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Background: The efficacy and safety of prophylactic full-dose anticoagulation and antiplatelet therapy in critically ill COVID-19 patients remain uncertain. Methods: COVID-PACT (Prevention of Arteriovenous Thrombotic Events in Critically-ill COVID-19 Patients Trial) was a multicenter, 2×2 factorial, open-label, randomized-controlled trial with blinded end point adjudication in intensive care unit–level patients with COVID-19. Patients were randomly assigned to a strategy of full-dose anticoagulation or standard-dose prophylactic anticoagulation. Absent an indication for antiplatelet therapy, patients were additionally randomly assigned to either clopidogrel or no antiplatelet therapy. The primary efficacy outcome was the hierarchical composite of death attributable to venous or arterial thrombosis, pulmonary embolism, clinically evident deep venous thrombosis, type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute limb ischemia, or clinically silent deep venous thrombosis, through hospital discharge or 28 days. The primary efficacy analyses included an unmatched win ratio and time-to-first event analysis while patients were on treatment. The primary safety outcome was fatal or life-threatening bleeding. The secondary safety outcome was moderate to severe bleeding. Recruitment was stopped early in March 2022 (≈50% planned recruitment) because of waning intensive care unit–level COVID-19 rates. Results: At 34 centers in the United States, 390 patients were randomly assigned between anticoagulation strategies and 292 between antiplatelet strategies (382 and 290 in the on-treatment analyses). At randomization, 99% of patients required advanced respiratory therapy, including 15% requiring invasive mechanical ventilation; 40% required invasive ventilation during hospitalization. Comparing anticoagulation strategies, a greater proportion of wins occurred with full-dose anticoagulation (12.3%) versus standard-dose prophylactic anticoagulation (6.4%; win ratio, 1.95 [95% CI, 1.08–3.55]; P =0.028). Results were consistent in time-to-event analysis for the primary efficacy end point (full-dose versus standard-dose incidence 19/191 [9.9%] versus 29/191 [15.2%]; hazard ratio, 0.56 [95% CI, 0.32–0.99]; P =0.046). The primary safety end point occurred in 4 (2.1%) on full dose and in 1 (0.5%) on standard dose ( P =0.19); the secondary safety end point occurred in 15 (7.9%) versus 1 (0.5%; P =0.002). There was no difference in all-cause mortality (hazard ratio, 0.91 [95% CI, 0.56–1.48]; P =0.70). There were no differences in the primary efficacy or safety end points with clopidogrel versus no antiplatelet therapy. Conclusions: In critically ill patients with COVID-19, full-dose anticoagulation, but not clopidogrel, reduced thrombotic complications with an increase in bleeding, driven primarily by transfusions in hemodynamically stable patients, and no apparent excess in mortality. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04409834.

SESSION TITLE: Fellows Pulmonary Manifestations of Systemic Disease Posters SESSION TYPE: Fellow Case Report Posters PRESENTED ON: October 18-21, 2020 INTRODUCTION: Infection and trauma are the most common causes of acute respiratory distress syndrome (ARDS) However, ARDS has a lengthy differential diagnosis and rare etiologies must be considered when more common causes are excluded or with atypical clinical presentations CASE PRESENTATION: A healthy 18 y/o male presented to the hospital with a five day history of cough, hemoptysis and fever In the ER he was found to have hypoxic respiratory failure He was placed on the regular medical floor on supplemental oxygen via nasal canula Initial chest x-ray showed bilateral upper lobe interstitial infiltrates In the emergency room he was tested for COVID-19 and other common respiratory viruses His COVID-19 was negative but his screen came back positive for adenovirus Through the first day of his admission his oxygen requirements continued to increase He was intubated and diagnosed with severe acute respiratory distress syndrome (ARDS) He was started on broad spectrum antibiotics Despite ARDSnet protocol and supportive care his oxygenation did not improve His ferritin levels increased to greater than 20,000 ng/dl and his d-dimer nadired at 17 2 mg/L Because of these abnormalities and three total negative COVID-19 tests, a hematology consult was placed Hematology diagnosed patient with secondary HLH from adenovirus He was started on etoposide and dexamethasone per HLH-94 guidelines His oxygenation worsened and he was placed on veno-venous extra-corporeal membrane oxygenation (ECMO) Despite antivirals, chemotherapy and ECMO the patient ultimately succumbed to his illness on day 20 of his admission DISCUSSION: Inherited and acquired HLH is a common known disease process in children, even though it is rarely seen In adults HLH is often sought but seldom actually found Adenovirus induced HLH is a rare disease in children, and unheard of in adults Treatment of HLH is based off of the HLH-94 protocol, developed in 1995 by the Hemophagocytic Lymphohistiocytosis Study Group New recommendations were made in 2004 The intent of these guidelines was to add newer immunotherapy with well established chemotherapeutic regiments To date no clear guidelines for the treatment of HLH in adults has been set forth, therefore the pediatric treatment guidelines are often used for adult treatment as well Novel treatment approaches have been reported for HLH induced by Epstein Barr Virus in adults, but none exist for adenovirus induced HLH ARDS is not a common manifestation of HLH The diagnosis is difficult to make because of poor recognition, therefore its prevalence in adults is uncertain Unfortunately, as in this case, the disease is almost universally fatal With the current healthcare environment being inundated with COVID-19, careful consideration and investigation was needed to arrive at the correct diagnosis CONCLUSIONS: ARDS is an uncommon presentation of an uncommon disease, secondary HLH Reference #1: Hayden A, Park S, Giustini D, Lee AY, Chen LY Hemophagocytic syndromes (HPSs) including hemophagocytic lymphohistiocytosis (HLH) in adults: a systematic scoping review Blood Rev (2016) 30:411–20 doi:10 1016/j blre 2016 05 001 Reference #2: Trottestam H, Horne A, Arico M, et al Histiocyte SocietyChemoimmunotherapy for hemophagocytic lymphohistiocytosis: long-term results of the HLH-94 treatment protocol , Blood, 2011, vol 118 17(pg 4577-4584) DISCLOSURES: No relevant relationships by Anna Plemmons, source=Web Response No relevant relationships by William Pruett, source=Web Response No relevant relationships by Michael Sanley, source=Web Response

Background Bedside percutaneous tracheostomy (PT) placement in critically ill patients is performed in a variety of ways, largely driven by institutional preference. We have recently transitioned to primarily extubating the patient and placing a laryngeal mask airway (LMA) before tracheostomy insertion in lieu of retracting the endotracheal tube (ETT) in place. This allows for lower sedative use and provides a superior view of the operative field. Here, we seek to describe the safety and efficiency of that approach. Methods This is a single-center cross-sectional study from 2014 to 2016 comparing patients who underwent PT with the ETT in place retracted to the proximal larynx versus those who were extubated and had a LMA placed. Procedural length, sedative totals, and safety outcomes were recorded. Results In total, 125 patients underwent PT during the study period, 75 via a LMA and 50 via existing ETT. There was no difference in procedural duration (LMA: 53.5±21.4 min vs. ETT: 50.4±16.8; P=0.41), total complications (LMA: 29.3% vs. 16%; P=0.09) or major complications (4% in both groups). Cisatracurium use was significantly lower in the LMA arm (LMA: 1.0±3.6 mg vs. ETT: 11.5±5.9 mg; P Conclusion Replacing the ETT with an LMA before PT is equally safe, does not increase total procedural duration, and all but eliminates the need for paralytic agents.