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13. Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients

Author

Ortigoza, Mila B., Yoon, Hyunah, Goldfeld, Keith S., Troxel, Andrea B., Daily, Johanna P., Wu, Yinxiang, Li, Yi, Wu, Danni, Cobb, Gia F., Baptiste, Gillian, O’Keeffe, Mary, Corpuz, Marilou O., Ostrosky-Zeichner, Luis, Amin, Amee, Zacharioudakis, Ioannis M., Jayaweera, Dushyantha T., Wu, Yanyun, Philley, Julie V., Devine, Megan S., Desruisseaux, Mahalia S., Santin, Alessandro D., Anjan, Shweta, Mathew, Reeba, Patel, Bela, Nigo, Masayuki, Upadhyay, Rabi, Kupferman, Tania, Dentino, Andrew N., Nanchal, Rahul, Merlo, Christian A., Hager, David N., Chandran, Kartik, Lai, Jonathan R., Rivera, Johanna, Bikash, Chowdhury R., Lasso, Gorka, Hilbert, Timothy P., Paroder, Monika, Asencio, Andrea A., Liu, Mengling, Petkova, Eva, Bragat, Alexander, Shaker, Reza, McPherson, David D., Sacco, Ralph L., Keller, Marla J., Grudzen, Corita R., Hochman, Judith S., Pirofski, Liise-anne, Parameswaran, Lalitha, Corcoran, Anthony T., Rohatgi, Abhinav, Wronska, Marta W., Wu, Xinyuan, Srinivasan, Ranjini, Deng, Fang-Ming, Filardo, Thomas D., Pendse, Jay, Blaser, Simone B., Whyte, Olga, Gallagher, Jacqueline M., Thomas, Ololade E., Ramos, Danibel, Sturm-Reganato, Caroline L., Fong, Charlotte C., Daus, Ivy M., Payoen, Arianne Gisselle, Chiofolo, Joseph T., Friedman, Mark T., Wu, Ding Wen, Jacobson, Jessica L., Schneider, Jeffrey G., Sarwar, Uzma N., Wang, Henry E., Huebinger, Ryan M., Dronavalli, Goutham, Bai, Yu, Grimes, Carolyn Z., Eldin, Karen W., Umana, Virginia E, Martin, Jessica G., Heath, Timothy R., Bello, Fatimah O., Ransford, Daru Lane, Laurent-Rolle, Maudry, Shenoi, Sheela V., Akide-Ndunge, Oscar Bate, Thapa, Bipin, Peterson, Jennifer L., Knauf, Kelly, Patel, Shivani U., Cheney, Laura L., Tormey, Christopher A., and Hendrickson, Jeanne E.

Subjects
musculoskeletal diseases, Adult, Male, Research, Critical Illness, Immunization, Passive, COVID-19, Blood Component Transfusion, Middle Aged, Respiration, Artificial, United States, Hospitalization, Treatment Outcome, Double-Blind Method, immune system diseases, Online First, Humans, Female, skin and connective tissue diseases, COVID-19 Serotherapy, Original Investigation, Aged
Abstract

