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

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 bar...

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Autores principales: McCreary, Erin K., Bariola, J. Ryan, Minnier, Tami, Wadas, Richard J., Shovel, Judith A., Albin, Debbie, Marroquin, Oscar C., Schmidhofer, Mark, Wisniewski, Mary Kay, Nace, David A., Sullivan, Colleen, Axe, Meredith, Meyers, Russell, Khadem, Tina, Garrard, William, Collins, Kevin, Wells, Alan, Bart, Robert D., Linstrum, Kelsey, Montgomery, Stephanie K., Haidar, Ghady, Snyder, Graham M., McVerry, Bryan J., Seymour, Christopher W., Yealy, Donald M., Huang, David T., Angus, Derek C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Authors. Published by Elsevier Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8654455/
https://www.ncbi.nlm.nih.gov/pubmed/34896293
http://dx.doi.org/10.1016/j.cct.2021.106652
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author McCreary, Erin K.
Bariola, J. Ryan
Minnier, Tami
Wadas, Richard J.
Shovel, Judith A.
Albin, Debbie
Marroquin, Oscar C.
Schmidhofer, Mark
Wisniewski, Mary Kay
Nace, David A.
Sullivan, Colleen
Axe, Meredith
Meyers, Russell
Khadem, Tina
Garrard, William
Collins, Kevin
Wells, Alan
Bart, Robert D.
Linstrum, Kelsey
Montgomery, Stephanie K.
Haidar, Ghady
Snyder, Graham M.
McVerry, Bryan J.
Seymour, Christopher W.
Yealy, Donald M.
Huang, David T.
Angus, Derek C.
author_facet McCreary, Erin K.
Bariola, J. Ryan
Minnier, Tami
Wadas, Richard J.
Shovel, Judith A.
Albin, Debbie
Marroquin, Oscar C.
Schmidhofer, Mark
Wisniewski, Mary Kay
Nace, David A.
Sullivan, Colleen
Axe, Meredith
Meyers, Russell
Khadem, Tina
Garrard, William
Collins, Kevin
Wells, Alan
Bart, Robert D.
Linstrum, Kelsey
Montgomery, Stephanie K.
Haidar, Ghady
Snyder, Graham M.
McVerry, Bryan J.
Seymour, Christopher W.
Yealy, Donald M.
Huang, David T.
Angus, Derek C.
author_sort McCreary, Erin K.
collection PubMed
description 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.
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spelling pubmed-86544552021-12-09 Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days McCreary, Erin K. Bariola, J. Ryan Minnier, Tami Wadas, Richard J. Shovel, Judith A. Albin, Debbie Marroquin, Oscar C. Schmidhofer, Mark Wisniewski, Mary Kay Nace, David A. Sullivan, Colleen Axe, Meredith Meyers, Russell Khadem, Tina Garrard, William Collins, Kevin Wells, Alan Bart, Robert D. Linstrum, Kelsey Montgomery, Stephanie K. Haidar, Ghady Snyder, Graham M. McVerry, Bryan J. Seymour, Christopher W. Yealy, Donald M. Huang, David T. Angus, Derek C. Contemp Clin Trials Article 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. The Authors. Published by Elsevier Inc. 2022-02 2021-12-09 /pmc/articles/PMC8654455/ /pubmed/34896293 http://dx.doi.org/10.1016/j.cct.2021.106652 Text en © 2021 The Authors Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
McCreary, Erin K.
Bariola, J. Ryan
Minnier, Tami
Wadas, Richard J.
Shovel, Judith A.
Albin, Debbie
Marroquin, Oscar C.
Schmidhofer, Mark
Wisniewski, Mary Kay
Nace, David A.
Sullivan, Colleen
Axe, Meredith
Meyers, Russell
Khadem, Tina
Garrard, William
Collins, Kevin
Wells, Alan
Bart, Robert D.
Linstrum, Kelsey
Montgomery, Stephanie K.
Haidar, Ghady
Snyder, Graham M.
McVerry, Bryan J.
Seymour, Christopher W.
Yealy, Donald M.
Huang, David T.
Angus, Derek C.
Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days
title Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days
title_full Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days
title_fullStr Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days
title_full_unstemmed Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days
title_short Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days
title_sort launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for covid-19 in 21 days
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8654455/
https://www.ncbi.nlm.nih.gov/pubmed/34896293
http://dx.doi.org/10.1016/j.cct.2021.106652
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