tetano
Editor, Senior Moderator
Contemp Clin Trials
. 2021 Dec 8;106652.
doi: 10.1016/j.cct.2021.106652. Online ahead of print.
Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days
Erin K McCreary[SUP] 1 [/SUP], J Ryan Bariola[SUP] 2 [/SUP], Tami Minnier[SUP] 3 [/SUP], Richard J Wadas[SUP] 4 [/SUP], Judith A Shovel[SUP] 3 [/SUP], Debbie Albin[SUP] 5 [/SUP], Oscar C Marroquin[SUP] 6 [/SUP], Mark Schmidhofer[SUP] 7 [/SUP], Mary Kay Wisniewski[SUP] 3 [/SUP], David A Nace[SUP] 8 [/SUP], Colleen Sullivan[SUP] 9 [/SUP], Meredith Axe[SUP] 4 [/SUP], Russell Meyer[SUP] 4 [/SUP], Tina Khadem[SUP] 2 [/SUP], William Garrard[SUP] 6 [/SUP], Kevin Collins[SUP] 6 [/SUP], Alan Wells[SUP] 10 [/SUP], Robert D Bart[SUP] 11 [/SUP], Kelsey Linstrum[SUP] 12 [/SUP], Stephanie K Montgomery[SUP] 12 [/SUP], Ghady Haidar[SUP] 2 [/SUP], Graham M Snyder[SUP] 2 [/SUP], Bryan J McVerry[SUP] 13 [/SUP], Christopher W Seymour[SUP] 14 [/SUP], Donald M Yealy[SUP] 4 [/SUP], David T Huang[SUP] 15 [/SUP], Derek C Angus[SUP] 14 [/SUP]
Affiliations
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.
. 2021 Dec 8;106652.
doi: 10.1016/j.cct.2021.106652. Online ahead of print.
Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days
Erin K McCreary[SUP] 1 [/SUP], J Ryan Bariola[SUP] 2 [/SUP], Tami Minnier[SUP] 3 [/SUP], Richard J Wadas[SUP] 4 [/SUP], Judith A Shovel[SUP] 3 [/SUP], Debbie Albin[SUP] 5 [/SUP], Oscar C Marroquin[SUP] 6 [/SUP], Mark Schmidhofer[SUP] 7 [/SUP], Mary Kay Wisniewski[SUP] 3 [/SUP], David A Nace[SUP] 8 [/SUP], Colleen Sullivan[SUP] 9 [/SUP], Meredith Axe[SUP] 4 [/SUP], Russell Meyer[SUP] 4 [/SUP], Tina Khadem[SUP] 2 [/SUP], William Garrard[SUP] 6 [/SUP], Kevin Collins[SUP] 6 [/SUP], Alan Wells[SUP] 10 [/SUP], Robert D Bart[SUP] 11 [/SUP], Kelsey Linstrum[SUP] 12 [/SUP], Stephanie K Montgomery[SUP] 12 [/SUP], Ghady Haidar[SUP] 2 [/SUP], Graham M Snyder[SUP] 2 [/SUP], Bryan J McVerry[SUP] 13 [/SUP], Christopher W Seymour[SUP] 14 [/SUP], Donald M Yealy[SUP] 4 [/SUP], David T Huang[SUP] 15 [/SUP], Derek C Angus[SUP] 14 [/SUP]
Affiliations
- PMID: 34896293
- DOI: 10.1016/j.cct.2021.106652
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.