Key Points Question Does COVID-19 convalescent plasma (CCP), compared with placebo, improve the clinical status of hospitalized patients with COVID-19 requiring noninvasive supplemental oxygen? Findings In this randomized clinical trial including 941 patients, based on the World Health Organization 11-point Ordinal Scale for Clinical Improvement, CCP did not benefit 468 participants randomized to CCP compared with 473 randomized to placebo from April 2020 to March 2021. However, in exploratory analyses, CCP appeared to benefit those enrolled from April to June 2020, the period when most participants received high-titer CCP and were not receiving remdesivir and corticosteroids at randomization. Meaning In this trial, CCP did not meet prespecified outcomes for efficacy, but high-titer CCP may have benefited hospitalized patients with COVID-19 early in the pandemic when other treatments were not in use, suggesting a heterogenous treatment effect over time., Importance There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19. Objective To determine the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen. Design, Setting, and Participants CONTAIN COVID-19, a randomized, double-blind, placebo-controlled trial of CCP in hospitalized adults with COVID-19, was conducted at 21 US hospitals from April 17, 2020, to March 15, 2021. The trial enrolled 941 participants who were hospitalized for 3 or less days or presented 7 or less days after symptom onset and required noninvasive oxygen supplementation. Interventions A unit of approximately 250 mL of CCP or equivalent volume of placebo (normal saline). Main Outcomes and Measures The primary outcome was participant scores on the 11-point World Health Organization (WHO) Ordinal Scale for Clinical Improvement on day 14 after randomization; the secondary outcome was WHO scores determined on day 28. Subgroups were analyzed with respect to age, baseline WHO score, concomitant medications, symptom duration, CCP SARS-CoV-2 titer, baseline SARS-CoV-2 serostatus, and enrollment quarter. Outcomes were analyzed using a bayesian proportional cumulative odds model. Efficacy of CCP was defined as a cumulative adjusted odds ratio (cOR) less than 1 and a clinically meaningful effect as cOR less than 0.8. Results Of 941 participants randomized (473 to placebo and 468 to CCP), 556 were men (59.1%); median age was 63 years (IQR, 52-73); 373 (39.6%) were Hispanic and 132 (14.0%) were non-Hispanic Black. The cOR for the primary outcome adjusted for site, baseline risk, WHO score, age, sex, and symptom duration was 0.94 (95% credible interval [CrI], 0.75-1.18) with posterior probability (P[cOR, This randomized clinical trial examines the use of convalescent plasma from patients with COVID-19 in hospitalized patients with COVID-19 who are not receiving invasive oxygenation treatment.

Published
2021

26. Reply by Authors

Author

Werneburg, Glenn T., primary, Nguyen, Anh, additional, Henderson, Nadine S., additional, Rackley, Raymond R., additional, Shoskes, Daniel A., additional, Le Sueur, Amanda L., additional, Corcoran, Anthony T., additional, Katz, Aaron E., additional, Kim, Jason, additional, Rohan, Annie J., additional, and Thanassi, David G., additional

Published
2020
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27. The Natural History and Composition of Urinary Catheter Biofilms: Early Uropathogen Colonization with Intraluminal and Distal Predominance

Author

Werneburg, Glenn T., primary, Nguyen, Anh, additional, Henderson, Nadine S., additional, Rackley, Raymond R., additional, Shoskes, Daniel A., additional, Le Sueur, Amanda L., additional, Corcoran, Anthony T., additional, Katz, Aaron E., additional, Kim, Jason, additional, Rohan, Annie J., additional, and Thanassi, David G., additional

Published
2020
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31. Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients: A Randomized Clinical Trial

Author

Ortigoza, Mila B., Yoon, Hyunah, Goldfeld, Keith S., Troxel, Andrea B., Daily, Johanna P., Wu, Yinxiang, Li, Yi, Wu, Danni, Cobb, Gia F., Baptiste, Gillian, O’Keeffe, Mary, Corpuz, Marilou O., Ostrosky-Zeichner, Luis, Amin, Amee, Zacharioudakis, Ioannis M., Jayaweera, Dushyantha T., Wu, Yanyun, Philley, Julie V., Devine, Megan S., Desruisseaux, Mahalia S., Santin, Alessandro D., Anjan, Shweta, Mathew, Reeba, Patel, Bela, Nigo, Masayuki, Upadhyay, Rabi, Kupferman, Tania, Dentino, Andrew N., Nanchal, Rahul, Merlo, Christian A., Hager, David N., Chandran, Kartik, Lai, Jonathan R., Rivera, Johanna, Bikash, Chowdhury R., Lasso, Gorka, Hilbert, Timothy P., Paroder, Monika, Asencio, Andrea A., Liu, Mengling, Petkova, Eva, Bragat, Alexander, Shaker, Reza, McPherson, David D., Sacco, Ralph L., Keller, Marla J., Grudzen, Corita R., Hochman, Judith S., Pirofski, Liise-anne, Parameswaran, Lalitha, Corcoran, Anthony T., Rohatgi, Abhinav, Wronska, Marta W., Wu, Xinyuan, Srinivasan, Ranjini, Deng, Fang-Ming, Filardo, Thomas D., Pendse, Jay, Blaser, Simone B., Whyte, Olga, Gallagher, Jacqueline M., Thomas, Ololade E., Ramos, Danibel, Sturm-Reganato, Caroline L., Fong, Charlotte C., Daus, Ivy M., Payoen, Arianne Gisselle, Chiofolo, Joseph T., Friedman, Mark T., Wu, Ding Wen, Jacobson, Jessica L., Schneider, Jeffrey G., Sarwar, Uzma N., Wang, Henry E., Huebinger, Ryan M., Dronavalli, Goutham, Bai, Yu, Grimes, Carolyn Z., Eldin, Karen W., Umana, Virginia E, Martin, Jessica G., Heath, Timothy R., Bello, Fatimah O., Ransford, Daru Lane, Laurent-Rolle, Maudry, Shenoi, Sheela V., Akide-Ndunge, Oscar Bate, Thapa, Bipin, Peterson, Jennifer L., Knauf, Kelly, Patel, Shivani U., Cheney, Laura L., Tormey, Christopher A., and Hendrickson, Jeanne E.

