Design of VA CoronavirUs Research and Efficacy Studies-1 (VA CURES-1): A double-blind, randomized placebo-controlled trial of COVID-19 convalescent plasma in hospitalized patients with early respiratory compromise

Janoff, Edward N.; Brown, Sheldon T.; Belitskaya-Lévy, Ilana; Curtis, Jeffrey L.; Miller, Elliott K.; Goldberg, Alexa; Zehm, Lisa; Wills, Ashlea; Hutchinson, Caitlin; Dumont, Larry J.; Gleason, Theresa; Shih, Mei‐Chiung

doi:10.1016/j.conctc.2023.101190

Contemporary Clinical Trials Communications

2023

DOI: 10.1016/j.conctc.2023.101190

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Design of VA CoronavirUs Research and Efficacy Studies-1 (VA CURES-1): A double-blind, randomized placebo-controlled trial of COVID-19 convalescent plasma in hospitalized patients with early respiratory compromise

Edward N. Janoff

Sheldon T. Brown

Ilana Belitskaya-Lévy

et al.

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2024

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Creating a plasma coordination center to support COVID-19 outpatient trials across a national network of hospital blood banks

Yarava,

Marshall,

Reichert

et al. 2024

J. Clin. Trans. Sci.

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Introduction: In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety. Methods: A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites. Results: We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites. Conclusion: The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.

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Creating a plasma coordination center to support COVID-19 outpatient trials across a national network of hospital blood banks

Yarava,

Marshall,

Reichert

et al. 2024

J. Clin. Trans. Sci.

View full text Add to dashboard Cite

show abstract

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Design of VA CoronavirUs Research and Efficacy Studies-1 (VA CURES-1): A double-blind, randomized placebo-controlled trial of COVID-19 convalescent plasma in hospitalized patients with early respiratory compromise

Cited by 1 publication

References 52 publications

Creating a plasma coordination center to support COVID-19 outpatient trials across a national network of hospital blood banks

Creating a plasma coordination center to support COVID-19 outpatient trials across a national network of hospital blood banks

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