15 authors, study period 27 April, 2021 - 11 January, 2022, trial NCT04859517 (history) (EVADE PrEP). Contact: pschmidt@invivyd.com.
This PaperAdintrevimabAll
Prevention of COVID-19 Following a Single Intramuscular Administration of Adintrevimab: Results From a Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial (EVADE)
Michael G Ison, Debra F Weinstein, Marta Dobryanska, Anna Holmes, Anne-Marie Phelan, Yong Li, Deepali Gupta, Kristin Narayan, Kazima Tosh, Ellie Hershberger, Lynn E Connolly, Ilker Yalcin, Ed Campanaro, Pamela Hawn, MD Pete Schmidt
Open Forum Infectious Diseases, doi:10.1093/ofid/ofad314
Background. The prevention of coronavirus disease 2019 in vulnerable populations is a global health priority. EVADE was a phase 2/3 multicenter, double-blind, randomized, placebo-controlled trial of adintrevimab, an extended-half-life monoclonal antibody, for postexposure (PEP) and pre-exposure prophylaxis (PrEP) of symptomatic COVID-19. Methods. Eligible participants (vaccine-naive, aged ≥12 years) were randomized 1:1 to receive a single 300-mg intramuscular injection of adintrevimab or placebo. Primary efficacy end points were reverse transcription polymerase chain reaction (RT-PCR)confirmed symptomatic COVID-19 through day 28 in the PEP cohort (RT-PCR-negative at baseline) and through month 3 in the PrEP cohort (RT-PCR-negative and seronegative at baseline) among participants randomized before emergence of the severe acute respiratory syndrome coronavirus 2 Omicron variant (November 30, 2021). Safety was assessed through 6 months. Results. Between April 27, 2021, and January 11, 2022, 2582 participants were randomized. In the primary efficacy analysis, RT-PCR-confirmed symptomatic COVID-19 occurred in 3/175 (1.7%) vs 12/176 (6.8%) adintrevimab-and placebo-treated PEP participants, respectively (74.9% relative risk reduction [RRR]; standardized risk difference, -5.0%; 95% CI, -8.87% to -1.08%; P = .0123) and in 12/752 (1.6%) vs 40/728 (5.5%) adintrevimab-and placebo-treated PrEP participants, respectively (71.0% RRR; standardized risk difference, -3.9%; 95% CI, -5.75% to -2.01%; P < .0001). In a prespecified exploratory analysis of 428 PrEP participants randomized after the emergence of Omicron, adintrevimab reduced RT-PCR-confirmed symptomatic COVID-19 by 40.6% (standardized risk difference -8.4%; 95% CI, -15.35% to -1.46%; nominal P = .0177) vs placebo. Adintrevimab was well tolerated, with no serious drug-related adverse events reported. Conclusions. A single intramuscular injection of adintrevimab provided prophylactic efficacy against COVID-19 due to susceptible variants without safety concerns. Clinical trial registration. NCT04859517.
Supplementary Data Supplementary materials are available at Open Forum Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author. Author contributions. L.E.C., A.H., A.P., and K.N. contributed to study design. L.E.C., A.H., A.P., and K.N. were involved in protocol development. D.W. and M.D. were principal investigators. P.S. provided oversight and leadership responsibility for the research activity planning and execution. A.H. and P.S. were responsible for medical monitoring. All authors contributed to data interpretation and were involved in drafting and critically revising the manuscript, and all authors approved the final version and are accountable for the accuracy and integrity of the manuscript. All authors had full access to the data in the study and had final responsibility for the decision to submit for publication. Y.L. and D.G. verified the data. Financial support. This work was supported by Invivyd, Inc. (formerly Adagio Therapeutics, Inc.). Potential conflicts of interest. At the time of the study, M.G.I. received research support, paid to Northwestern University, from GlaxoSmithKline; received payment for consultation from ADMA Biologics, AlloVir, Atea, Cidara, Genentech, Invivyd, Roche, Janssen, Shionogi, Takeda, and Viracor Eurofins; received royalties from UpToDate;..
