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1.
Rev Bras Ter Intensiva ; 34(1): 1-12, 2022.
Article in Portuguese, English | MEDLINE | ID: covidwho-1893271

ABSTRACT

OBJECTIVE: Several therapies are being used or proposed for COVID-19, and many lack appropriate evaluations of their effectiveness and safety. The purpose of this document is to develop recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil. METHODS: A group of 27 experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method. RESULTS: Sixteen recommendations were generated. They include strong recommendations for the use of corticosteroids in patients using supplemental oxygen, the use of anticoagulants at prophylactic doses to prevent thromboembolism and the nonuse of antibiotics in patients without suspected bacterial infection. It was not possible to make a recommendation regarding the use of tocilizumab in patients hospitalized with COVID-19 using oxygen due to uncertainties regarding the availability of and access to the drug. Strong recommendations against the use of hydroxychloroquine, convalescent plasma, colchicine, lopinavir + ritonavir and antibiotics in patients without suspected bacterial infection and also conditional recommendations against the use of casirivimab + imdevimab, ivermectin and rendesivir were made. CONCLUSION: To date, few therapies have proven effective in the treatment of hospitalized patients with COVID-19, and only corticosteroids and prophylaxis for thromboembolism are recommended. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and promote economical resource use.


OBJETIVOS: Há diversas terapias sendo utilizadas ou propostas para a COVID-19, muitas carecendo de apropriada avaliação de efetividade e segurança. O propósito deste documento é elaborar recomendações para subsidiar decisões sobre o tratamento farmacológico de pacientes hospitalizados com COVID-19 no Brasil. MÉTODOS: Um grupo de 27 membros, formado por especialistas, representantes do Ministério da Saúde e metodologistas, integra essa diretriz. Foi utilizado o método de elaboração de diretrizes rápidas, tomando por base a adoção e/ou a adaptação de recomendações a partir de diretrizes internacionais existentes (GRADE ADOLOPMENT), apoiadas pela plataforma e-COVID-19 RecMap. A qualidade das evidências e a elaboração das recomendações seguiram o método GRADE. RESULTADOS: Foram geradas 16 recomendações. Entre elas, estão recomendações fortes para o uso de corticosteroides em pacientes em uso de oxigênio suplementar, para o uso de anticoagulantes em doses de profilaxia para tromboembolismo e para não uso de antibacterianos nos pacientes sem suspeita de infecção bacteriana. Não foi possível fazer uma recomendação quanto à utilização do tocilizumabe em pacientes hospitalizados com COVID-19 em uso de oxigênio, pelas incertezas na disponibilidade e de acesso ao medicamento. Foi feita recomendação para não usar azitromicina, casirivimabe + imdevimabe, cloroquina, colchicina, hidroxicloroquina, ivermectina, lopinavir/ ritonavir, plasma convalescente e rendesivir. CONCLUSÃO: Até o momento, poucas terapias se provaram efetivas no tratamento do paciente hospitalizado com COVID-19, sendo recomendados apenas corticosteroides e profilaxia para tromboembolismo. Diversos medicamentos foram considerados ineficazes, devendo ser descartados, de forma a oferecer o melhor tratamento pelos princípios da medicina baseada em evidências e promover economia de recursos não eficazes.


Subject(s)
COVID-19 , Thromboembolism , Adrenal Cortex Hormones/therapeutic use , Anti-Bacterial Agents , Antibodies, Monoclonal, Humanized , Brazil , COVID-19/drug therapy , COVID-19/therapy , Humans , Immunization, Passive , Oxygen
2.
Chest ; 161(6): 1526-1542, 2022 06.
Article in English | MEDLINE | ID: covidwho-1704181

