Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19
Summary
This placebo controlled study is intended to generate safety and efficacy data in order to provide a treatment option for COVID-19 in patients with a high risk of disease progression based on age or co-morbid medical conditions.
Timeline
- Start
- 2021-07-26
- Primary completion
- 2022-02-10
- Completion
- 2022-11-03
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 vs Placebo IM; p = 0.0047; Risk Difference (RD) -8.7 (95% CI -14.71 to -2.67); Regression, Logistic NCT04805671 ↗
paper a 66% relative risk reduction in favor of adintrevimab (standardized risk difference, -8.7% [95% confidence interval, -14.71% to -2.67%]; P = .0047). PMID 37351456 ↗
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 symptomatic COVID-19 was reduced by 71% compared to placebo in pre-exposure prophylaxis and 75% compared to placebo in post-exposure prophylaxis” invivyd.com ↗
Publications
- Ison MG, Popejoy M, Evgeniev N, Tzekova M, Mahoney K, Betancourt N, Li Y, Gupta D, Narayan K, Hershberger E, Connolly LE, Yalcin I, Das AF, Genge J, Smith M, Campanaro E, Hawn P, Schmidt P; STAMP Study Group. 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. Open Forum Infect Dis. 2023 May 24;10(6):ofad279. doi: 10.1093/ofid/ofad279. eCollection 2023 Jun.
- 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 |