1.
Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial.
Miller, J, Bruen, C, Schnaus, M, Zhang, J, Ali, S, Lind, A, Stoecker, Z, Stauderman, K, Hebbar, S
Critical care (London, England). 2020;(1):502
Abstract
BACKGROUND Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications observed in patients with COVID-19. This study aimed to investigate the safety and efficacy of Auxora, a novel, intravenously administered CRAC channel inhibitor, in adults with severe or critical COVID-19 pneumonia. METHODS A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess the safety and tolerability of Auxora. Following FDA guidance, study enrollment was halted early to allow for transition to a randomized, blinded, placebo-controlled study. RESULTS In total, 17 patients with severe and three with critical COVID-19 pneumonia were randomized to Auxora and nine with severe and one with critical COVID-19 pneumonia to SOC. Similar proportions of patients receiving Auxora and SOC experienced ≥ 1 adverse event (75% versus 80%, respectively). Fewer patients receiving Auxora experienced serious adverse events versus SOC (30% versus 50%, respectively). Two patients (10%) receiving Auxora and two (20%) receiving SOC died during the 30 days after randomization. Among patients with severe COVID-19 pneumonia, the median time to recovery with Auxora was 5 days versus 12 days with SOC; the recovery rate ratio was 1.87 (95% CI, 0.72, 4.89). Invasive mechanical ventilation was needed in 18% of patients with severe COVID-19 pneumonia receiving Auxora versus 50% receiving SOC (absolute risk reduction = 32%; 95% CI, - 0.07, 0.71). Outcomes measured by an 8-point ordinal scale were significantly improved for patients receiving Auxora, especially for patients with a baseline PaO2/FiO2 = 101-200. CONCLUSIONS Auxora demonstrated a favorable safety profile in patients with severe or critical COVID-19 pneumonia and improved outcomes in patients with severe COVID-19 pneumonia. These results, however, are limited by the open-label study design and small patient population resulting from the early cessation of enrollment in response to regulatory guidance. The impact of Auxora on respiratory complications in patients with severe COVID-19 pneumonia will be further assessed in a planned randomized, blinded, placebo-controlled study. TRIAL REGISTRATION ClinicalTrials.gov, NCT04345614 . Submitted on 7 April 2020.
2.
Herbal medicine for treatment of children diagnosed with COVID-19: A review of guidelines.
Ang, L, Lee, HW, Kim, A, Lee, JA, Zhang, J, Lee, MS
Complementary therapies in clinical practice. 2020;:101174
Abstract
This review aimed to summarize and analyze the pattern identification (PI), herbal formulae, and composition of herbs provided by recent guidelines for the treatment of pediatric COVID-19. Seven data sources were reviewed until March 25, 2020. We analyzed the herbal formulae included in the guidelines and performed a network analysis to identify the frequency of herbs recommended in the herbal formulae. All 3 guidelines were provincial guidelines from China. Our results showed that there were 4 stages, 12 PIs, and 13 herbal formulae recommended by the provincial guidelines. These herbal formulae included a total of 56 herbs. Based on our network analysis, Scutellariae Radix was paired with Artemisiae Annuae Herba in one cluster. In another cluster, Armeniacae Semen was paired with Coicis Semen and Ephedrae Herba was paired with Gypsum Fibrosum. This review serves as a reference for the use of traditional medicine in the treatment of pediatric COVID-19.
3.
Association between regional selenium status and reported outcome of COVID-19 cases in China.
Zhang, J, Taylor, EW, Bennett, K, Saad, R, Rayman, MP
The American journal of clinical nutrition. 2020;(6):1297-1299