ABSTRACT

BACKGROUND: Brazil has been disproportionately affected by COVID-19, placing a high burden on ICUs. RESEARCH QUESTION: Are perceptions of ICU resource availability associated with end-of-life decisions and burnout among health care providers (HCPs) during COVID-19 surges in Brazil? STUDY DESIGN AND METHODS: We electronically administered a survey to multidisciplinary ICU HCPs during two 2-week periods (in June 2020 and March 2021) coinciding with COVID-19 surges. We examined responses across geographical regions and performed multivariate regressions to explore factors associated with reports of: (1) families being allowed less input in decisions about maintaining life-sustaining treatments for patients with COVID-19 and (2) emotional distress and burnout. RESULTS: We included 1,985 respondents (57% physicians, 14% nurses, 12% respiratory therapists, 16% other HCPs). More respondents reported shortages during the second surge compared with the first (P < .05 for all comparisons), including lower availability of intensivists (66% vs 42%), ICU nurses (53% vs 36%), ICU beds (68% vs 22%), and ventilators for patients with COVID-19 (80% vs 70%); shortages were highest in the North. One-quarter of HCPs reported that families were allowed less input in decisions about maintaining life-sustaining treatments for patients with COVID-19, which was associated with lack of intensivists (adjusted relative risk [aRR], 1.37; 95% CI, 1.05-1.80) and ICU beds (aRR, 1.71; 95% CI, 1.16-2.62) during the first surge and lack of N95 masks (aRR, 1.43; 95% CI, 1.10-1.85), noninvasive positive pressure ventilation (aRR, 1.56; 95% CI, 1.18-2.07), and oxygen concentrators (aRR, 1.50; 95% CI, 1.13-2.00) during the second surge. Burnout was higher during the second surge (60% vs 71%; P < .001), associated with witnessing colleagues at one's hospital contract COVID-19 during both surges (aRR, 1.55 [95% CI, 1.25-1.93] and 1.31 [95% CI, 1.11-1.55], respectively), as well as worries about finances (aRR, 1.28; 95% CI, 1.02-1.61) and lack of ICU nurses (aRR, 1.25; 95% CI, 1.02-1.53) during the first surge. INTERPRETATION: During the COVID-19 pandemic, ICU HCPs in Brazil experienced substantial resource shortages, health care disparities between regions, changes in end-of-life care associated with resource shortages, and high proportions of burnout.


Subject(s)
Burnout, Professional , COVID-19 , Brazil/epidemiology , Burnout, Professional/epidemiology , Burnout, Professional/therapy , COVID-19/epidemiology , COVID-19/therapy , Critical Care , Health Personnel , Humans , Intensive Care Units , Pandemics , Surveys and Questionnaires
3.
Open forum infectious diseases ; 8(Suppl 1):S382-S383, 2021.
Article in English | EuropePMC | ID: covidwho-1602234

ABSTRACT

Background Key pathologies in severe COVID-19 include immune cell activation, inflammatory cytokine release, and neutrophil extracellular trap release (NETosis), which are mediated by spleen tyrosine kinase (SYK) (Figure 1). Fostamatinib, an oral SYK inhibitor approved for chronic immune thrombocytopenia, has shown activity in vitro using plasma from patients with severe COVID-19, by abrogating the hyperimmune response triggered by anti-spike IgG; 1 inhibiting hyperactivation in platelets; 2 and blocking NETosis in neutrophils.3 R406, active metabolite of fostamatinib, protected against LPS-induced acute lung injury and thrombosis in mice.4,5 In clinical studies, fostamatinib reduced IL-6 in patients with rheumatoid arthritis.6 Therefore, a phase 2 study (NCT04579393) evaluated fostamatinib vs. placebo plus standard of care (SOC) in 59 hospitalized COVID-19 patients (manuscript pending). We initiated a phase 3 clinical study (NCT04629703) of fostamatinib for the treatment of COVID-19. Methods A double-blind, randomized, placebo-controlled, adaptive design, multi-center, Phase 3 study (NCT04629703) is underway to evaluate the safety and efficacy of fostamatinib in 308 adult patients with COVID-19 (Figure 2). Hospitalized patients without respiratory failure (with or without supplemental oxygen) were included. Patients with ARDS or using extracorporeal membrane oxygenation (ECMO) were excluded. Patients will receive fostamatinib 150 mg BID or placebo for 14 days;both arms receive SOC. The primary outcome will be progression to severe/critical disease (worsening in clinical status score on the 8-point ordinal scale) within 29 days of the first dose of study drug. Fostamatinib is investigational for COVID-19. Results Blinded update of trial in progress as of 28 April 2021. 12 patients have been randomized in North and South America. The clinical status score at Baseline was 5 (Hospitalized, requiring supplemental oxygen) in all 12 patients. Five patients had 8 adverse events (AE) (Fig 3). One AE (PE) was serious and is resolving. No deaths have been reported. At least two patients have been discharged (Day 5, Day 13) with continued dosing at home. Conclusion Fostamatinib has the potential to provide a treatment option for the hyperimmune complications of COVID-19. Disclosures Ziad Mallat, MD, PhD, Rigel Pharmaceuticals, Inc. (Consultant) Sandra Tong, MD, Rigel Pharmaceuticals, Inc. (Employee, Shareholder)

4.
Crit Care Med ; 49(11): 1974-1982, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1475880
5.
Intensive Care Med ; 47(11): 1258-1270, 2021 11.
Article in English | MEDLINE | ID: covidwho-1449953

