tetano
Editor, Senior Moderator
Open Forum Infect Dis
. 2023 Jun 13;10(7)
fad314.
doi: 10.1093/ofid/ofad314. eCollection 2023 Jul. 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[SUP] 1 [/SUP], Debra F Weinstein[SUP] 2 [/SUP], Marta Dobryanska[SUP] 3 [/SUP], Anna Holmes[SUP] 4 [/SUP], Anne-Marie Phelan[SUP] 4 [/SUP], Yong Li[SUP] 4 [/SUP], Deepali Gupta[SUP] 4 [/SUP], Kristin Narayan[SUP] 4 [/SUP], Kazima Tosh[SUP] 4 [/SUP], Ellie Hershberger[SUP] 4 [/SUP], Lynn E Connolly[SUP] 4 [/SUP], Ilker Yalcin[SUP] 4 [/SUP], Ed Campanaro[SUP] 4 [/SUP], Pamela Hawn[SUP] 4 [/SUP], Pete Schmidt[SUP] 4 [/SUP]; EVADE Study Group
Affiliations
Background: The prevention of coronavirus disease 2019 (COVID-19) 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.
Keywords: COVID-19; SARS-CoV-2; adintrevimab; monoclonal antibody; prevention.
. 2023 Jun 13;10(7)
fad314.doi: 10.1093/ofid/ofad314. eCollection 2023 Jul. 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[SUP] 1 [/SUP], Debra F Weinstein[SUP] 2 [/SUP], Marta Dobryanska[SUP] 3 [/SUP], Anna Holmes[SUP] 4 [/SUP], Anne-Marie Phelan[SUP] 4 [/SUP], Yong Li[SUP] 4 [/SUP], Deepali Gupta[SUP] 4 [/SUP], Kristin Narayan[SUP] 4 [/SUP], Kazima Tosh[SUP] 4 [/SUP], Ellie Hershberger[SUP] 4 [/SUP], Lynn E Connolly[SUP] 4 [/SUP], Ilker Yalcin[SUP] 4 [/SUP], Ed Campanaro[SUP] 4 [/SUP], Pamela Hawn[SUP] 4 [/SUP], Pete Schmidt[SUP] 4 [/SUP]; EVADE Study Group
Affiliations
- PMID: 37496612
- PMCID: PMC10368201
- DOI: 10.1093/ofid/ofad314
Background: The prevention of coronavirus disease 2019 (COVID-19) 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.
Keywords: COVID-19; SARS-CoV-2; adintrevimab; monoclonal antibody; prevention.