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Clinical Trial
. 2022 Feb:113:106652.
doi: 10.1016/j.cct.2021.106652. Epub 2021 Dec 9.

Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days

Erin K McCreary  1 , J Ryan Bariola  2 , Tami Minnier  3 , Richard J Wadas  4 , Judith A Shovel  3 , Debbie Albin  5 , Oscar C Marroquin  6 , Mark Schmidhofer  7 , Mary Kay Wisniewski  3 , David A Nace  8 , Colleen Sullivan  9 , Meredith Axe  4 , Russell Meyers  4 , Tina Khadem  2 , William Garrard  6 , Kevin Collins  6 , Alan Wells  10 , Robert D Bart  11 , Kelsey Linstrum  12 , Stephanie K Montgomery  12 , Ghady Haidar  2 , Graham M Snyder  2 , Bryan J McVerry  13 , Christopher W Seymour  14 , Donald M Yealy  4 , David T Huang  15 , Derek C Angus  14
Affiliations
Clinical Trial

Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days

Erin K McCreary et al. Contemp Clin Trials. 2022 Feb.

Abstract

Outpatient treatments that limit progression to severe coronavirus disease 2019 (COVID-19) are of vital importance to optimise patient outcomes and public health. Monoclonal antibodies (mAb) demonstrated ability to decrease hospitalizations in randomized, clinical trials. However, there are many barriers to mAb treatment such as patient access and clinician education. There are no data comparing efficacy or safety of available mAbs. We sought to rapidly launch an adaptive platform trial with the goals of enhancing access to treatment, regardless of geography and socioeconomic status, and evaluating comparative efficacy and safety of available mAbs. Within 21 days from idea genesis, we allocated mAb treatment to all patients within the context of this clinical trial. Within 2 months, we closed the gap of the likelihood of receiving mAb, conditional on background positivity rate, between Black and White patients (Black patients 0.238; White patients 0.241). We describe trial infrastructure, lessons learned, and future directions for a culture of learning while doing.

Keywords: Bamlanivimab; COVID-19; Casirivimab; Etesevimab; Imdevimab; Monoclonal antibodies; SARS-CoV-2.

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Figures

Fig. 1
Fig. 1
Monoclonal antibody assignment application.
Fig. 2
Fig. 2
COVID-19 monoclonal antibody team.
Fig. 3
Fig. 3
Monoclonal antibody patient outreach efforts.
See this image and copyright information in PMC

References

    1. Alberti P.M., Lantz P.M., Wilkins C.H. Equitable pandemic preparedness and rapid response: lessons from COVID-19 for pandemic health equity. J. Health Polit. Policy Law. 2020;45(6):921–935. doi: 10.1215/03616878-8641469. (In eng) - DOI - PubMed
    1. Chen P., Nirula A., Heller B., et al. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with COVID-19. N. Engl. J. Med. 2021;384(3):229–237. doi: 10.1056/NEJMoa2029849. (In eng) - DOI - PMC - PubMed
    1. Weinreich D.M., Sivapalasingam S., Norton T., et al. REGN-COV2, a neutralizing antibody cocktail, in outpatients with COVID-19. N. Engl. J. Med. 2021;384(3):238–251. doi: 10.1056/NEJMoa2035002. (In eng) - DOI - PMC - PubMed
    1. Gottlieb R.L., Nirula A., Chen P., et al. Effect of bamlanivimab as monotherapy or in combination with Etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial. Jama. 2021;325(7):632–644. doi: 10.1001/jama.2021.0202. (In eng) - DOI - PMC - PubMed
    1. Bariola J.R., McCreary E.K., Wadas R.J., et al. Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection. medRxiv. 2021 doi: 10.1101/2021.03.25.21254322. 2021.03.25.21254322. - DOI - PMC - PubMed

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