ABSTRACT

PURPOSE: Trials of tocilizumab in patients with severe COVID-19 pneumonia have demonstrated mixed results, and the role of tocilizumab in combination with other treatments is uncertain. Here we evaluated whether tocilizumab plus remdesivir provides greater benefit than remdesivir alone in patients with severe COVID-19 pneumonia. METHODS: This randomized, double-blind, placebo-controlled, multicenter trial included patients hospitalized with severe COVID-19 pneumonia requiring > 6 L/min supplemental oxygen. Patients were randomly assigned (2:1 ratio) to receive tocilizumab 8 mg/kg or placebo intravenously plus ≤ 10 days of remdesivir. The primary outcome was time from randomization to hospital discharge or "ready for discharge" (defined as category 1, assessed by the investigator on a 7-category ordinal scale of clinical status) to day 28. Patients were followed for 60 days. RESULTS: Among 649 enrolled patients, 434 were randomly assigned to tocilizumab plus remdesivir and 215 to placebo plus remdesivir. 566 patients (88.2%) received corticosteroids during the trial to day 28. Median time from randomization to hospital discharge or "ready for discharge" was 14 (95% CI 12-15) days with tocilizumab plus remdesivir and 14 (95% CI 11-16) days with placebo plus remdesivir [log-rank P = 0.74; Cox proportional hazards ratio 0.97 (95% CI 0.78-1.19)]. Serious adverse events occurred in 128 (29.8%) tocilizumab plus remdesivir and 72 (33.8%) placebo plus remdesivir patients; 78 (18.2%) and 42 (19.7%) patients, respectively, died by day 28. CONCLUSIONS: Tocilizumab plus remdesivir did not shorten time to hospital discharge or "ready for discharge" to day 28 compared with placebo plus remdesivir in patients with severe COVID-19 pneumonia.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Antimetabolites/therapeutic use , Antiviral Agents , COVID-19 , Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antiviral Agents/therapeutic use , COVID-19/drug therapy , Humans
7.
Viruses ; 13(7)2021 06 26.
Article in English | MEDLINE | ID: covidwho-1289023

ABSTRACT

The rapid development of efficacious and safe vaccines against coronavirus disease 2019 (COVID-19) has been instrumental in mitigating the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Moreover, the emergence of SARS-CoV-2 variants raised concerns on the efficacy of these vaccines. Herein, we report two cases of breakthrough infections with the P1 variant in patients vaccinated with CoronaVac, which is one of the two vaccines authorized for emergency use in the Brazilian immunization program. Our observations suggest that the vaccine reduced the severity of the disease and highlight the potential risk of illness following vaccination and subsequent infection with the P1 variant as well as for continued efforts to prevent and diagnose infection in vaccinated persons.


Subject(s)
Antibodies, Viral/blood , COVID-19 Vaccines/immunology , COVID-19/diagnostic imaging , COVID-19/immunology , SARS-CoV-2/immunology , Vaccination/adverse effects , Brazil , COVID-19/drug therapy , COVID-19/prevention & control , COVID-19 Nucleic Acid Testing , COVID-19 Vaccines/administration & dosage , Clinical Trials as Topic , Dexamethasone/therapeutic use , Humans , Male , Middle Aged , SARS-CoV-2/genetics , Severity of Illness Index , Tomography, X-Ray Computed , Treatment Outcome , Vaccination/statistics & numerical data
8.
J Med Virol ; 93(3): 1770-1775, 2021 03.
Article in English | MEDLINE | ID: covidwho-1196472

ABSTRACT

Herein, we report a case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and dengue coinfection, presented as a fatal stroke in our hospital, in São José do Rio Preto, São Paulo State, a Brazilian city hyperendemic for dengue viruses and other arthropod-borne viruses (arboviruses) and currently facing a surge of SARS-CoV-2 cases. This case is the first described in the literature and contributes to the better understanding of clinical presentations of two important diseases in a tropical setting.


Subject(s)
COVID-19/complications , Coinfection/complications , Dengue Virus/pathogenicity , Dengue/complications , SARS-CoV-2/pathogenicity , Stroke/etiology , Stroke/virology , Arboviruses/pathogenicity , Brazil , COVID-19/virology , Coinfection/virology , Dengue/virology , Female , Humans , Middle Aged
9.
J Med Virol ; 93(3): 1770-1775, 2021 03.
Article in English | MEDLINE | ID: covidwho-1001928

ABSTRACT

Herein, we report a case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and dengue coinfection, presented as a fatal stroke in our hospital, in São José do Rio Preto, São Paulo State, a Brazilian city hyperendemic for dengue viruses and other arthropod-borne viruses (arboviruses) and currently facing a surge of SARS-CoV-2 cases. This case is the first described in the literature and contributes to the better understanding of clinical presentations of two important diseases in a tropical setting.


