The UPMC OPTIMISE-C19 (OPtimizing Treatment and Impact of Monoclonal antIbodieS through Evaluation for COVID-19) trial: a structured summary of a study protocol for an open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomization

The primary objective is to evaluate the comparative effectiveness of COVID-19 specific monoclonal antibodies (mABs) with US Food and Drug Administration (FDA) Emergency Use Authorization (EUA), alongside UPMC Health System efforts to increase patient access to these mABs. Open-label, pragmatic, com...

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Veröffentlicht in:Current controlled trials in cardiovascular medicine 2021-05, Vol.22 (1), p.363-3, Article 363
Hauptverfasser: Huang, David T., McCreary, Erin K., Bariola, J. Ryan, Wadas, Richard J., Kip, Kevin E., Marroquin, Oscar C., Koscumb, Stephen, Collins, Kevin, Shovel, Judith A., Schmidhofer, Mark, Wisniewski, Mary Kay, Sullivan, Colleen, Yealy, Donald M., Axe, Meredith, Nace, David A., Haidar, Ghady, Khadem, Tina, Linstrum, Kelsey, Snyder, Graham M., Seymour, Christopher W., Montgomery, Stephanie K., McVerry, Bryan J., Berry, Lindsay, Berry, Scott, Meyers, Russell, Weissman, Alexandra, Peck-Palmer, Octavia M., Wells, Alan, Bart, Robert, Albin, Debbie L., Minnier, Tami, Angus, Derek C.
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Sprache:eng
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Zusammenfassung:The primary objective is to evaluate the comparative effectiveness of COVID-19 specific monoclonal antibodies (mABs) with US Food and Drug Administration (FDA) Emergency Use Authorization (EUA), alongside UPMC Health System efforts to increase patient access to these mABs. Open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomization PARTICIPANTS: We will evaluate patients who meet the eligibility criteria stipulated by the COVID-19 mAB EUAs who receive mABs within the UPMC Health System, including infusion centers and emergency departments. EUA eligibility criteria include patients with mild to moderate COVID-19,
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-021-05316-3