Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Background: In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Findings: Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12–1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77–0·92; p<0·0001). Interpretation: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings: Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93–1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94–1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93–1·05; p=0·79). Interpretation: In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

Escolarização inclusiva de alunos com autismo na rede municipal de ensino de Belo Horizonte Inclusive schooling of students with autism in municipal education of Belo Horizonte

O direito a matrícula de alunos com necessidades educacionais especiais em escolas regulares no Brasil é garantido por lei desde a Constituição de 1988. Os dados do Censo Escolar do Ministério da Educação indicam aumento no número de matrícula desses alunos no país ao longo dos anos, especialmente em escolas da rede municipal de ensino. Entre os alunos enquadrados na definição de "necessidades especiais" encontram-se aqueles com autismo, caracterizados por apresentarem alterações na interação social, na comunicação e pela presença de padrões estereotipados de comportamento. A prefeitura de Belo Horizonte - MG vem desenvolvendo ações com o intuito de favorecer o acesso de estudantes com autismo a escolas regulares do município, porém dados sobre o andamento deste processo são escassos. O objetivo desse estudo consistiu em caracterizar os alunos com autismo matriculados em escolas municipais regulares de Belo Horizonte, assim como descrever a maneira pela qual essa escolarização vem ocorrendo nas escolas comuns, a partir da perspectiva de seus professores. Participaram do estudo trinta e três professores da rede regular de ensino do município que tinham contato direto e diário com alunos com autismo. Foram utilizados um questionário semi-estruturado e a escala CARS (Childhood Autism Rating Scale). Os resultados indicaram que as estratégias utilizadas pela prefeitura parecem favorecer a freqüência dos alunos com autismo, porém há evidências de que eles participam pouco das atividades da escola, a interação com os colegas é escassa e a aprendizagem de conteúdos pedagógicos é limitada.<br>The right to enroll students with special needs in regular schools in Brazil is guaranteed by law since the 1988 Constitution. Ministry of Education school census data indicates that the number of students with special needs enrolled in regular schools in the country has increased over the years, especially in the municipal system of education. Among the students regarded as having "special needs" are those with autism, who show impairment in social interaction, communication and stereotypical behavior patterns. The city of Belo Horizonte - MG has been taking action in order to improve access for students with autism in regular schools in the city, but data of the progress of this process is scarce. The purpose of this research was to characterize the students with autism enrolled in regular public schools in Belo Horizonte, as well as describe the way in which this schooling is occurring in regular schools, from the perspective of the teachers. Thirty-three teachers who had direct and daily contact with students with autism in regular schools in the city participated in this research. A semi-structured questionnaire and the Childhood Autism Rating Scale (CARS) were used. The results indicated that the strategies used by the city seem to enable the presence of the students with autism in the schools, but there is evidence that their participation in school activities is restricted, the interactions with their peers is scarce, and the content learned from the school curriculum is limited