Abstract

IMPORTANCE: There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19. OBJECTIVE: To determine the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen. DESIGN, SETTING, AND PARTICIPANTS: CONTAIN COVID-19, a randomized, double-blind, placebo-controlled trial of CCP in hospitalized adults with COVID-19, was conducted at 21 US hospitals from April 17, 2020, to March 15, 2021. The trial enrolled 941 participants who were hospitalized for 3 or less days or presented 7 or less days after symptom onset and required noninvasive oxygen supplementation. INTERVENTIONS: A unit of approximately 250 mL of CCP or equivalent volume of placebo (normal saline). MAIN OUTCOMES AND MEASURES: The primary outcome was participant scores on the 11-point World Health Organization (WHO) Ordinal Scale for Clinical Improvement on day 14 after randomization; the secondary outcome was WHO scores determined on day 28. Subgroups were analyzed with respect to age, baseline WHO score, concomitant medications, symptom duration, CCP SARS-CoV-2 titer, baseline SARS-CoV-2 serostatus, and enrollment quarter. Outcomes were analyzed using a bayesian proportional cumulative odds model. Efficacy of CCP was defined as a cumulative adjusted odds ratio (cOR) less than 1 and a clinically meaningful effect as cOR less than 0.8. RESULTS: Of 941 participants randomized (473 to placebo and 468 to CCP), 556 were men (59.1%); median age was 63 years (IQR, 52-73); 373 (39.6%) were Hispanic and 132 (14.0%) were non-Hispanic Black. The cOR for the primary outcome adjusted for site, baseline risk, WHO score, age, sex, and symptom duration was 0.94 (95% credible interval [CrI], 0.75-1.18) with posterior probability (P[cOR<1] = 72%); the cOR for the secondary adjusted outcome was 0.92 (95% CrI, 0.74-1.16; P[cOR<1] = 76%). Exploratory subgroup analyses suggested heterogeneity of treatment effect: at day 28, cORs were 0.72 (95% CrI, 0.46-1.13; P[cOR<1] = 93%) for participants enrolled in April-June 2020 and 0.65 (95% CrI, 0.41 to 1.02; P[cOR<1] = 97%) for those not receiving remdesivir and not receiving corticosteroids at randomization. Median CCP SARS-CoV-2 neutralizing titer used in April to June 2020 was 1:175 (IQR, 76-379). Any adverse events (excluding transfusion reactions) were reported for 39 (8.2%) placebo recipients and 44 (9.4%) CCP recipients (P = .57). Transfusion reactions occurred in 2 (0.4) placebo recipients and 8 (1.7) CCP recipients (P = .06). CONCLUSIONS AND RELEVANCE: In this trial, CCP did not meet the prespecified primary and secondary outcomes for CCP efficacy. However, high-titer CCP may have benefited participants early in the pandemic when remdesivir and corticosteroids were not in use. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04364737

Published
2022
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32. Effects of focal versus total cryotherapy and minimum tumor temperature on patient-reported quality of life as compared to active surveillance in prostate cancer patients

Author

Werneburg, Glenn T., Kongnyuy, Michael, Halpern, Daniel M., Salcedo, Jose M., Chen, Connie, LeSueur, Amanda, Kosinski, Kaitlin E., Schiff, Jeffrey T., Corcoran, Anthony T., and Katz, Aaron E.

