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Background The efficacy of ivermectin in preventing hospitalization or extended observation in an emergency setting among outpatients with acutely symptomatic coronavirus disease 2019 (Covid-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is unclear. Methods We conducted a double-blind, randomized, placebo-controlled, adaptive platform trial involving symptomatic SARS-CoV-2–positive adults recruited from 12 public health clinics in Brazil. Patients who had had symptoms of Covid-19 for up to 7 days and had at least one risk factor for disease progression were randomly assigned to receive ivermectin (400 μg per kilogram of body weight) once daily for 3 days or placebo. (The trial also involved other interventions that are not reported here.) The primary composite outcome was hospitalization due to Covid-19 within 28 days after randomization or an emergency department visit due to clinical worsening of Covid-19 (defined as the participant remaining under observation for >6 hours) within 28 days after randomization. Results A total of 3515 patients were randomly assigned to receive ivermectin (679 patients), placebo (679), or another intervention (2157). Overall, 100 patients (14.7%) in the ivermectin group had a primary-outcome event, as compared with 111 (16.3%) in the placebo group (relative risk, 0.90; 95% Bayesian credible interval, 0.70 to 1.16). Of the 211 primary-outcome events, 171 (81.0%) were hospital admissions. Findings were similar to the primary analysis in a modified intention-to-treat analysis that included only patients who received at least one dose of ivermectin or placebo (relative risk, 0.89; 95% Bayesian credible interval, 0.69 to 1.15) and in a per-protocol analysis that included only patients who reported 100% adherence to the assigned regimen (relative risk, 0.94; 95% Bayesian credible interval, 0.67 to 1.35). There were no significant effects of ivermectin use on secondary outcomes or adverse events. Conclusions Treatment with ivermectin did not result in a lower incidence of medical admission to a hospital due to progression of Covid-19 or of prolonged emergency department observation among outpatients with an early diagnosis of Covid-19. (Funded by FastGrants and the Rainwater Charitable Foundation; TOGETHER ClinicalTrials.gov number, NCT04727424 .)

IMPORTANCEData on the efficacy of hydroxychloroquine or lopinavir-ritonavir for the treatment of high-risk outpatients with COVID-19 in developing countries are needed. OBJECTIVE To determine whether hydroxychloroquine or lopinavir-ritonavir reduces hospitalization among high-risk patients with early symptomatic COVID-19 in an outpatient setting. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial was conducted in Brazil.Recently symptomatic adults diagnosed with respiratory symptoms from SARS-CoV-2 infection were enrolled between June 2 and September 30, 2020. The planned sample size was 1476 patients, with interim analyses planned after 500 patients were enrolled. The trial was stopped after the interim analysis for futility with a sample size of 685 patients. Statistical analysis was performed in December 2020.INTERVENTIONS Patients were randomly assigned to hydroxychloroquine (800 mg loading dose, then 400 mg daily for 9 days), lopinavir-ritonavir (loading dose of 800 mg and 200 mg, respectively, every 12 hours followed by 400 mg and 100 mg, respectively, every 12 hours for the next 9 days), or placebo. MAIN OUTCOMES AND MEASURESThe primary outcomes were COVID-19-associated hospitalization and death assessed at 90 days after randomization. COVID-19-associated hospitalization was analyzed with a Cox proportional hazards model. The trial included the following secondary outcomes: all-cause hospitalization, viral clearance, symptom resolution, and adverse events. RESULTSOf 685 participants, 632 (92.3%) self-identified as mixed-race, 377 (55.0%) were women, and the median (range) age was 53 (18-94) years. A total of 214 participants were randomized to hydroxychloroquine; 244, lopinavir-ritonavir; and 227, placebo. At first interim analysis, the data safety monitoring board recommended stopping enrollment of both hydroxychloroquine and lopinavir-ritonavir groups because of futility. The proportion of patients hospitalized for COVID-19 was 3.7% (8 participants) in the hydroxychloroquine group, 5.7% (14 participants) in the lopinavirritonavir group, and 4.8% (11 participants) in the placebo group. We found no significant differences between interventions for COVID-19-associated hospitalization (hydroxychloroquine: hazard ratio [HR], 0.76 [95% CI, 0.30-1.88]; lopinavir-ritonavir: HR, 1.16 [95% CI, 0.53-2.56] as well as for the secondary outcome of viral clearance through day 14 (hydroxychloroquine: odds ratio [OR], 0.91 (continued)

