Cardiovascular Safety of Azithromycin in Patients Hospitalized With COVID-19: A Prespecified Pooled Analysis of the COALITION I and COALITION II Randomized Clinical Trials

Article

Author: Amazonas, Roberto ; Avezum, Alvaro ; Lisboa, Thiago ; Berwanger, Otavio ; Junqueira, Debora L M ; Serpa-Neto, Ary ; Azevedo, Luciano C P ; Correa, Thiago D ; Polanczyk, Carisi A ; Olivato, Guilherme B ; Fonseca, Henrique A R ; Zampieri, Fernando G ; Furtado, Remo H M ; Monfardini, Frederico ; Veiga, Viviane C ; Lopes, Renato D ; Guimarães, Hélio P ; Pereira, Adriano J ; Hoffman Filho, Conrado R ; Cavalcanti, Alexandre B ; Machado, Flávia R ; Lapa, Maura G ; Rohde, Luis E ; Barros E Silva, Pedro G M ; Gebara, Otavio E ; Echenique, Leandro S ; Damiani, Lucas P ; Rosa, Regis G

The cardiovascular safety from azithromycin in the treatment of several infectious diseases has been challenged. In this prespecified pooled analysis of 2 multicenter randomized clinical trials, we aimed to assess whether the use of azithromycin might lead to corrected QT (QTc) interval prolongation or clinically relevant ventricular arrhythmias. In the COALITION COVID Brazil I trial, 667 patients admitted with moderate COVID-19 were randomly allocated to hydroxychloroquine, hydroxychloroquine plus azithromycin, or standard of care. In the COALITION COVID Brazil II trial, 447 patients with severe COVID-19 were randomly allocated to hydroxychloroquine alone versus hydroxychloroquine plus azithromycin. The principal end point for the present analysis was the composite of death, resuscitated cardiac arrest, or ventricular arrhythmias. The addition of azithromycin to hydroxychloroquine did not result in any prolongation of the QTc interval (425.8 ± 3.6 ms vs 427.9 ± 3.9 ms, respectively, mean difference -2.1 ms, 95% confidence interval -12.5 to 8.4 ms, p = 0.70). The combination of azithromycin plus hydroxychloroquine compared with hydroxychloroquine alone did not result in increased risk of the primary end point (proportion of patients with events at 15 days 17.2% vs 16.0%, respectively, hazard ratio 1.08, 95% confidence interval 0.78 to 1.49, p = 0.65). In conclusion, in patients hospitalized with COVID-19 already receiving standard-of-care management (including hydroxychloroquine), the addition of azithromycin did not result in the prolongation of the QTc interval or increase in cardiovascular adverse events. Because azithromycin is among the most commonly prescribed antimicrobial agents, our results may inform clinical practice. Clinical Trial Registration: NCT04322123, NCT04321278.

19 Nov 2020·New England Journal of MedicineQ1 · MEDICINE

Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19

Q1 · MEDICINE

Article

Author: Serpa-Neto, Ary ; Zampieri, Fernando G ; Berwanger, Otavio ; Rosa, Regis G ; Marcadenti, Aline ; Gebara, Otávio C E ; Hoffmann Filho, Conrado R ; Damiani, Lucas P ; Furtado, Remo H M ; Falavigna, Maicon ; Abreu-Silva, Erlon O ; Soares, Aline T ; Lopes, Renato D ; Lisboa, Thiago ; Amazonas, Roberto B ; Cardoso, Fábio F ; de Barros E Silva, Pedro G M ; Azevedo, Luciano C P ; Veiga, Viviane C ; Echenique, Leandro S ; Laranjeira, Ligia N ; Kawano-Dourado, Letícia ; Pereira, Adriano J ; Bocchi de Oliveira, Monalisa F ; Dantas, Vicente C S ; Maia, Israel S ; Machado, Flávia R ; Golin, Nicole A ; Avezum, Alvaro ; Kormann, Adrian P M ; Milan, Eveline P ; Cavalcanti, Alexandre B ; Freitas, Flávio G R ; Junqueira, Debora L M ; Tramujas, Lucas

BACKGROUNDHydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.METHODSWe conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.RESULTSA total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P = 1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P = 1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.CONCLUSIONSAmong patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.).

News (Medical) associated with EMS Sigma Pharma Ltda.

17 Mar 2023

·www.prnewswire.com

EMS Sponsors the Center of Excellence in Polytrauma

EMS Partners with the Alliance for Innovation to support transport, scalable training, and delivery of rehabilitation, telehealth and PTSD services for Ukrainian trauma patients. WASHINGTON, March 17, 2023 /PRNewswire/ -- Education Management Solutions, the industry leader in healthcare education solutions, announces sponsorship of the Alliance for Innovation's Center of Excellence for Polytrauma. The Center will focus on three core humanitarian missions designed to address the most acute trauma treatment needs of soldiers in the Ukrainian conflict. First – provide prosthetics for wounded and amputee soldiers, paired with critical rehabilitation and mental health services. Second – establish the core logistics and protocols for the safe and efficient transport of patients across the Ukrainian-Polish border. Third – develop protocols and processes to facilitate the safe transport of patients back across the border, supplemented with an affordable and scalable training plan to develop clinicians and deliver telehealth services. Combined, the three mission areas will ease acute needs and accelerate the number in qualified in-country clinical professionals to provide ongoing acute trauma care. Continue Reading "Globally – we have a critical shortfall in skilled clinicians - across all disciplines," said Matt Merino, CEO of EMS. He continued, "The patient need in Ukraine is staggering. There are less 50 skilled trauma surgeons across the entire region. We are pleased to have the opportunity to contribute both support and technology to drive a solution." EMS sponsors Center of Excellence for Polytrauma to support acute combat trauma treatment for Ukraine warfighers. Tweet this The Alliance for Innovation will kick off their mission with a major fundraising event, Chopin – The Space Concert on Saturday, March 18, 2023, at the National Air and Space Museum's Steven F. Udvar-Hazy Center. The Center for Excellence in Polytrauma is a joint initiative involving multiple public and private partners including the Medical Society of Virginia, The National Center for PTSD, Department of Veterans Affairs, and Baylor College of Medicine. About EMS: Celebrating 30 years of innovation, Education Management Solutions (EMS) is a pioneer in simulation and competency-based learning for healthcare education and training. EMS provides turnkey education solutions, program management, design, installation, and 24/7 customer support for hundreds of universities, colleges, and healthcare systems worldwide. SOURCE Education Management Solutions

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