tetano
Editor, Senior Moderator
Open Forum Infect Dis
. 2023 May 24;10(6)
fad279.
doi: 10.1093/ofid/ofad279. eCollection 2023 Jun. Efficacy and Safety of Adintrevimab (ADG20) for the Treatment of High-Risk Ambulatory Patients With Mild or Moderate Coronavirus Disease 2019: Results From a Phase 2/3, Randomized, Placebo-Controlled Trial (STAMP) Conducted During Delta Predominance and Early Emergence of Omicron
Michael G Ison[SUP] 1 [/SUP], Myra Popejoy[SUP] 2 [/SUP], Nikolay Evgeniev[SUP] 3 [/SUP], Maria Tzekova[SUP] 4 [/SUP], Kathryn Mahoney[SUP] 2 [/SUP], Natalia Betancourt[SUP] 2 [/SUP], Yong Li[SUP] 2 [/SUP], Deepali Gupta[SUP] 2 [/SUP], Kristin Narayan[SUP] 2 [/SUP], Ellie Hershberger[SUP] 2 [/SUP], Lynn E Connolly[SUP] 2 [/SUP], Ilker Yalcin[SUP] 2 [/SUP], Anita F Das[SUP] 2 [/SUP], John Genge[SUP] 2 [/SUP], Michelle Smith[SUP] 2 [/SUP], Ed Campanaro[SUP] 2 [/SUP], Pamela Hawn[SUP] 2 [/SUP], Pete Schmidt[SUP] 2 [/SUP]; STAMP Study Group
Collaborators, Affiliations
Background: Safe and effective treatments are needed to prevent severe outcomes in individuals with coronavirus disease 2019 (COVID-19). We report results from STAMP, a phase 2/3, multicenter, double-blind, randomized, placebo-controlled trial of adintrevimab, an extended half-life monoclonal antibody, for treatment of high-risk ambulatory patients with mild to moderate COVID-19.
Methods: Nonhospitalized, unvaccinated participants aged ≥12 years with mild to moderate COVID-19 and ≥1 risk factor for disease progression were randomized to receive a single intramuscular injection of 300 mg adintrevimab or placebo. Enrollment was paused due to the global emergence of the Omicron BA.1/BA1.1 variants, against which adintrevimab showed reduced activity in vitro. The primary efficacy endpoint was COVID-19-related hospitalization or all-cause death through day 29 in participants with COVID-19 due to laboratory-confirmed or suspected non-Omicron severe acute respiratory syndrome coronavirus 2 variants.
Results: Between 8 August 2021 and 11 January 2022, 399 participants were randomized to receive adintrevimab (n = 198) or placebo (n = 201), including 336 with COVID-19 due to non-Omicron variants. COVID-19-related hospitalization or all-cause death through day 29 occurred in 8 of 169 (4.7%) participants in the adintrevimab group and 23 of 167 (13.8%) participants in the placebo group, a 66% relative risk reduction in favor of adintrevimab (standardized risk difference, -8.7% [95% confidence interval, -14.71% to -2.67%]; P = .0047). Incidence of treatment-emergent adverse events (TEAEs) was similar between treatment groups (33.9% for adintrevimab and 39.5% for placebo). No adintrevimab-related serious TEAEs were reported.
Conclusions: Treatment with a single intramuscular injection of adintrevimab provided protection against severe outcomes in high-risk ambulatory participants with COVID-19 due to susceptible variants, without safety concerns. Clinical Trial Registration. NCT04805671.
Keywords: COVID-19; SARS-CoV-2; adintrevimab; monoclonal antibody; treatment.
. 2023 May 24;10(6)
fad279.doi: 10.1093/ofid/ofad279. eCollection 2023 Jun. Efficacy and Safety of Adintrevimab (ADG20) for the Treatment of High-Risk Ambulatory Patients With Mild or Moderate Coronavirus Disease 2019: Results From a Phase 2/3, Randomized, Placebo-Controlled Trial (STAMP) Conducted During Delta Predominance and Early Emergence of Omicron
Michael G Ison[SUP] 1 [/SUP], Myra Popejoy[SUP] 2 [/SUP], Nikolay Evgeniev[SUP] 3 [/SUP], Maria Tzekova[SUP] 4 [/SUP], Kathryn Mahoney[SUP] 2 [/SUP], Natalia Betancourt[SUP] 2 [/SUP], Yong Li[SUP] 2 [/SUP], Deepali Gupta[SUP] 2 [/SUP], Kristin Narayan[SUP] 2 [/SUP], Ellie Hershberger[SUP] 2 [/SUP], Lynn E Connolly[SUP] 2 [/SUP], Ilker Yalcin[SUP] 2 [/SUP], Anita F Das[SUP] 2 [/SUP], John Genge[SUP] 2 [/SUP], Michelle Smith[SUP] 2 [/SUP], Ed Campanaro[SUP] 2 [/SUP], Pamela Hawn[SUP] 2 [/SUP], Pete Schmidt[SUP] 2 [/SUP]; STAMP Study Group
Collaborators, Affiliations
- PMID: 37351456
- PMCID: PMC10284338
- DOI: 10.1093/ofid/ofad279
Background: Safe and effective treatments are needed to prevent severe outcomes in individuals with coronavirus disease 2019 (COVID-19). We report results from STAMP, a phase 2/3, multicenter, double-blind, randomized, placebo-controlled trial of adintrevimab, an extended half-life monoclonal antibody, for treatment of high-risk ambulatory patients with mild to moderate COVID-19.
Methods: Nonhospitalized, unvaccinated participants aged ≥12 years with mild to moderate COVID-19 and ≥1 risk factor for disease progression were randomized to receive a single intramuscular injection of 300 mg adintrevimab or placebo. Enrollment was paused due to the global emergence of the Omicron BA.1/BA1.1 variants, against which adintrevimab showed reduced activity in vitro. The primary efficacy endpoint was COVID-19-related hospitalization or all-cause death through day 29 in participants with COVID-19 due to laboratory-confirmed or suspected non-Omicron severe acute respiratory syndrome coronavirus 2 variants.
Results: Between 8 August 2021 and 11 January 2022, 399 participants were randomized to receive adintrevimab (n = 198) or placebo (n = 201), including 336 with COVID-19 due to non-Omicron variants. COVID-19-related hospitalization or all-cause death through day 29 occurred in 8 of 169 (4.7%) participants in the adintrevimab group and 23 of 167 (13.8%) participants in the placebo group, a 66% relative risk reduction in favor of adintrevimab (standardized risk difference, -8.7% [95% confidence interval, -14.71% to -2.67%]; P = .0047). Incidence of treatment-emergent adverse events (TEAEs) was similar between treatment groups (33.9% for adintrevimab and 39.5% for placebo). No adintrevimab-related serious TEAEs were reported.
Conclusions: Treatment with a single intramuscular injection of adintrevimab provided protection against severe outcomes in high-risk ambulatory participants with COVID-19 due to susceptible variants, without safety concerns. Clinical Trial Registration. NCT04805671.
Keywords: COVID-19; SARS-CoV-2; adintrevimab; monoclonal antibody; treatment.