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

Erin K McCreary1, J Ryan Bariola1, Tami Minnier2

  • 1Division of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

Contemporary Clinical Trials
|December 13, 2021
PubMed

Insights

Rapidly launched adaptive trials provided equitable access to monoclonal antibody (mAb) treatments for COVID-19, reducing disparities. This approach ensured timely and fair distribution of vital outpatient therapies.

Area of Science:

  • Infectious Diseases
  • Clinical Trials
  • Health Equity

Background:

  • Outpatient treatments are crucial for preventing severe COVID-19.
  • Monoclonal antibodies (mAbs) reduce hospitalizations but face access and education barriers.
  • Comparative efficacy and safety data for available mAbs are lacking.

Purpose of the Study:

  • To rapidly implement an adaptive platform trial for COVID-19 outpatient treatments.
  • To enhance equitable access to monoclonal antibody (mAb) therapy.
  • To evaluate the comparative efficacy and safety of available mAbs.

Main Methods:

  • An adaptive platform trial was designed and launched within 21 days.
  • Treatment allocation was integrated within the trial infrastructure.
  • Patient access was monitored across different demographics.

Main Results:

  • Equitable access to mAb treatment was achieved within two months, closing racial disparities.
  • The likelihood of receiving mAb treatment became similar for Black and White patients.
  • Trial infrastructure facilitated rapid deployment and access.

Conclusions:

  • Adaptive platform trials can quickly enhance access to critical outpatient treatments like mAbs.
  • This model addresses geographical and socioeconomic barriers to care.
  • Future research should focus on comparative mAb efficacy and safety within such trials.

Keywords:
BamlanivimabCOVID-19CasirivimabEtesevimabImdevimabMonoclonal antibodiesSARS-CoV-2

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