Background We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19. Methods In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov , NCT04501978 . Findings Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50–72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74–1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67–1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74–1·58]; BRII-196 plus BRII-198 1·00 [0·68–1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91–...

Rapid automatized naming (RAN) has been shown to be a strong correlate of reading abilities. RAN also predicts future reading across different ages, ability levels, and languages, and is often used in literacy screening. Thus, understanding the specific relations between early RAN and later reading difficulties is important, particularly for screening. This systematic review and meta‐analysis (with N = 60 samples; k = 373 effect sizes; n = 10,513 participants), was the first to test the extent to which measures of RAN assessed before grade school predict future reading performance in English‐speaking children. We also tested whether characteristics of the RAN tasks, reading measures, or sample demographics moderate this relationship. We found that overall, kindergarten/preschool RAN is correlated with grade‐school reading at r = −.38, similar in magnitude to previous concurrent meta‐analyses that included various ages and languages. We found that alphanumeric RAN tasks were more strongly related to future reading than were non‐alphanumeric tasks, as well as that RAN significantly predicts all types of reading measures tested, but more strongly predicts real word than nonword reading. To assess the role of RAN’s unique predictive power, we also meta‐analyzed the semipartial correlations of early RAN with later reading when controlling for phonological awareness (PA); the result of rsp = −.25 demonstrates RAN’s significant, unique contribution beyond PA. These results support shared cognitive resource models in which the similarity between RAN and reading tasks accounts for their correlation. We provide practical guidelines for based on these data for early screening for reading difficulties and dyslexia.

Rapid automatized naming (RAN) tasks have been shown to be a strong correlate of reading abilities. RAN also predicts future reading across different ages, ability levels, and languages, and is often used in literacy screening. Thus, understanding the specific relations between early RAN and later reading difficulties is important. In this systematic review and meta-analysis (with N = 68 samples; k = 373 effect sizes; n = 10,513 participants), we test the extent to which measures of RAN assessed before grade school predict later reading performance in English-speaking children. We also test whether characteristics of the RAN tasks, reading measures, or sample demographics moderate this relationship. We found that kindergarten/preschool RAN is correlated with grade-school reading at r = -.38, similar in magnitude to previous meta-analyses that included various ages and languages. We found that alphanumeric RAN tasks are particularly strongly related to future reading, as compared with non-alphanumeric tasks (p = .01) but that other features of the RAN task, such as the number of items, do not alter its predictive significance. RAN predicts all types of reading measures, but more strongly predicts real word than nonword reading (p < .001). These results support a shared cognitive resource model in which the similarity between RAN and reading tasks accounts for their correlation. We provide practical guidelines based on these data for early screening for reading difficulties and dyslexia.

Objectives: Vaping-associated lung injury has rapidly become a nationwide epidemic and a threat to public health. In this case series, we describe unique clinical features of severe vaping-associated lung injury, defined as respiratory failure due to vaping that requires mechanical ventilation. Data Sources: Clinical observation of four patients. Study Selection: Case series. Data Extraction: Data and images were extract from medical records after approval was obtained from the institutional review board. Data Synthesis: Four patients were admitted to the ICU with severe manifestation of vaping-associated lung injury. Although every case required mechanical ventilatory support (venovenous extracorporeal membrane oxygenation in one patient), all patients survived and were discharged without supplemental oxygen. Systemic corticosteroids were administered in three patients and N-acetyl cysteine in one. A postdischarge pulmonary function test in one patient was normal except for mildly decreased diffusing capacity. Conclusions: Based on our experience, prognosis of severe vaping-associated lung injury appears favorable with aggressive supportive care, although there is evidence from existing literature that mortality rate might rise with increasing disease severity. Underlying mechanism of lung injury might be similar between vaping-associated lung injury and amiodarone pneumonitis. Foamy or lipid-laden macrophages, seen in both conditions, might be a marker of cytotoxicity from substances contained in e-cigarettes, such as vitamin E acetate. Systemic corticosteroids, and possibly N-acetyl cysteine, could be considered as therapeutic adjuncts in vaping-associated lung injury. Serial pulmonary function tests should be obtained in these patients to monitor for potential long-term complications. The primary limitations of this case series are its small sample and lack of longitudinal follow-up data.

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