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Safety was assessed through 6 months.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>Between 27 April 2021, and 11 January 2022, 2582 participants were ' 'randomized. In the primary efficacy analysis, RT-PCR-confirmed symptomatic COVID-19 occurred ' 'in 3/175 (1.7%) vs 12/176 (6.8%) adintrevimab- and placebo-treated PEP participants, ' 'respectively (74.9% relative risk reduction [RRR]; standardized risk difference –5.0%; 95% ' 'CI, –8.87 to –1.08; P=.0123), and in 12/752 (1.6%) vs 40/728 (5.5%) adintrevimab- and ' 'placebo-treated PrEP participants, respectively (71.0% RRR; standardized risk difference ' '–3.9%; 95% CI, –5.75 to –\u200d2.01; P&amp;lt;.0001). In a prespecified exploratory analysis ' 'of 428 PrEP participants randomized after emergence of Omicron, adintrevimab reduced ' 'RT-PCR-confirmed symptomatic COVID-19 by 40.6% (standardized risk difference −8.4%; 95% CI, ' '−15.35 to −1.46; nominal P=.0177) vs placebo. Adintrevimab was well tolerated with no serious ' 'drug-related adverse events reported.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>A single intramuscular injection of adintrevimab provided ' 'prophylactic efficacy against COVID-19 due to susceptible variants without safety ' 'concerns.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1093/ofid/ofad314', 'type': 'journal-article', 'created': {'date-parts': [[2023, 6, 13]], 'date-time': '2023-06-13T20:56:39Z', 'timestamp': 1686689799000}, 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Prevention of COVID-19 Following a Single Intramuscular Administration of Adintrevimab: Results ' 'From a Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial (EVADE)', 'prefix': '10.1093', 'author': [ { 'given': 'Michael G', 'family': 'Ison', 'sequence': 'first', 'affiliation': [ { 'name': 'Respiratory Diseases Branch, Division of Microbiology and ' 'Infectious Diseases, National Institute of Allergy and ' 'Infectious Diseases , Rockville, Maryland , USA'}]}, { 'given': 'Debra F', 'family': 'Weinstein', 'sequence': 'additional', 'affiliation': [{'name': 'Science 37 Inc. , Culver City, California , USA'}]}, { 'given': 'Marta', 'family': 'Dobryanska', 'sequence': 'additional', 'affiliation': [ { 'name': 'Kyiv City Clinical Hospital No. 12, Department of Emergency Care ' 'and ARENSIA Exploratory Medicine , Kyiv , Ukraine'}]}, { 'given': 'Anna', 'family': 'Holmes', 'sequence': 'additional', 'affiliation': [{'name': 'Invivyd, Inc. , Waltham, Massachusetts , USA'}]}, { 'given': 'Anne-Marie', 'family': 'Phelan', 'sequence': 'additional', 'affiliation': [{'name': 'Invivyd, Inc. , Waltham, Massachusetts , USA'}]}, { 'given': 'Yong', 'family': 'Li', 'sequence': 'additional', 'affiliation': [{'name': 'Invivyd, Inc. , Waltham, Massachusetts , USA'}]}, { 'given': 'Deepali', 'family': 'Gupta', 'sequence': 'additional', 'affiliation': [{'name': 'Invivyd, Inc. , Waltham, Massachusetts , USA'}]}, { 'given': 'Kristin', 'family': 'Narayan', 'sequence': 'additional', 'affiliation': [{'name': 'Invivyd, Inc. , Waltham, Massachusetts , USA'}]}, { 'given': 'Kazima', 'family': 'Tosh', 'sequence': 'additional', 'affiliation': [{'name': 'Invivyd, Inc. , Waltham, Massachusetts , USA'}]}, { 'given': 'Ellie', 'family': 'Hershberger', 'sequence': 'additional', 'affiliation': [{'name': 'Invivyd, Inc. , Waltham, Massachusetts , USA'}]}, { 'given': 'Lynn E', 'family': 'Connolly', 'sequence': 'additional', 'affiliation': [{'name': 'Invivyd, Inc. , Waltham, Massachusetts , USA'}]}, { 'given': 'Ilker', 'family': 'Yalcin', 'sequence': 'additional', 'affiliation': [{'name': 'Invivyd, Inc. , Waltham, Massachusetts , USA'}]}, { 'given': 'Ed', 'family': 'Campanaro', 'sequence': 'additional', 'affiliation': [{'name': 'Invivyd, Inc. , Waltham, Massachusetts , USA'}]}, { 'given': 'Pamela', 'family': 'Hawn', 'sequence': 'additional', 'affiliation': [{'name': 'Invivyd, Inc. , Waltham, Massachusetts , USA'}]}, { 'given': 'Pete', 'family': 'Schmidt', 'sequence': 'additional', 'affiliation': [{'name': 'Invivyd, Inc. , Waltham, Massachusetts , USA'}]}, {'name': 'for the EVADE Study Group', 'sequence': 'additional', 'affiliation': []}], 'member': '286', 'published-online': {'date-parts': [[2023, 6, 13]]}, 'container-title': 'Open Forum Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://academic.oup.com/ofid/advance-article-pdf/doi/10.1093/ofid/ofad314/50598666/ofad314.pdf', 'content-type': 'application/pdf', 'content-version': 'am', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/ofid/advance-article-pdf/doi/10.1093/ofid/ofad314/50598666/ofad314.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 6, 13]], 'date-time': '2023-06-13T20:56:39Z', 'timestamp': 1686689799000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofad314/7197273'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2023, 6, 13]]}, 'references-count': 0, 'URL': 'http://dx.doi.org/10.1093/ofid/ofad314', 'relation': {}, 'ISSN': ['2328-8957'], 'subject': ['Infectious Diseases', 'Oncology'], 'published': {'date-parts': [[2023, 6, 13]]}}
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