Subjects
Article
Abstract

OBJECTIVE: To investigate the effects of focal (hemiablation) or total cryotherapy and minimum tumor temperature on patient-reported quality of life (QoL) in prostate cancer patients. METHODS: An IRB-approved database was reviewed for patients who underwent cryotherapy or active surveillance (AS). QoL questionnaire responses were collected and scores were analyzed for differences between focal versus total cryotherapy and very cold (

Published
2017

35. MP30-09 MODERATE MINIMUM TUMOR TEMPERATURE IN CRYOTHERAPY IS ASSOCIATED WITH SUPERIOR QUALITY OF LIFE AND NO DIFFERENCE IN DISEASE CONTROL IN PROSTATE CANCER PATIENTS

Author

Werneburg, Glenn T., primary, Kongnyuy, Michael, additional, Halpern, Daniel M., additional, Salcedo, Jose M., additional, Chen, Connie, additional, LeSueur, Amanda L., additional, Kosinski, Kaitlin E., additional, Schiff, Jeffrey T., additional, Corcoran, Anthony T., additional, and Katz, Aaron E., additional

Published
2018
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38. MP30-12 FOCAL CRYOABLATION IS ASSOCIATED WITH SUPERIOR QUALITY OF LIFE AND NO DIFFERENCE IN DISEASE CONTROL RELATIVE TO TOTAL CRYOABLATION IN PROSTATE CANCER PATIENTS

Author

Werneburg, Glenn T., primary, Kongnyuy, Michael, additional, Halpern, Daniel M., additional, Salcedo, Jose M., additional, Chen, Connie, additional, LeSueur, Amanda L., additional, Kosinski, Kaitlin E., additional, Schiff, Jeffrey T., additional, Corcoran, Anthony T., additional, and Katz, Aaron E., additional

Published
2018
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42. Hyperthermia and intravesical therapy: emerging one-two punch for bladder cancer?

Author

Corcoran, Anthony T. and Gingrich, Jeffrey R.

Subjects
Bladder cancer -- Development and progression -- Care and treatment -- Research, Thermotherapy -- Health aspects, Chemotherapy -- Health aspects, Cancer -- Chemotherapy, Health
Abstract

Bladder cancer is the fourth most common cancer (excluding skin cancer) in the United States and ranks eighth as a cause of death from cancer among men; there will be [...]

Published
2010

43. Nephron-sparing management vs radical nephroureterectomy for low- or moderate-grade, low-stage upper tract urothelial carcinoma

Author

Simhan, Jay, Smaldone, Marc C., Egleston, Brian L., Canter, Daniel, Sterious, Steven N., Corcoran, Anthony T., Ginzburg, Serge, Uzzo, Robert G., and Kutikov, Alexander

Subjects
Aged, 80 and over, Male, Ureteral Neoplasms, Nephrons, Middle Aged, Nephrectomy, Article, Cohort Studies, Survival Rate, Treatment Outcome, Humans, Female, Neoplasm Grading, Urothelium, Organ Sparing Treatments, Aged, Neoplasm Staging, SEER Program
Abstract

To compare overall and cancer-specific outcomes between patients with upper tract urothelial carcinoma (UTUC) managed with either radical nephroureterectomy (RNU) or nephron-sparing measures (NSM) using a large population-based dataset.Using Surveillance, Epidemiology, and End Results (SEER) data, patients diagnosed with low- or moderate-grade, localised non-invasive UTUC were stratified into two groups: those treated with RNU or NSM (observation, endoscopic ablation, or segmental ureterectomy). Cancer-specific mortality (CSM) and other-cause mortality (OCM) rates were determined using cumulative incidence estimators. Adjusting for clinical and pathological characteristics, the associations between surgical type, all-cause mortality and CSM were tested using Cox regressions and Fine and Gray regressions, respectively.Of 1227 patients [mean (sd) age 70.2 (11.00) years, 63.2% male] meeting inclusion criteria, 907 (73.9%) and 320 (26.1%) patients underwent RNU and NSM for low- or moderate-grade, low-stage UTUC from 1992 to 2008. Patients undergoing NSM were older (mean age 71.6 vs 69.7 years, P0.01) with a greater proportion of well-differentiated tumours (26.3% vs 18.0%, P = 0.001). While there were differences in OCM between the groups (P0.01), CSM trends were equivalent. After adjustment, RNU treatment was associated with improved non-cancer cause survival [hazard ratio (HR) 0.78, confidence interval [CI] 0.64-0.94) while no association with CSM was demonstrable (HR 0.89, CI 0.63-1.26).Patients with low- or moderate-grade, low-stage UTUC managed through NSM are older and are more likely to die of other causes, but they have similar CSM rates to those patients managed with RNU. These data may be useful when counselling patients with UTUC with significant competing comorbidities.