A introdução do Programa Saúde da Família foi uma tentativa de reorganizar a atenção básica no país, que instituiu a Visita Domiciliar, como instrumento diferencial da atuação do Médico de Família. Para estabelecer prioridades na visita, elaborou-se escala de risco familiar baseada na ficha A do SIAB. Tal escala se baseia em sentinelas de risco que são avaliadas na primeira visita domiciliar pelo agente de saúde (ACS). A mesma foi aplicada em diferentes comunidades e microáreas, demonstrando diversas proporções de famílias classificadas como risco 1, 2 ou 3. Os resultados ressaltam a relação morador/cômodo como um importante indicador na avaliação do risco, bem como a aplicabilidade da escala como instrumento de priorização tanto das visitas domiciliares quanto do investimento da equipe. A escala demonstrou ser um instrumento simples e eficiente de análise do risco familiar, não necessitando a criação de nenhuma nova ficha ou escala burocrática. Os autores sugerem que somente o uso sistemático da Escala de Coelho como instrumento de reorganização da demanda, e posterior avaliação de seu impacto na comunidade, poderá confirmar sua aplicabilidade na atuação do médico de família.

Background The efficacy of a single dose of pegylated interferon lambda in preventing clinical events among outpatients with acute symptomatic coronavirus disease 2019 (Covid-19) is unclear. Methods We conducted a randomized, controlled, adaptive platform trial involving predominantly vaccinated adults with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in Brazil and Canada. Outpatients who presented with an acute clinical condition consistent with Covid-19 within 7 days after the onset of symptoms received either pegylated interferon lambda (single subcutaneous injection, 180 μg) or placebo (single injection or oral). The primary composite outcome was hospitalization (or transfer to a tertiary hospital) or an emergency department visit (observation for >6 hours) due to Covid-19 within 28 days after randomization. Results A total of 933 patients were assigned to receive pegylated interferon lambda (2 were subsequently excluded owing to protocol deviations) and 1018 were assigned to receive placebo. Overall, 83% of the patients had been vaccinated, and during the trial, multiple SARS-CoV-2 variants had emerged. A total of 25 of 931 patients (2.7%) in the interferon group had a primary-outcome event, as compared with 57 of 1018 (5.6%) in the placebo group, a difference of 51% (relative risk, 0.49; 95% Bayesian credible interval, 0.30 to 0.76; posterior probability of superiority to placebo, >99.9%). Results were generally consistent in analyses of secondary outcomes, including time to hospitalization for Covid-19 (hazard ratio, 0.57; 95% Bayesian credible interval, 0.33 to 0.95) and Covid-19–related hospitalization or death (hazard ratio, 0.59; 95% Bayesian credible interval, 0.35 to 0.97). The effects were consistent across dominant variants and independent of vaccination status. Among patients with a high viral load at baseline, those who received pegylated interferon lambda had lower viral loads by day 7 than those who received placebo. The incidence of adverse events was similar in the two groups. Conclusions Among predominantly vaccinated outpatients with Covid-19, the incidence of hospitalization or an emergency department visit (observation for >6 hours) was significantly lower among those who received a single dose of pegylated interferon lambda than among those who received placebo. (Funded by FastGrants and others; TOGETHER ClinicalTrials.gov number, NCT04727424 .)

