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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

Diagnostic and management considerations in the modern patient with AIDS: a case of concurrent disseminated Kaposi sarcoma and colesional Cryptococcus neoformans

Williams, Samuel Clay; Sweeney, Jacob; Parameswaran, Lalitha
In the era of highly active antiretroviral therapy (HAART), disseminated Kaposi sarcoma (KS) has become much rarer in the USA. We report a case of a 34-year-old man with KS of the skin, oropharynx, lung and rectum. Within the same lung nodule, we discovered significant burden of colesional Cryptococcus neoformans, in the context of a positive asymptomatic cryptococcal antigenemia, which was a previously unreported occurrence. The gold standard of treatment for KS continues to be HAART. The role of chemotherapy is still controversial. In addition, a cryptococcal antigen screen-and-treat approach with fluconazole is still not routinely recommended in the USA to prevent serious meningeal disease despite recent studies showing efficacy and applicability. We discuss both issues here and the outcome of our patient. We also present the patient's own unique perspective in dealing with the ramifications of these diagnoses.
PMID: 32295799
ISSN: 1757-790x
CID: 4401392

Septic Shoulder Joint After Pneumococcal Vaccination Requiring Surgical Debridement [Case Report]

DeRogatis, Michael J; Parameswaran, Lalitha; Lee, Patrick; Mayer, Theodore G; Issack, Paul S
PMCID:6148572
PMID: 30258336
ISSN: 1556-3316
CID: 4050412

A Case of Adult Intestinal Toxemia Botulism During Prolonged Hospitalization in an Allogeneic Hematopoietic Cell Transplant Recipient

Parameswaran, Lalitha; Rao, Agam; Chastain, Katherine; Ackelsburg, Joel; Adams, Eleanor; Jackson, Brendan; Voigt, Louis P; Chen, Xi; Boulad, Farid; Taur, Ying
We report a laboratory-confirmed case of adult intestinal toxemia botulism in an allogeneic hematopoietic stem cell transplantation (allo-HCT) recipient. Onset of symptoms occurred within the hospitalized setting, making this case particularly unique. Botulism may have arisen because of significant intestinal disruption and compromise, and not directly from immune compromise.
PMID: 29293935
ISSN: 1537-6591
CID: 4050402

Electrically switchable diffractive waveplates with metasurface aligned liquid crystals

Chou, Jeffrey; Parameswaran, Lalitha; Kimball, Brian; Rothschild, Mordechai
Diffractive waveplates and equivalent metasurfaces provide a promising path for applications in thin film beam steering, tunable lenses, and polarization filters. However, fixed metasurfaces alone are unable to be tuned electronically. By combining metasurfaces with tunable liquid crystals, we experimentally demonstrate a single layer device capable of electrically switching a diffractive waveplate design at a measured peak diffraction efficiency of 35%, and a minimum switching voltage of 10V. Furthermore, the nano-scale metasurface aligned liquid crystals are largely independent of variations in wavelength and temperature. We also present a computational analysis of the efficiency limits of liquid crystal based diffractive waveplates, and compare this analysis to experimental measurements.
PMID: 27828158
ISSN: 1094-4087
CID: 4050392

Prasugrel hypersensitivity with respiratory distress and rash [Case Report]

Kaufman, Michele B; Pham, Tammy; Parameswaran, Lalitha; Choy, Mary
PURPOSE/OBJECTIVE:An adverse drug reaction associated with the use of prasugrel for dual antiplatelet therapy after percutaneous coronary intervention (PCI) with stent placement is reported. SUMMARY/CONCLUSIONS:About one week after starting prasugrel use following angioplasty and a stent revision procedure, a 61-year-old woman arrived in the emergency department with wheezing, shortness of breath, a feeling of throat closure, and a widespread erythematous, maculopapular, pruritic rash. She reported that the respiratory symptoms had started to develop the previous day, with the onset of rash occurring about 24 hours after initiation of prasugrel therapy. The patient's symptoms subsided after administration of 0.3 mg epinephrine subcutaneously, diphenhydramine 50 mg i.v., and methylprednisolone 125 mg i.v. Prasugrel was discontinued, and the patient was switched to another P2Y12 inhibitor (ticagrelor) for continued dual antiplatelet therapy. Analysis of the case using the adverse drug reaction probability scale of Naranjo et al. indicated that prasugrel was the probable cause of the hypersensitivity reaction. Hypersensitivity manifesting as a rash has been previously reported in patients receiving prasugrel, a thienopyridine P2Y12 inhibitor. Desensitization may be an option for thienopyridine-allergic patients undergoing PCI with stenting; alternatively, the nonthienopyridine P2Y12 inhibitor ticagrelor may be used in a dual antiplatelet therapy regimen. CONCLUSION/CONCLUSIONS:A patient who had undergone PCI with stenting developed shortness of breath and rash associated with prasugrel therapy. Symptoms abated after supportive therapy and discontinuation of prasugrel, the probable offending agent. Treatment was safely switched to ticagrelor.
PMID: 27385702
ISSN: 1535-2900
CID: 4050382

Tolerability of chemotherapy in HIV-infected women with breast cancer: are there prognostic implications?

