Notice: Users may be experiencing issues with displaying some pages on stanfordhealthcare.org. We are working closely with our technical teams to resolve the issue as quickly as possible. Thank you for your patience.
 

Learn about the flu shot, COVID-19 vaccine, and our masking policy »

Stanford Health Care

I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations. BMJ open Files, D. C., Matthay, M. A., Calfee, C. S., Aggarwal, N. R., Asare, A. L., Beitler, J. R., Berger, P. A., Burnham, E. L., Cimino, G., Coleman, M. H., Crippa, A., Discacciati, A., Gandotra, S., Gibbs, K. W., Henderson, P. T., Ittner, C. A., Jauregui, A., Khan, K. T., Koff, J. L., Lang, J., LaRose, M., Levitt, J., Lu, R., McKeehan, J. D., Meyer, N. J., Russell, D. W., Thomas, K. W., Eklund, M., Esserman, L. J., Liu, K. D., ISPY COVID Adaptive Platform Trial Network, undefined, Esserman, L. J., Calfee, C. S., Liu, K. D., Coleman, M. H., Matthay, M. A., Beitler, J. R., Mittel, A. M., Asare, A. L., Yen, A. F., Jauregui, A., Crippa, A., Suarez, A. E., Serra, A. L., Amin, A. N., Rosen, A., Dzierba, A. L., Discacciati, A., Haczku, A., Barker, A. D., Weisman, A. R., Daniel, B. M., Morrissey, B. M., Ittner, C. A., Jones, C., Creel-Bulos, C., Angelucci, C. M., Files, D. C., Russell, D. W., Ng, D., Burnham, E. L., Youssef, F. A., Chaparro-Rojas, F., Harris, G. H., Barot, H. V., Su, H., Garcia, I., Sutter, J. B., Dodin, J., McKeehan, J. D., Lee, J. S., Kazianis, J., Reilly, J. P., Koff, J. L., Detelich, J. F., Lang, J. E., Muir, J., Thomas, K. W., Khan, K. T., Gosek, K., Nugent, K. L., Gibbs, K. W., Yee, K., Rodrigues, L. G., Macias, L. R., Orr, L. A., Boerger, L. L., Rosario-Remigio, L., Kufa, L., Huerta, L. E., Tanios, M., Reyes, M. B., Eklund, M., LaRose, M., Adelman, M. W., Juarez, M. M., Jung, M., Meyers, M., Sternlieb, M. P., Cobb, N. K., Aggarwal, N., Mangalmurti, N. S., Meyer, N. J., Jones, P., Berger, P. A., Henderson, P., Saban, P. L., Marshall, P. S., Robinson, P. A., Yang, P., Madahar, P., Nair, R., Sonti, R., Lee, R. A., Wunderink, R. G., Wahab, R., Lupu, R. A., Lu, R., Kumar, S. I., Auld, S. C., Fields, S., Wong, S. F., Gandotra, S., Pearson, S. J., Whealon, S., Albertson, T. E., Obermiller, T. F., Oliver, T., Darmanian, A., Schicchi, J., Martinez, E., Sarafian, F., Nguyen, J., Weiler-Lisowski, B., Wyatt, J., Blevins, D., Melendrez, M., Lopez, B., Tzehaie, H., Amosu, O., Simonson, A., Patel, C., Levitt, J., Hardy, E., Lindgren, B., Peterfreund, G., Landreth, L., Parks, L., Aggarwal, N. 2022; 12 (6): e060664

Abstract

INTRODUCTION: The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalised with severe COVID-19. The Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (ISPY COVID-19 trial) was designed and implemented in early 2020 to evaluate investigational agents rapidly and simultaneously on a phase 2 adaptive platform. This manuscript outlines the design, rationale, implementation and challenges of the ISPY COVID-19 trial during the first phase of trial activity from April 2020 until December 2021.METHODS AND ANALYSIS: The ISPY COVID-19 Trial is a multicentre open-label phase 2 platform trial in the USA designed to evaluate therapeutics that may have a large effect on improving outcomes from severe COVID-19. The ISPY COVID-19 Trial network includes academic and community hospitals with significant geographical diversity across the country. Enrolled patients are randomised to receive one of up to four investigational agents or a control and are evaluated for a family of two primary outcomes-time to recovery and mortality. The statistical design uses a Bayesian model with 'stopping' and 'graduation' criteria designed to efficiently discard ineffective therapies and graduate promising agents for definitive efficacy trials. Each investigational agent arm enrols to a maximum of 125 patients per arm and is compared with concurrent controls. As of December 2021, 11 investigational agent arms had been activated, and 8 arms were complete. Enrolment and adaptation of the trial design are ongoing.ETHICS AND DISSEMINATION: ISPY COVID-19 operates under a central institutional review board via Wake Forest School of Medicine IRB00066805. Data generated from this trial will be reported in peer-reviewed medical journals.TRIAL REGISTRATION NUMBER: NCT04488081.

View details for DOI 10.1136/bmjopen-2021-060664

View details for PubMedID 35667714