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

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; Hendrickson, Jeanne E
Importance/UNASSIGNED:There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19. Objective/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED:A unit of approximately 250 mL of CCP or equivalent volume of placebo (normal saline). Main Outcomes and Measures/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04364737.
PMID: 34901997
ISSN: 2168-6114
CID: 5084962

Maintaining adequate donations and a sustainable blood supply: Lessons learned

Gammon, Richard R; Rosenbaum, Lizabeth; Cooke, Rhonda; Friedman, Mark; Rockwood, Linda; Nichols, Tracie; Vossoughi, Sarah
BACKGROUND:The availability of a safe blood supply is a key component of transfusion medicine. A decade of decreased blood use, decreased payment for products, and a dwindling donor base have placed the sustainability of the US blood supply at risk. STUDY DESIGN AND METHODS/METHODS:A literature review was performed for blood center (BC) and hospital disaster management, chronically transfusion-dependent diseases, and appropriate use of group O-negative red blood cells (RBCs), and the Choosing Wisely campaign. The aim was to identify current practice and to make recommendations for BC and hospital actions. RESULTS:While BCs are better prepared to handle disasters than after the 9/11 attacks, messaging to the public remains difficult, as donors often do not realize that blood transfused during a disaster was likely collected before the event. BCs and transfusion services should participate in drafting disaster response plans. Hospitals should maintain inventories adequate for patients in the event supply is disrupted. Providing specialty products for transfusion-dependent patients can strain collections, lead to increased use of group O RBCs, and create logistical inventory challenges for hospitals. The AABB Choosing Wisely initiative addresses overuse of blood components to optimally use this precious resource. Group O-negative RBCs should be transfused only to patients who truly need them. CONCLUSIONS:Collecting and maintaining a blood supply robust enough to handle disasters and transfusion-dependent patients in need of specialty products is challenging. Collaboration of all parties should help to optimize resources, ensure appropriate collections, improve patient care, and ultimately result in a robust, sustainable blood supply.
PMCID:7753343
PMID: 33206404
ISSN: 1537-2995
CID: 4734662

Restructuring Resident Teaching Curriculum: An Institutional Experience [Meeting Abstract]

Mannan, Abul Ala Syed Rifat; Mani, Malary; Prajapati, Shyam; Madrigal, Emilio; Friedman, Mark T.
ISI:000394467300556
ISSN: 0893-3952
CID: 4591762

Restructuring Resident Teaching Curriculum: An Institutional Experience [Meeting Abstract]

Mannan, Abul Ala Syed Rifat; Mani, Malary; Prajapati, Shyam; Madrigal, Emilio; Friedman, Mark T.
ISI:000393724400555
ISSN: 0023-6837
CID: 4591772

Informed consent for blood transfusion and the Joint Commission: the authors' reply [Comment]

Friedman, Mark T; Vergara, Norge
PMID: 23720869
ISSN: 1943-7722
CID: 4591752

Adequacy of physician documentation of red blood cell transfusion and correlation with assessment of transfusion appropriateness

Friedman, Mark T; Ebrahim, Amber
CONTEXT/BACKGROUND:A major function of the hospital transfusion service is to assess the appropriateness of blood transfusion. Inadequate documentation of transfusions may hamper this assessment process. OBJECTIVE:To correlate the level of physician documentation of transfusion with the ability to justify transfusion. DESIGN/METHODS:Retrospective review of red blood cell transfusions in adult patients in 2 hospital facilities during 1-week audit periods of each month from April 2001 to March 2003. Assessment forms were used to classify the level of physician documentation of transfusions into 3 groups: adequately, intermediately, and inadequately documented. Transfusions were deemed justified or not via comparison with hospital transfusion guidelines. RESULTS:There were 5062 audited red blood cells transfused to 2044 adult (> or = 18 years) patients. Medical records from 154 patients transfused with 257 units of red blood cells during 172 transfusion events were reviewed after initial screenings of hemoglobin/hematocrit values failed to justify the transfusions. Nine percent of adequately documented, 50% of intermediately documented, and 73% of inadequately documented transfusion events could not be justified. Transfusion events with suboptimal (intermediate and inadequate) documentation accounted for 49% of all medical record-reviewed transfusion events and 62% could not be justified. The correlation between inadequate documentation and failure to justify transfusion was significant (P < .001), as was the correlation between suboptimal documentation and failure to justify transfusion (P = .03). CONCLUSIONS:There is a significant correlation between suboptimal documentation and failure to justify transfusions. Educating clinicians to improve documentation along with appropriate indications for transfusions may enhance efficiency of blood utilization assessment and lead to reduced rates of unjustifiable transfusions.
PMID: 16594741
ISSN: 1543-2165
CID: 4591742