Parameswaran, Lalitha; Taur, Ying; Shah, Monika K; Traina, Tiffany A; Seo, Susan K
Breast cancer is the most commonly diagnosed malignancy in women, but little is known about therapeutic outcomes in patients with both breast cancer and HIV. We performed a retrospective cohort study of women with or without HIV undergoing treatment for breast cancer from 1996 to 2011. Cases with HIV were 1:2 matched to non-HIV controls based on age, sex, race, and date of cancer diagnosis. Dose reduction and/or delay during chemotherapy, overall survival, and development of metastatic disease were studied outcomes. 156 (52 HIV, 104 non-HIV) subjects were analyzed. The majority of breast cancers in both groups were clinical stages 0, I, II, and III (73%). HIV infection preceded cancer diagnosis by a median of 13 years. Median CD4 count at time of cancer diagnosis was 417 cells/mcL. Approximately 87% (45/52) were on HAART, mostly protease inhibitor-based (57%) therapy. HIV-infected women needed more dose reductions and/or delays to chemotherapy due to toxicity (56% vs. 30%; p=0.03). Stage at diagnosis, triple negative receptor status, and dose reduction and/or delay were predictors of metastatic disease and death. HIV-infected women experienced more adverse events during breast cancer treatment, and a potential causative factor could be drug-drug interactions between HAART and chemotherapy.
PMID: 24839993
ISSN: 1557-7449
CID: 4050372

Developing a computer touch-screen interactive colorectal screening decision aid for a low-literacy African American population: lessons learned

Bass, Sarah Bauerle; Gordon, Thomas F; Ruzek, Sheryl Burt; Wolak, Caitlin; Ruggieri, Dominique; Mora, Gabriella; Rovito, Michael J; Britto, Johnson; Parameswaran, Lalitha; Abedin, Zainab; Ward, Stephanie; Paranjape, Anuradha; Lin, Karen; Meyer, Brian; Pitts, Khaliah
African Americans have higher colorectal cancer (CRC) mortality than White Americans and yet have lower rates of CRC screening. Increased screening aids in early detection and higher survival rates. Coupled with low literacy rates, the burden of CRC morbidity and mortality is exacerbated in this population, making it important to develop culturally and literacy appropriate aids to help low-literacy African Americans make informed decisions about CRC screening. This article outlines the development of a low-literacy computer touch-screen colonoscopy decision aid using an innovative marketing method called perceptual mapping and message vector modeling. This method was used to mathematically model key messages for the decision aid, which were then used to modify an existing CRC screening tutorial with different messages. The final tutorial was delivered through computer touch-screen technology to increase access and ease of use for participants. Testing showed users were not only more comfortable with the touch-screen technology but were also significantly more willing to have a colonoscopy compared with a "usual care group." Results confirm the importance of including participants in planning and that the use of these innovative mapping and message design methods can lead to significant CRC screening attitude change.
PMCID:5310576
PMID: 23132838
ISSN: 1524-8399
CID: 4050362

Resident physicians' perceptions of barriers and facilitators to colorectal cancer screening for African Americans

Ward, Stephanie H; Parameswaran, Lalitha; Bass, Sarah B; Paranjape, Anuradha; Gordon, Thomas F; Ruzek, Sheryl Burt
BACKGROUND:African Americans experience disproportionately higher morbidity and mortality from colorectal cancer (CRC), yet they complete screening at lower rates than Caucasians. While studies have identified barriers and facilitators to CRC screening among African Americans, no study has examined physician perceptions of these barriers. OBJECTIVE:The purpose of this study was to determine how resident physicians view barriers and facilitators to CRC screening among their African American patients, and to compare residents' perceptions with barriers and facilitators that have been reported in studies with African Americans. DESIGN/METHODS:Both quantitative and qualitative data were obtained during in-depth interviews with 30 upper-year residents from an urban academic internal medicine program. RESULTS:Residents recognized the low levels of awareness of CRC that have been reported among African American patients. The most common barriers reported by residents were lack of knowledge, fears, personal/social circumstances, and colonoscopy-specific concerns. Residents reported a need for increased education, increased public awareness, and easier scheduling as facilitators for screening. Residents failed to appreciate some key perceptions held by African Americans that have been documented to either impede or facilitate CRC screening completion, particularly the positive beliefs that could be used to overcome some of the perceived barriers. CONCLUSIONS:Residents may be missing opportunities to more effectively communicate about CRC screening with their African American patients. Residents need more explicit education about African Americans' perceptions to successfully promote screening behaviors in this high-risk population.
PMID: 20437737
ISSN: 0027-9684
CID: 4050352

Increasing colorectal cancer screening among African Americans, linking risk perception to interventions targeting patients, communities and clinicians

Ward, Stephanie H; Lin, Karen; Meyer, Brian; Bass, Sarah B; Parameswaran, Lalitha; Gordon, Thomas F; Ruzek, Sheryl Burt
Colorectal cancer (CRC) screening remains significantly underutilized by African Americans despite their increased risk compared to whites. The purpose of this article is to review recent research on patterns of screening, perceptions of CRC screening methods and outcomes of seven intervention trials specifically designed to increase screening among African Americans in light of the recommendation of the American College of Gastroenterologists to make colonoscopy the screening method of choice for this population. This review shows that progress has been made in understanding the complexity of perceived barriers to CRC screening among African Americans. Interventions that used community-based education targeting individuals and clinically based education targeting clinicians showed modest increases in screening rates. Targeting entire communities did not show significant results. However, because intervention studies use not only different types of interventions but different screening outcome measures, results are not easily comparable. While there is growing evidence that interventions can increase the use of fecal occult blood test (FOBT), it is not yet known if similar interventions can increase rates of screening colonoscopy. Clinicians, patients and policymakers also need to consider the array of social, cultural and financial issues associated with CRC screening in African-American communities.
PMID: 18595582
ISSN: 0027-9684
CID: 4050342