Evaluation of ADG20 for the Prevention of COVID-19

Summary

This placebo-controlled study is intended to evaluate ADG20's safety and ability to prevent COVID-19 infection.

Timeline

Start

2021-04-27

Primary completion

2022-11-04

Completion

2022-11-04

Outcome

Met primary endpoint

Stopped: “All primary efficacy data has been collected and analyzed. Based on the safety data gathered to date, it has been determined that continued participation by study subjects would not yield any additional beneficial safety information.”

registry analysis (superiority test); ADG20 IM - Cohort A vs Placebo IM - Cohort A; p = 0.0123; Risk Difference (RD) -5.0 (95% CI -8.87 to -1.08); Regression, Logistic NCT04859517 ↗

registry analysis (superiority test); ADG20 IM - Cohort B vs Placebo IM - Cohort B; p <0.0001; Risk Difference (RD) -3.9 (95% CI -5.75 to -2.01); Regression, Logistic NCT04859517 ↗

release “reported that the primary endpoints were met with statistical significance for all three indications in the company’s ongoing global Phase 2/3 clinical trials” invivyd.com ↗

release “Risk of hospitalization or death in participants with mild to moderate COVID-19 was reduced by 66% compared to placebo in the primary efficacy analysis population” invivyd.com ↗

Publications

• Ison MG, Weinstein DF, Dobryanska M, Holmes A, Phelan AM, Li Y, Gupta D, Narayan K, Tosh K, Hershberger E, Connolly LE, Yalcin I, Campanaro E, Hawn P, Schmidt P; EVADE Study Group. Prevention of COVID-19 Following a Single Intramuscular Administration of Adintrevimab: Results From a Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial (EVADE). Open Forum Infect Dis. 2023 Jun 13;10(7):ofad314. doi: 10.1093/ofid/ofad314. eCollection 2023 Jul.
• Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ADG20	Monoclonal antibody	300 mg	Intramuscular

Indications