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3 results on '"Cobb, Gia F."'

1. COVID-19 Convalescent Plasma Therapy: Long-term Implications.

Author

Yoon, Hyunah, Li, Yi, Goldfeld, Keith S, Cobb, Gia F, Sturm-Reganato, Caroline L, Ostrosky-Zeichner, Luis, Jayaweera, Dushyantha T, Philley, Julie V, Desruisseaux, Mahalia S, Keller, Marla J, Hochman, Judith S, Pirofski, Liise-anne, Ortigoza, Mila B, and Group, for the CONTAIN-Extend Study

Subjects
SARS-CoV-2, CONVALESCENT plasma, CORONAVIRUS diseases, COVID-19
Abstract

Background The long-term effect of coronavirus disease 2019 (COVID-19) acute treatments on postacute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) is unknown. The CONTAIN-Extend study explores the long-term impact of COVID-19 convalescent plasma (CCP) therapy on postacute sequelae of SARS-CoV-2 infection (PASC) symptoms and general health 18 months following hospitalization. Methods The CONTAIN-Extend study examined 281 participants from the original CONTAIN COVID-19 trial (CONTAIN-RCT, NCT04364737) at 18 months post–hospitalization for acute COVID-19. Symptom surveys, global health assessments, and biospecimen collection were performed from November 2021 to October 2022. Multivariable logistic and linear regression estimated associations between the randomization arms and self-reported symptoms and Patient-Reported Outcomes Measurement Information System (PROMIS) scores and adjusted for covariables, including age, sex, race/ethnicity, disease severity, and CONTAIN enrollment quarter and sites. Results There were no differences in symptoms or PROMIS scores between CCP and placebo (adjusted odds ratio [aOR] of general symptoms, 0.95; 95% CI, 0.54–1.67). However, females (aOR, 3.01; 95% CI, 1.73–5.34), those 45–64 years (aOR, 2.55; 95% CI, 1.14–6.23), and April–June 2020 enrollees (aOR, 2.39; 95% CI, 1.10–5.19) were more likely to report general symptoms and have poorer PROMIS physical health scores than their respective reference groups. Hispanic participants (difference, −3.05; 95% CI, −5.82 to −0.27) and Black participants (−4.48; 95% CI, −7.94 to −1.02) had poorer PROMIS physical health than White participants. Conclusions CCP demonstrated no lasting effect on PASC symptoms or overall health in comparison to the placebo. This study underscores the significance of demographic factors, including sex, age, and timing of acute infection, in influencing symptom reporting 18 months after acute hypoxic COVID-19 hospitalization. [ABSTRACT FROM AUTHOR]

Published
2024
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2. 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

3. 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., and Desruisseaux, Mahalia S.

Published
2022
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