Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days.
Bamlanivimab
COVID-19
Casirivimab
Etesevimab
Imdevimab
Monoclonal antibodies
SARS-CoV-2
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
received:
18
06
2021
revised:
04
12
2021
accepted:
05
12
2021
pubmed:
14
12
2021
medline:
17
2
2022
entrez:
13
12
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 34896293
pii: S1551-7144(21)00388-8
doi: 10.1016/j.cct.2021.106652
pmc: PMC8654455
pii:
doi:
Substances chimiques
Antibodies, Monoclonal
0
Antibodies, Monoclonal, Humanized
0
Antineoplastic Agents, Immunological
0
Types de publication
Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
106652Subventions
Organisme : NIGMS NIH HHS
ID : R35 GM119519
Pays : United States
Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.
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