Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.

BACKGROUND: The role of remdesivir in the treatment of patients in hospital with COVID-19 remains ill defined in a global context. The World Health Organization Solidarity randomized controlled trial (RCT) evaluated remdesivir in patients across many countries, with Canada enrolling patients using an expanded data collection format in the Canadian Treatments for COVID-19 (CATCO) trial. We report on the Canadian findings, with additional demographics, characteristics and clinical outcomes, to explore the potential for differential effects across different health care systems. METHODS: We performed an open-label, pragmatic RCT in Canadian hospitals, in conjunction with the Solidarity trial. We randomized patients to 10 days of remdesivir (200 mg intravenously [IV] on day 0, followed by 100 mg IV daily), plus standard care, or standard care alone. The primary outcome was in-hospital mortality. Secondary outcomes included changes in clinical severity, oxygen- and ventilator-free days (at 28 d), incidence of new oxygen or mechanical ventilation use, duration of hospital stay, and adverse event rates. We performed a priori subgroup analyses according to duration of symptoms before enrolment, age, sex and severity of symptoms on presentation. RESULTS: Across 52 Canadian hospitals, we randomized 1282 patients between Aug. 14, 2020, and Apr. 1, 2021, to remdesivir (n = 634) or standard of care (n = 648). Of these, 15 withdrew consent or were still in hospital, for a total sample of 1267 patients. Among patients assigned to receive remdesivir, in-hospital mortality was 18.7%, compared with 22.6% in the standard-of-care arm (relative risk [RR] 0.83 (95% confidence interval [CI] 0.67 to 1.03), and 60-day mortality was 24.8% and 28.2%, respectively (95% CI 0.72 to 1.07). For patients not mechanically ventilated at baseline, the need for mechanical ventilation was 8.0% in those assigned remdesivir, and 15.0% in those receiving standard of care (RR 0.53, 95% CI 0.38 to 0.75). Mean oxygen-free and ventilator-free days at day 28 were 15.9 (± standard deviation [SD] 10.5) and 21.4 (± SD 11.3) in those receiving remdesivir and 14.2 (± SD 11) and 19.5 (± SD 12.3) in those receiving standard of care (p = 0.006 and 0.007, respectively). There was no difference in safety events of new dialysis, change in creatinine, or new hepatic dysfunction between the 2 groups. INTERPRETATION: Remdesivir, when compared with standard of care, has a modest but significant effect on outcomes important to patients and health systems, such as the need for mechanical ventilation. Trial registration: ClinicalTrials.gov, no. NCT04330690.

Ultrasonographic and histopathological features of cervical lymph node metastases.

OBJECTIVES: Different approaches have been made to differentiate benignant from malignant cervical lymphadenopathy using ultrasound examination. Assessment of nodal status is essential in patients with head and neck carcinomas as it predicts prognosis and helps in the selection of treatment options. The present study was designed to evaluate the role of ultrasound in the assessment of malignant cervical lymph nodes using the histological gold standard results. Gray-scale ultrasound assesses the nodal size, shape, border, internal architecture and color Doppler ultrasound evaluate the vascular pattern of lymph nodes. MATERIALS AND METHODS: 158 cervical lymphadenopathies evaluated by ultrasound in 100 patients over a period of 36 months (between January 2010 and December 2012) were evaluated for the presence of intranodal vascular pattern, which was considered benignant when it traversed through the node without disruption. RESULTS: Of the 158 cervical tumors evaluated, 114 (72.2%) were found to be malignant on pathologic review. Malignant vascular markings were present in 133/158 lymph nodes evaluated. The presence of malignant vascular pattern had a sensitivity of 97.37% and a positive predictive value of 82.84%. Malignant gray-scale ultrasound markings had a sensitivity of 23.3% and a positive predictive value of 100%. CONCLUSIONS: The presence of normal intranodal blood flow was associated with a benignant diagnosis in 87.5% of the masses evaluated. The addition of this color Doppler ultrasound finding improves the ability of ultrasound exam to predict the likelihood of malignant involvement.