Browsing by Author "Zarychanski, Ryan"
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- ItemOpen AccessConvalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial(2021-05-04) Bégin, Philippe; Callum, Jeannie; Heddle, Nancy M; Cook, Richard; Zeller, Michelle P; Tinmouth, Alan; Fergusson, Dean A; Cushing, Melissa M; Glesby, Marshall J; Chassé, Michaël; Devine, Dana V; Robitalle, Nancy; Bazin, Renée; Shehata, Nadine; Finzi, Andrés; McGeer, Allison; Scales, Damon C; Schwartz, Lisa; Turgeon, Alexis F; Zarychanski, Ryan; Daneman, Nick; Carl, Richard; Amorim, Luiz; Gabe, Caroline; Ellis, Martin; Sachais, Bruce S; Loftsgard, Kent C; Jamula, Erin; Carruthers, Julie; Duncan, Joanne; Lucier, Kayla; Li, Na; Liu, Yang; Armali, Chantal; Kron, Amie; Modi, Dimpy; Auclair, Marie-Christine; Cerro, Sabrina; Avram, Meda; Arnold, Donald MAbstract Background Convalescent plasma has been used for numerous viral diseases including influenza, severe acute respiratory syndrome, Middle East respiratory syndrome and Ebola virus; however, evidence to support its use is weak. SARS-CoV-2 is a novel coronavirus responsible for the 2019 global pandemic of COVID-19 community acquired pneumonia. We have undertaken a randomized controlled trial to assess the efficacy and safety of COVID-19 convalescent plasma (CCP) in patients with SARS-CoV-2 infection. Methods CONCOR-1 is an open-label, multicentre, randomized trial. Inclusion criteria include the following: patients > 16 years, admitted to hospital with COVID-19 infection, receiving supplemental oxygen for respiratory complications of COVID-19, and availability of blood group compatible CCP. Exclusion criteria are : onset of respiratory symptoms more than 12 days prior to randomization, intubated or imminent plan for intubation, and previous severe reactions to plasma. Consenting patients are randomized 2:1 to receive either approximately 500 mL of CCP or standard of care. CCP is collected from donors who have recovered from COVID-19 and who have detectable anti-SARS-CoV-2 antibodies quantified serologically. The primary outcome is intubation or death at day 30. Secondary outcomes include ventilator-free days, length of stay in intensive care or hospital, transfusion reactions, serious adverse events, and reduction in SARS-CoV-2 viral load. Exploratory analyses include patients who received CCP containing high titre antibodies. A sample size of 1200 patients gives 80% power to detect a 25% relative risk reduction assuming a 30% baseline risk of intubation or death at 30 days (two-sided test; α = 0.05). An interim analysis and sample size re-estimation will be done by an unblinded independent biostatistician after primary outcome data are available for 50% of the target recruitment (n = 600). Discussion This trial will determine whether CCP will reduce intubation or death non-intubated adults with COVID-19. The trial will also provide information on the role of and thresholds for SARS-CoV-2 antibody titres and neutralization assays for donor qualification. Trial registration Clinicaltrials.gov NCT04348656 . Registered on 16 April 2020.
- ItemOpen AccessNational Preclinical Sepsis Platform: developing a framework for accelerating innovation in Canadian sepsis research(2021-03-19) Mendelson, Asher A; Lansdell, Casey; Fox-Robichaud, Alison E; Liaw, Patricia; Arora, Jaskirat; Cailhier, Jean-François; Cepinskas, Gediminas; Charbonney, Emmanuel; dos Santos, Claudia; Dwivedi, Dhruva; Ellis, Christopher G; Fergusson, Dean; Fiest, Kirsten; Gill, Sean E; Hendrick, Kathryn; Hunniford, Victoria T; Kowalewska, Paulina M; Krewulak, Karla; Lehmann, Christian; Macala, Kimberly; Marshall, John C; Mawdsley, Laura; McDonald, Braedon; McDonald, Ellen; Medeiros, Sarah K; Muniz, Valdirene S; Osuchowski, Marcin; Presseau, Justin; Sharma, Neha; Sohrabipour, Sahar; Sunohara-Neilson, Janet; Vázquez-Grande, Gloria; Veldhuizen, Ruud A W; Welsh, Donald; Winston, Brent W; Zarychanski, Ryan; Zhang, Haibo; Zhou, Juan; Lalu, Manoj MAbstract Despite decades of preclinical research, no experimentally derived therapies for sepsis have been successfully adopted into routine clinical practice. Factors that contribute to this crisis of translation include poor representation by preclinical models of the complex human condition of sepsis, bias in preclinical studies, as well as limitations of single-laboratory methodology. To overcome some of these shortcomings, multicentre preclinical studies—defined as a research experiment conducted in two or more research laboratories with a common protocol and analysis—are expected to maximize transparency, improve reproducibility, and enhance generalizability. The ultimate objective is to increase the efficiency and efficacy of bench-to-bedside translation for preclinical sepsis research and improve outcomes for patients with life-threatening infection. To this end, we organized the first meeting of the National Preclinical Sepsis Platform (NPSP). This multicentre preclinical research collaboration of Canadian sepsis researchers and stakeholders was established to study the pathophysiology of sepsis and accelerate movement of promising therapeutics into early phase clinical trials. Integrated knowledge translation and shared decision-making were emphasized to ensure the goals of the platform align with clinical researchers and patient partners. 29 participants from 10 independent labs attended and discussed four main topics: (1) objectives of the platform; (2) animal models of sepsis; (3) multicentre methodology and (4) outcomes for evaluation. A PIRO model (predisposition, insult, response, organ dysfunction) for experimental design was proposed to strengthen linkages with interdisciplinary researchers and key stakeholders. This platform represents an important resource for maximizing translational impact of preclinical sepsis research.
