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Literature Overview October 25, 2020. Many Thanks to Peter Reiss!

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Literature Overview October 25, 2020. Many Thanks to Peter Reiss! Literature Overview October 25, 2020. Many thanks to Peter Reiss! Lipsitch M, Dean N, Understanding COVID-19 efficacy. Science, October 21, 2020. https://science.sciencemag.org/content/early/2020/10/21/science.abe5938 Commentary about. COVID-19 vaccine efficacy by Marc Lipsitch and Natalie Dean Important questions that will likely remain after first vaccine trials are published and should be addressed: - First, trials are typically not powered to establish subgroup-specific efficacy, yet the performance of the vaccine in high-risk groups affects the success of a direct-protection strategy. - Second, can vaccines prevent infection or reduce contagiousness? This matters for achieving indirect protection. Treatment Toculizimab Commentary on tocilizumab studies: https://www.jwatch.org/fw117147/2020/10/20/tocilizumab-covid-19-three-studies-yield- mixed-findings?query=pfwRS&jwd=000020075418&jspc=ID Salvarani C et al, Effect of Tocilizumab vs Standard Care on Clinical Worsening in Patients Hospitalized With COVID-19 Pneumonia - A Randomized Clinical Trial. JAMA, October 21, 2020. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2772186 b Design - This is a prospective, open label RCT to evaluate the effect of early tocilizumab administration vs standard therapy in preventing clinical worsening in patients hospitalized with COVID-19 pneumonia in Italy. Eligibility criteria - included COVID-19 pneumonia documented by radiologic imaging, partial pressure of arterial oxygen to fraction of inspired oxygen (Pao2/Fio2) ratio between 200 and 300 mm Hg, and an inflammatory phenotype defined by fever and elevated C- reactive protein. Interventions - Patients in the experimental arm received 2 iv doses of tocilizumab. Patients in the control arm received supportive care following the protocols of each clinical center until clinical worsening and then could receive tocilizumab as a rescue therapy. Main Outcome and Measures - The primary composite outcome was defined as entry into the intensive care unit with invasive mechanical ventilation, death from all causes, or clinical aggravation documented by the finding of a Pao2/Fio2ratio less than 150 mm Hg, whichever came first. Results - A total of 126 patients were randomized (60 tocilizumab group; 66 control). Median age 60.0 (53.0-72.0) years, and the majority of patients were male (77 of 126, 61.1%). Three patients withdrew from the study, leaving 123 patients available for the intention-to-treat analyses. Seventeen patients of 60 (28.3%) in the tocilizumab arm and 17 of 63 (27.0%) in the standard care group showed clinical worsening within 14 days since randomization (rate ratio, 1.05; 95% CI, 0.59-1.86). Two patients in the experimental group and 1 in the control group died before 30 days from randomization, and 6 and 5 patients were intubated in the 2 groups, respectively. The trial was prematurely interrupted after an interimEffect of Tocilizumab analysis on Clinical for Worsening futility. in Patients Hospitalized With COVID-19 Pneumonia Original Investigation Research Conclusions - in this population toculizumab showed no benefit on disease progression Figure 2. Kaplan-Meier Estimates of Cumulative Clinical Worsening and Hospital Discharge A Cumulative clinical worsening B Hospital discharge rates 100 100 Standard care 80 80 Tocilizumab 60 60 40 40 Tocilizumab SStandardtandard ccareare Proportion % worsened, 20 20 Proportion discharged, % 0 0 0 2 468 10 12 14 0 5 10 15 20 25 30 Time to clinical worsening (days since randomization) Time to hospital discharge (days since randomization) No. at risk No. at risk Tocilizumab 6053 45 43 43 43 43 43 Tocilizumab 6058 39 20 11 7 4 Standard care 6356 47 46 46 46 46 46 Standard care 6360 43 18 11 7 4 Kaplan-Meier estimates of cumulative clinical worsening (A) and hospital discharge (B). ment !). All "# episodes of clinical worsening occurred within Safety Outcomes $ days after randomization (Figure !), with no differences in Serious adverse events occurred in " patients: % severe infec- time to the event between the % arms. These included "" pa- tions (standard care) and ! upper gastrointestinal tract bleeding tients who had a PaO%/FIO% ratio less than !&' mm Hg and ! pa- (experimental) that prevented the treatment administration tient who was admitted to ICU without a PaO%/FIO% ratio less (Table "). None were considered to be treatment related by site than !&' mm Hg. For %! of "" patients, the outcome was iden- investigators. There were %! (!(.!%) adverse events, !# (%"."