ABSTRACT
OBJECTIVE: To present the interim findings from a national study investigating the safety and efficacy of convalescent plasma (CP) containing detectable IgG antibodies as a treatment strategy for severe coronavirus disease 2019 (COVID-19). TRIAL DESIGN AND PARTICIPANTS: An open label, two-arm, phase-II clinical trial conducted across 22 hospitals from Saudi Arabia. The intervention group included 40 adults (aged ≥18 years) with confirmed severe COVID-19 and the control group included 124 patients matched using propensity score for age, gender, intubation status, and history of diabetes and/or hypertension. Intervention group included those (a) with severe symptoms (dyspnea; respiratory rate, ≥30/min; SpO2, ≤93%, PaO2/FiO2 ratio, <300; and/or lung infiltrates >50% within 24-48 h), (b) requiring intensive care unit (ICU) care or (c) experiencing life-threatening conditions. The control group included confirmed severe COVID-19 patients of similar characteristics who did not consent for CP infusion or were not able to receive CP due to its nonavailability. INTERVENTIONS: The intervention group participants were infused 300 ml (200-400 ml/treatment dose) CP at least once, and if required, daily for up to 5 sessions, along with receiving the best standard of care. The control group only received the best standard of care. OUTCOMES: The primary endpoints were safety and ICU length of stay (LOS). The secondary endpoints included 30-day mortality, days on mechanical ventilation and days to clinical recovery. RESULTS: CP transfusion did not result in any adverse effects. There was no difference in the ICU LOS (median 8 days in both groups). The mortality risk was lower in the CP group: 13% absolute risk reduction (P = 0.147), hazard ratio (95% confidence interval): 0.554 (0.299-1.027; P = 0.061) by log-rank test. There was no significant difference in the days on mechanical ventilation and days to clinical recovery. CONCLUSION: CP containing detectable antibodies is a safe strategy and may result in a decrease in mortality in patients with severe COVID-19. The results of the completed trial with a larger study sample would provide more clarity if this difference in mortality is significant. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04347681; Saudi Clinical Trials Registry No.: 20041102.
ABSTRACT
OBJECTIVES: To describe the epidemiological, clinical, and outcome data of patients infected or colonized with Chryseobacterium/Elizabethkingia spp including antibiotic susceptibility patterns. METHODS: This retrospective study was conducted at Prince Sultan Military Medical City, Riyadh, Saudi Arabia. All patients infected or colonized by Chryseobacterium /Elizabethkingia spp who were admitted between June 2013 and May 2019 were included. Data were extracted from patient electronic medical records. RESULTS: We enrolled 27 patients (13 males and 14 females) with a mean age of 35.6 years. Chryseobacterium/Elizabethkingia spp were isolated from blood cultures (n=13, 48%) and tracheal aspirations (n=11, 41%). The most frequent species isolated was Elizabethkingia meningoseptica (n=22). Although 6 patients were considered colonized, the remaining 21 patients presented with ventilator associated pneumonia (n=9), central line associated bloodstream infection (n=4), septic shock (n=4), or isolated bacteremia (n=4). In 25 cases the infections were health-care related. Three patients (11%) died within 28 days. Twenty-six isolates (96.5%) were resistant to carbapenems. Moxifloxacin and cotrimoxazole were the most active antibiotics. CONCLUSION: Chryseobacterium/Elizabethkingia spp infection is rare, but can be responsible for severe hospital acquired infections. Cotrimoxazole and fluoroquinolone are the most effective antibiotic treatments.