Published
2013

44. PSA kinetics following primary focal cryotherapy (hemiablation) in organ-confined prostate cancer patients.

Author

Kongnyuy, Michael, Islam, Shahidul, Mbah, Alfred K., Halpern, Daniel M., Werneburg, Glenn T., Kosinski, Kaitlin E., Chen, Connie, Habibian, David J., Schiff, Jeffrey T., Corcoran, Anthony T., and Katz, Aaron E.

Subjects
PROSTATE-specific antigen, COLD therapy, PROSTATE cancer patients, PROSTATE cancer treatment, CANCER relapse
Abstract

Purpose: We aim to evaluate prostate-specific antigen (PSA) trends in post-primary focal cryotherapy (PFC) patients.Materials and methods: This was an institutional review board-approved retrospective study of PFC patients from 2010 to 2015. Patients with at least one post-PFC PSA were included in the study. Biochemical recurrence (BCR) was determined using the Phoenix criteria. PSA bounce was also assessed. We analyzed rates of change of PSA over time of post-PFC between BCR and no BCR groups. PSA-derived variables were analyzed as potential predictors of BCR.Results: A total of 104 PFC patients were included in our analysis. Median (range) age and follow-up time were 66 (48–82) years and 19 (6.3–38.6) months, respectively. Four (3.8%) patients experienced PSA bounce. The median percent drop in first post-PFC PSA of 80.0% was not associated with BCR (p = 0.256) and may indicate elimination of the index lesion. The rate of increase of PSA in BCR patients was significantly higher compared to patients who did not recur (median PSA velocity (PSAV): 0.15 vs 0.04 ng/ml/month, p = 0.001). Similar to PSAV (HR 9.570, 95% CI 3.725–24.592, p < 0.0001), PSA nadir ≥ 2 ng/ml [HR (hazard ratio) 1.251, 95% CI 1.100–1.422, p = 0.001] was independently associated with BCR.Conclusion: A significant drop in post-PFC PSA may indicate elimination of the index lesion. Patients who are likely to recur biochemically have a significantly higher PSAV compared to those who do not recur. Nadir PSA of less than 2 ng/ml may be considered the new normal PSA in focal cryotherapy (hemiablation) follow-up. [ABSTRACT FROM AUTHOR]

Published
2018
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47. Hypoalbuminaemia is associated with mortality in patients undergoing cytoreductive nephrectomy

Author

Corcoran, Anthony T., primary, Kaffenberger, Samuel D., additional, Clark, Peter E., additional, Walton, John, additional, Handorf, Elizabeth, additional, Piotrowski, Zack, additional, Tomaszewski, Jeffery J., additional, Ginzburg, Serge, additional, Mehrazin, Reza, additional, Plimack, Elizabeth, additional, Chen, David Y.T., additional, Smaldone, Marc C., additional, Uzzo, Robert G., additional, Morgan, Todd M., additional, and Kutikov, Alexander, additional

Published
2014
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48. Coupling of Prostate and Thyroid Cancer Diagnoses in the United States

Author

Tomaszewski, Jeffrey J., primary, Uzzo, Robert G., additional, Egleston, Brian, additional, Corcoran, Anthony T., additional, Mehrazin, Reza, additional, Geynisman, Daniel M., additional, Ridge, John A., additional, Veloski, Colleen, additional, Kocher, Neil, additional, Smaldone, Marc C., additional, and Kutikov, Alexander, additional

Published
2014
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