%) tified through a double measurement of PaO%/FIO%ratio less than in the tocilizumab group and ( (!!.!%) in the standard care !&' mm Hg, with the second one performed within # hours. group. The most common adverse events were increased ala- For & patients, the second measurement was performed within nine aminotransferase level and decreased neutrophil count. the same day. For ( patients, it was not possible to perform a second assessment the same day. Discussion Secondary Outcomes Eleven patients were admitted to ICU, all within !# days since Observational studies have suggested that tocilizumab is effec- randomization, with no major differences between the % arms tive in reducing mortality and/or intubation in patients with (!'.'% vs (.)%, respectively). The rate ratio was !.%$ ()&% CI, severe COVID-!) pneumonia.!"-!( Those promising results led to '.#!-".)!) (Table %). this randomized clinical trial, which suggests that tocilizumab, Fourdeathsoccurredinthispopulation, % within !# days (! administered early in hospitalized patients with COVID-!) pneu- in the tocilizumab arm and ! in the standard care arm, !% and * monia, provides no advantage over standard supportive care. Our days since randomization) and ! between day !& and day "' (in study considered patients with mild acute respiratory distress the tocilizumab arm, !) days since randomization) (Table %). One syndrome (PaO%/FIO% ratio between %'' and "'' mm Hg) and event occurred "$ days since randomization in the tocilizumab inflammatory response characterized either by elevated CRP arm. Mortality at !# days (!.(%vs!.$%; rate ratio, !.'&; )&%CI, levels or fever with temperature greater than "* °C for % days. '.'(-!$.#)andat"' days ("."%vs!.$%; rate ratio, %.!'; )&%CI, In the ITT analysis, no significant differences were ob- '.%'-%%.$)wascomparableinthe% groups. served in the occurrence of the primary composite end point A total of !!( of !%" patients ()&.!%) were discharged from between the experimental and the control groups at !# days hospital, (' (&$.)%) within !# days and !!% ()!.!%) within "' (%*."%intheexperimentalgroupvs%(.'%inthecontrol days. Two patients were still in hospital (one in ICU) after $! group). Similar results were shown in the per-protocol analy- and $* days since randomization. The proportion of patients sis. Furthermore, no difference between the study groups was discharged within !# and "' days (Table %)wasthesameinthe observed for any of the " outcomes composing the primary end % groups (rate ratio, '.)); )&% CI, '.("-!."&; and '.)*; )&% CI, point, including the proportion of patients admitted to an ICU '.*(-!.'); respectively). No difference in PaO%/FIO% ratio and or the overall mortality. These findings were also similar at "' lymphocyte count was observed in the % groups at !# days days from randomization. (eFigure in Supplement !). Notably, our study has a low lethality, with ! ('.*%) de- ceased patient at !# days and % more (%.#% overall) at "' days Per-Protocol Analysis of follow-up in the !%" patients included in the ITT popula- Results are detailed in eTable % in Supplement !. In the popu- tion. This can have several and possibly concurring explana- lation of !!" patients, the results confirmed those observed in tions. First, we excluded patients not eligible for a future ad- the ITT analyses. mission to the ICU regardless of the evolution of the clinical jamainternalmedicine.com (Reprinted) JAMA Internal Medicine Published online October 20, 2020 E5 © 2020 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ by Vanessa Harris on 10/27/2020 Stone J et al, Efficacy of Tocilizumab in Patients Hospitalized with Covid-19, NEJM, October 21, 2020. https://www.nejm.org/doi/full/10.1056/NEJMoa2028836 Randomized, double-blind, placebo-controlled trial involving patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation greater than 92%. Patients were randomly assigned in a 2:1 ratio to receive standard care plus a single dose of either tocilizumab (8 mg per kilogram of body weight) or placebo. The primary outcome was intubation or death, assessed in a time-to-event analysis. The secondary efficacy outcomes were clinical worsening and discontinuation of supplemental oxygen among patients who had been receiving it at baseline, both assessed in time-to- event analyses. Results - 243 patients; 141 (58%) were men. Median age was 59.8 years (range, 21.7 to 85.4), and 45% of the patients were Hispanic or Latino. Hazard ratio for intubation or death in the tocilizumab group as compared with the placebo group was 0.83 (95% confidence interval [CI], 0.38 to 1.81; P=0.64), and the hazard ratio for disease worsening was 1.11 (95% CI, 0.59 to 2.10; P=0.73). At 14 days, 18.0% of the patients in the tocilizumab group and
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