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ResumoA Escala de Risco Familiar de Coelho-Savassi, instrumento de estratificação de risco familiar, é aplicada às famílias adscritas a uma equipe de saúde da família, para determinar seu risco social e de saúde, refletindo o potencial de adoecimento de cada núcleo familiar. Utiliza dados presentes na ficha A do Sistema de Informações da Atenção Básica (SIAB) e outros identificáveis na rotina das equipes de saúde da família. Nas equipes em que foi aplicada, a escala mostrou-se útil na reorganização da demanda e promoveu um percepção mais apurada, objetiva e qualificada do risco das famílias avaliadas, impactando de maneira positiva o trabalho em equipe. A Escala é ainda uma ferramenta útil para o planejamento de ações na equipe, para a percepção da interrelação entre os fatores de risco, e como instrumento de apoio a intervenções no território. Além disso, ela corroborou, em nível local e microrregional, os dados do Índice de Vulnerabilidade à Saúde. Estas observações apontam para um amplo potencial de aplicação da Escala de Risco Familiar de Coelho e Savassi, e para a necessidade de sua sistematização e padronização, para ampliação de seu uso. Neste artigo, as sentinelas de risco foram avaliadas e discutidas pelos autores, resultando em uma definição clara e precisa dos termos, bem como a justificativa para a inserção de cada evento como um indicador a ser pontuado pela Escala. Foram definidos os critérios de pontuação para as famílias e sugeridas formas de aplicação prática da Escala nas equipes. Ao final, foram feitas recomendações sobre a aplicação em situações peculiares. AbstractThe Coelho-Savassi Family Risk Scale, a risk stratification family instrument, is applied to families ascribed to a family health team, to determine their social and health risk, reflecting the illness potential of each family. It uses data presented in the Primary Care Information System (SIAB) A form and other data identifiable in the routine of family health teams. In teams where it was applied, the scale proved itself as useful to reorganize the demand and promote a more accurate, objective and qualified perception of the families risks impacting positively the teamwork. The scale is still a useful tool for action planning in the team, to the perception of the interrelationship between risk factors, and as a tool to support interventions in the territory. Moreover, it corroborated in local and micro-regional levels, the data from the Health Vulnerability Index These observations point to a broad range of potential application of Coelho-Savassi Family Risk Scale, and the need for systematization and standardization, to broaden its application. In this article, the sentinels of risk were evaluated and discussed by the authors, resulting in a clear and precise definition of the terms, as well as the rationale for inclusion of each event as an indicator to be scored in the Scale. There were defined scoring criteria for families and suggested ways of practical implementation of Scale in teams. Finally, recommendations were made on th...

A Política Nacional de Atenção Domiciliar (PNAD) definiu três níveis de atenção domiciliar (AD), reconhecendo o primeiro nível (AD1) como responsabilidade das equipes de Atenção Primária à Saúde (APS). Ao longo da história, a legislação passou por alterações importantes e essa política representa a valorização dos serviços de APS como âmbito privilegiado do cuidado, sendo responsável pela maior parte dos cuidados em AD no Brasil. O cuidado no domicílio deve ser feito sob critérios de elegibilidade específicos, e um planejamento adequado. A visita domiciliar (VD) é um momento ímpar para o conhecimento do contexto da pessoa sob AD e deve se pautar pela observação ativa, pela abordagem da família e reconhecimento dos determinantes sociais presentes. Assim, é necessário que o profissional de saúde visitador tenha um rol de competências profissionais bem definidas, que em geral não são contempladas na graduação dos cursos de saúde, e de maneira insuficiente pelos cursos de pós-graduação. A PNAD representou um avanço ao reconhecer a APS como responsável pela AD1 numa lógica de cuidados contínuos crescentes, mas as lacunas no entendimento entre equipes de AD e APS, de formação profissional, e de sobrecarga de tarefas persistem. Este estudo apresenta uma análise crítica da implantação da PNAD até o momento, baseada na legislação vigente confrontada a prática das equipes de APS trabalhando no Sistema Único de Saúde.