LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Phase 3 Completed 314 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 Eli Lilly and Company · collab International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) · collab Kirby Institute · collab Medical Research Council · 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 LY3819253 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either LY3819253 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H1.

Timeline

Start: 2020-08-05
Primary completion: 2021-02-01
Completion: 2021-02-01

Outcome

Missed primary endpoint

paper CONCLUSIONS: Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. PMID 33356051 ↗

paper The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47). PMID 33356051 ↗

Publications

Results ACTIV-3/TICO LY-CoV555 Study Group; Lundgren JD, Grund B, Barkauskas CE, Holland TL, Gottlieb RL, Sandkovsky U, Brown SM, Knowlton KU, Self WH, Files DC, Jain MK, Benfield T, Bowdish ME, Leshnower BG, Baker JV, Jensen JU, Gardner EM, Ginde AA, Harris ES, Johansen IS, Markowitz N, Matthay MA, Ostergaard L, Chang CC, Davey VJ, Goodman A, Higgs ES, Murray DD, Murray TA, Paredes R, Parmar MKB, Phillips AN, Reilly C, Sharma S, Dewar RL, Teitelbaum M, Wentworth D, Cao H, Klekotka P, Babiker AG, Gelijns AC, Kan VL, Polizzotto MN, Thompson BT, Lane HC, Neaton JD. A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. N Engl J Med. 2021 Mar 11;384(10):905-914. doi: 10.1056/NEJMoa2033130. Epub 2020 Dec 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bamlanivimab	Monoclonal antibody	7000 mg	Intravenous
Background	Remdesivir	Small molecule	—	Intravenous