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Randomized Controlled Trial
. 2021 Oct 21;22(1):726.
doi: 10.1186/s13063-021-05699-3.

Innovative clinical trial design and delivery: a phase 3 COVID-19 post-exposure prophylaxis study in skilled nursing and assisted living facilities (BLAZE-2)

Jack Knorr  1 , Jay L Tuttle  2 , Janelle A Sabo  2 , Dawn H East  2 , Karen L Price  2 , Lei Shen  2
Affiliations
Randomized Controlled Trial

Innovative clinical trial design and delivery: a phase 3 COVID-19 post-exposure prophylaxis study in skilled nursing and assisted living facilities (BLAZE-2)

Jack Knorr et al. Trials. .

Abstract

The efficient community spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in the current pandemic of coronavirus disease-2019 (COVID-19), which in severe and critical cases results in progressive pulmonary infection, complicated by respiratory failure, with a high prevalence of acute respiratory distress syndrome. Of all age groups, older adults have the greatest risk of severe COVID-19 and the associated complications. Globally, there are many reports of the rapid spread of COVID-19 among residents of skilled nursing facilities, with high associated rates of morbidity and mortality. With over 1.3 million residents in nursing home care in the USA, there is an urgent need for therapeutic strategies to prevent COVID-19 in these populations.Lilly, in collaboration with the National Institute of Allergy and Infectious Diseases, conducted the BLAZE-2 trial to evaluate the efficacy and safety of the monoclonal antibody bamlanivimab (LY3819253) in preventing SARS-CoV-2 infection and COVID-19, defined as symptomatic infection, in skilled nursing and assisted living facilities. It is a phase 3 randomized, double-blind, placebo-controlled trial, where participants were randomized to bamlanivimab (4200 mg) or placebo and then followed up for 24 weeks. Conducting a trial in the midst of a pandemic in these facilities poses several challenges, including a vulnerable elderly population, travel restrictions, supply chain interruptions, and defining the target population. The operational challenges were addressed by the innovative use of mobile research units which are customized, equipped, and staffed to support BLAZE-2 randomization and participant dosing within the skilled nursing and assisted living facilities. Herein, we describe the design of the study, the analytics behind facility selection, and an innovative operational model.

Keywords: BLAZE-2; Bamlanivimab; COVID-19; LY3819253; SARS-CoV-2.

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Conflict of interest statement

JK, JLT, JAS, DHE, KLP, and LS are employees and shareholders of Eli Lilly and Company.

Figures

Fig. 1
Fig. 1
Study design. Abbreviation: PBO placebo
Fig. 2
Fig. 2
Logistic overview of the BLAZE-2 study. Abbreviation: MRU mobile research unit
Fig. 3
Fig. 3
BLAZE-2 trial site map, US. Yellow circles represent facilities
Fig. 4
Fig. 4
Mobile research unit and on-site setups
See this image and copyright information in PMC

References

    1. World Health Organization. Weekly epidemiological update - 2 February 2021. https://www.who.int/publications/m/item/weekly-epidemiological-update%2D.... Accessed 05 Feb 2021.
    1. [CDC] Centers for Disease Control and Prevention. Older adults. Updated 30 April 2020. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-a.... Accessed 01 Jun 2020.
    1. Grabowski DC, Mor V. Nursing home care in crisis in the wake of COVID-19. JAMA. 2020;324(1):23–24. doi: 10.1001/jama.2020.8524. - DOI - PubMed
    1. Ng WH, Tipih T, Makoah NA, et al. Comorbidities in SARS-CoV-2 patients: a systematic review and meta-analysis. mBio. 2021;12(1):e03647–e03620. doi: 10.1128/mBio.03647-20. - DOI - PMC - PubMed
    1. Arons MM, Hatfield KM, Reddy SC, Kimball A, James A, Jacob JR, et al. Presymptomatic SARS-CoV-2 infections and transmission in a skilled nursing facility. N Engl J Med. 2020;382(22):2081–2090. doi: 10.1056/NEJMoa2008457. - DOI - PMC - PubMed