Dataset Information

Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.

ABSTRACT:

Background

Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.

Objective

To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone.

Design

Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978).

Setting

Multinational, multicenter trial.

Participants

Adults hospitalized with COVID-19.

Intervention

Intravenous ensovibep, 600 mg, or placebo.

Measurements

Ensovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day 90, defined as 14 consecutive days at home or place of usual residence after hospital discharge. A composite safety outcome that included death, serious adverse events, end-organ disease, and serious infections was assessed through day 90.

Results

An independent data and safety monitoring board recommended that enrollment be halted for early futility after 485 patients were randomly assigned and received an infusion of ensovibep (n = 247) or placebo (n = 238). The odds ratio (OR) for a more favorable pulmonary outcome in the ensovibep (vs. placebo) group at day 5 was 0.93 (95% CI, 0.67 to 1.30; P = 0.68; OR > 1 would favor ensovibep). 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]; sHR > 1 would favor ensovibep). The primary composite safety outcome at day 90 occurred in 78 ensovibep participants (32%) and 70 placebo participants (29%) (HR, 1.07 [CI, 0.77 to 1.47]; HR < 1 would favor ensovibep).

Limitation

The trial was prematurely stopped because of futility, limiting power for the primary outcome.

Conclusion

Compared with placebo, ensovibep did not improve clinical outcomes for hospitalized participants with COVID-19 receiving standard care, including remdesivir; no safety concerns were identified.

Primary funding source

National Institutes of Health.

SUBMITTER: ACTIV-3/TICO Study Group

PROVIDER: S-EPMC9384272 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.

Barkauskas Christina C Mylonakis Eleftherios E Poulakou Garyfallia G Young Barnaby E BE Vock David M DM Siegel Lianne L Engen Nicole N Grandits Greg G Mosaly Nilima R NR Vekstein Andrew M AM Rogers Ralph R Shehadeh Fadi F Kaczynski Matthew M Mylona Evangelia K EK Syrigos Konstantinos N KN Rapti Vasiliki V Lye David C DC Hui Diong Shiau DS Leither Lindsay L Knowlton Kirk U KU Jain Mamta K MK Marines-Price Rubria R Osuji Alice A Overcash J Scott JS Kalomenidis Ioannis I Barmparessou Zafeiria Z Waters Michael M Zepeda Karla K Chen Peter P Torbati Sam S Kiweewa Francis F Sebudde Nicholus N Almasri Eyad E Hughes Alyssa A Bhagani Sanjay R SR Rodger Alison A Sandkovsky Uriel U Gottlieb Robert L RL Nnakelu Eriobu E Trautner Barbara B Menon Vidya V Lutaakome Joseph J Matthay Michael M Robinson Philip P Protopapas Konstantinos K Koulouris Nikolaos N Kimuli Ivan I Baduashvili Amiran A Braun Dominique L DL Günthard Huldrych F HF Ramachandruni Srikanth S Kidega Robert R Kim Kami K Hatlen Timothy J TJ Phillips Andrew N AN Murray Daniel D DD Jensen Tomas O TO Padilla Maria L ML Accardi Evan X EX Shaw-Saliba Katy K Dewar Robin L RL Teitelbaum Marc M Natarajan Ven V Laverdure Sylvain S Highbarger Helene C HC Rehman M Tauseef MT Vogel Susan S Vallée David D Crew Page P Atri Negin N Schechner Adam J AJ Pett Sarah S Hudson Fleur F Badrock Jonathan J Touloumi Giota G Brown Samuel M SM Self Wesley H WH North Crystal M CM Ginde Adit A AA Chang Christina C CC Kelleher Anthony A Nagy-Agren Stephanie S Vasudeva Shikha S Looney David D Nguyen Hien H HH Sánchez Adriana A Weintrob Amy C AC Grund Birgit B Sharma Shweta S Reilly Cavan S CS Paredes Roger R Bednarska Agnieszka A Gerry Norman P NP Babiker Abdel G AG Davey Victoria J VJ Gelijns Annetine C AC Higgs Elizabeth S ES Kan Virginia V Matthews Gail G Thompson B Taylor BT Legenne Philippe P Chandra Richa R Lane H Clifford HC Neaton James D JD Lundgren Jens D JD

Annals of internal medicine 20220809 9

<h4>Background</h4>Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.<h4>Objective</h4>To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone.<h4>Design</h4>Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978).<h4>Setting</h4 ...[more]

PMID: 35939810

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Dataset Information

Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.

Background

Objective

Design

Setting

Participants

Intervention

Measurements

Results

Limitation

Conclusion

Primary funding source

Publications

Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.

Similar Datasets

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