MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Phase 3 Completed 485 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · collab Cardiothoracic Surgical Trials Network · collab International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) · collab Kirby Institute · collab Medical Research Council · collab Molecular Partners AG · collab National Heart, Lung, and Blood Institute (NHLBI) · collab Prevention and Early Treatment of Acute Lung Injury · collab US Department of Veterans Affairs · collab University of Copenhagen · collab University of Minnesota · collab Washington D.C. Veterans Affairs Medical Center · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This study looks at the safety and effectiveness of MP0420 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either MP0420 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H5.

Timeline

Start: 2021-06-11
Primary completion: 2022-02-23
Completion: 2023-06-08

Outcome

Missed primary endpoint

paper The 90-day cumulative incidence of sustained recovery was 82% for ensovibep and 80% for placebo (subhazard ratio [sHR], 1.06 [CI, 0.88 to 1.28]; PMID 35939810 ↗

paper ensovibep did not improve clinical outcomes for hospitalized participants with COVID-19 receiving standard care, including remdesivir; PMID 35939810 ↗

Publications

Results ACTIV-3/TICO Study Group; Barkauskas C, Mylonakis E, Poulakou G, Young BE, Vock DM, Siegel L, Engen N, Grandits G, Mosaly NR, Vekstein AM, Rogers R, Shehadeh F, Kaczynski M, Mylona EK, Syrigos KN, Rapti V, Lye DC, Hui DS, Leither L, Knowlton KU, Jain MK, Marines-Price R, Osuji A, Overcash JS, Kalomenidis I, Barmparessou Z, Waters M, Zepeda K, Chen P, Torbati S, Kiweewa F, Sebudde N, Almasri E, Hughes A, Bhagani SR, Rodger A, Sandkovsky U, Gottlieb RL, Nnakelu E, Trautner B, Menon V, Lutaakome J, Matthay M, Robinson P, Protopapas K, Koulouris N, Kimuli I, Baduashvili A, Braun DL, Gunthard HF, Ramachandruni S, Kidega R, Kim K, Hatlen TJ, Phillips AN, Murray DD, Jensen TO, Padilla ML, Accardi EX, Shaw-Saliba K, Dewar RL, Teitelbaum M, Natarajan V, Laverdure S, Highbarger HC, Rehman MT, Vogel S, Vallee D, Crew P, Atri N, Schechner AJ, Pett S, Hudson F, Badrock J, Touloumi G, Brown SM, Self WH, North CM, Ginde AA, Chang CC, Kelleher A, Nagy-Agren S, Vasudeva S, Looney D, Nguyen HH, Sanchez A, Weintrob AC, Grund B, Sharma S, Reilly CS, Paredes R, Bednarska A, Gerry NP, Babiker AG, Davey VJ, Gelijns AC, Higgs ES, Kan V, Matthews G, Thompson BT, Legenne P, Chandra R, Lane HC, Neaton JD, Lundgren JD. Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial. Ann Intern Med. 2022 Sep;175(9):1266-1274. doi: 10.7326/M22-1503. Epub 2022 Aug 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ensovibep	Protein / enzyme biologic	600 mg	Intravenous
Background	Remdesivir	Small molecule	—	Intravenous