- ItemOpen AccessSystematic Review and Meta-analysis of Interventions for Depression and Anxiety in Persons With Rheumatoid Arthritis(LIPPINCOTT WILLIAMS & WILKINS, 2017) Fiest, Kirsten M.; Hitchon, Carol A.; Bernstein, Charles N.; Peschken, Christine A.; Walker, John R.; Graff, Lesley A.; Zarychanski, Ryan; Abou-Setta, Ahmed; Patten, Scott B.; Sareen, Jitender; Bolton, James; Marrie, Ruth AnnBackground Psychiatric comorbidities, such as depression and anxiety, are very common in persons with rheumatoid arthritis (RA) and can lead to adverse outcomes. By appropriately treating these comorbidities, disease-specific outcomes and quality of life may be improved. Objective The aim of this study was to systematically review the literature from controlled trials of treatments for depression and anxiety in persons with RA. Methods We searched multiple online databases from inception until March 25, 2015, without restrictions on language, date, or location of publication. We included controlled trials conducted in persons with RA and depression or anxiety. Two independent reviewers extracted information including trial and participant characteristics. The standardized mean differences (SMDs) of depression or anxiety scores at postassessment were pooled between treatment and comparison groups, stratified by active versus inactive comparators. Results From 1291 unique abstracts, we included 8 RA trials of depression interventions (6 pharmacological, 1 psychological, 1 both). Pharmacological interventions for depression with inactive comparators (n = 3 trials, 143 participants) did not reduce depressive symptoms (SMD, -0.21; 95% confidence interval [CI], -1.27 to 0.85), although interventions with active comparators (n = 3 trials, 190 participants) did improve depressive symptoms (SMD, -0.79; 95% CI, -1.34 to -0.25). The single psychological trial of depression treatment in RA did not improve depressive symptoms (SMD, -0.44; 95% CI, -0.96 to 0.08). Seven of the trials had an unclear risk of bias. Conclusions Few trials examining interventions for depression or anxiety in adults with RA exist, and the level of evidence is low to moderate because of the risk of bias and small number of trials.
- ItemOpen AccessSystematic review of interventions for depression and anxiety in persons with inflammatory bowel disease(BMC, 2016) Fiest, Kirsten M.; Bernstein, Charles N.; Walker, John R.; Graff, Lesley A.; Hitchon, Carol A.; Peschken, Christine A.; Zarychanski, Ryan; Abou-Setta, Ahmed; Patten, Scott B.; Sareen, Jitender; Bolton, James; Singer, Alexander; Marrie, Ruth AnnBackground Depression and anxiety are common in inflammatory bowel disease (IBD) and can affect disease outcomes, including quality of life and success of disease treatment. Successful management of psychiatric comorbidities may improve outcomes, though the effectiveness of existing treatments in IBD is unknown. Methods We searched multiple online databases from inception until March 25, 2015, without restrictions on language, date, or location of publication. We included controlled clinical trials conducted in persons with IBD and depression or anxiety. Two independent reviewers reviewed all abstracts and full-text articles and extracted information including trial and participant characteristics. We also assessed the risk of bias. Results Of 768 unique abstracts, we included one trial of pharmacological anxiety treatment in IBD (48 participants), which found an improvement in anxiety symptoms (p < 0.001). There was a high risk of bias in this trial. We found no controlled clinical trials on the treatment of depression in persons with IBD and depression and no controlled clinical trials reporting on psychological interventions for anxiety or depression in IBD. Conclusions Only one trial examined an intervention for anxiety in adults with IBD and no trials studied depression in adults with IBD. The level of evidence is low because of the risk of bias and limited evidence.