Subject(s)
COVID-19/complications , Coinfection/complications , Dengue Virus/pathogenicity , Dengue/complications , SARS-CoV-2/pathogenicity , Stroke/etiology , Stroke/virology , Arboviruses/pathogenicity , Brazil , COVID-19/virology , Coinfection/virology , Dengue/virology , Female , Humans , Middle Aged
10.
J. bras. nefrol ; 42(2,supl.1):22-31, 2020.
Article in English | LILACS (Americas), Grey literature | ID: grc-742962

ABSTRACT

ABSTRACT We produced this document to bring pertinent information to the practice of nephrology, as regards to the renal involvement with COVID-19, the management of acute kidney injury cases, and practical guidance on the provision of dialysis support.As information on COVID-19 evolves at a pace never before seen in medical science, these recommendations, although based on recent scientific evidence, refer to the present moment. The guidelines may be updated when published data and other relevant information become available. RESUMO Este documento foi desenvolvido para trazer informações pertinentes à prática nefrológica em relação ao conhecimento sobre o acometimento renal da COVID-19, conduta frente aos casos de injúria renal aguda e orientações práticas sobre a provisão do suporte dialítico.Como as informações sobre a COVID-19 evoluem a uma velocidade jamais vista na ciência médica, as orientações apresentadas, embora baseadas em evidências científicas recentes, referem-se ao momento presente. Essas orientaços poderão ser atualizadas à medida que dados publicados e outras informações relevantes venham a ser disponibilizadas.

11.
J. bras. nefrol ; 42(2,supl.1): 22-31, 2020. tab
Article in English | WHO COVID, LILACS (Americas) | ID: covidwho-740462

ABSTRACT

ABSTRACT We produced this document to bring pertinent information to the practice of nephrology, as regards to the renal involvement with COVID-19, the management of acute kidney injury cases, and practical guidance on the provision of dialysis support.As information on COVID-19 evolves at a pace never before seen in medical science, these recommendations, although based on recent scientific evidence, refer to the present moment. The guidelines may be updated when published data and other relevant information become available.


RESUMO Este documento foi desenvolvido para trazer informações pertinentes à prática nefrológica em relação ao conhecimento sobre o acometimento renal da COVID-19, conduta frente aos casos de injúria renal aguda e orientações práticas sobre a provisão do suporte dialítico.Como as informações sobre a COVID-19 evoluem a uma velocidade jamais vista na ciência médica, as orientações apresentadas, embora baseadas em evidências científicas recentes, referem-se ao momento presente. Essas orientaços poderão ser atualizadas à medida que dados publicados e outras informações relevantes venham a ser disponibilizadas.


Subject(s)
Humans , Pneumonia, Viral/epidemiology , Renal Replacement Therapy/standards , Coronavirus Infections/epidemiology , Acute Kidney Injury/therapy , Vascular Access Devices/standards , Betacoronavirus , Respiration, Artificial/adverse effects , Societies, Medical , Brazil/epidemiology , Coronavirus Infections/prevention & control , Coronavirus Infections/drug therapy , Recovery of Function , Critical Care , Acute Kidney Injury/etiology , Acute Kidney Injury/epidemiology , Clinical Decision-Making , SARS-CoV-2 , COVID-19 , Occupational Diseases/prevention & control
12.
Anaesth Crit Care Pain Med ; 39(5): 563-569, 2020 10.
Article in English | MEDLINE | ID: covidwho-696277

ABSTRACT

PURPOSE: To survey haemodynamic monitoring and management practices in intensive care patients with the coronavirus disease 2019 (COVID-19). METHODS: A questionnaire was shared on social networks or via email by the authors and by Anaesthesia and/or Critical Care societies from France, Switzerland, Belgium, Brazil, and Portugal. Intensivists and anaesthetists involved in COVID-19 ICU care were invited to answer 14 questions about haemodynamic monitoring and management. RESULTS: Globally, 1000 questionnaires were available for analysis. Responses came mainly from Europe (n = 460) and America (n = 434). According to a majority of respondents, COVID-19 ICU patients frequently or very frequently received continuous vasopressor support (56%) and had an echocardiography performed (54%). Echocardiography revealed a normal cardiac function, a hyperdynamic state (43%), hypovolaemia (22%), a left ventricular dysfunction (21%) and a right ventricular dilation (20%). Fluid responsiveness was frequently assessed (84%), mainly using echo (62%), and cardiac output was measured in 69%, mostly with echo as well (53%). Venous oxygen saturation was frequently measured (79%), mostly from a CVC blood sample (94%). Tissue perfusion was assessed biologically (93%) and clinically (63%). Pulmonary oedema was detected and quantified mainly using echo (67%) and chest X-ray (61%). CONCLUSION: Our survey confirms that vasopressor support is not uncommon in COVID-19 ICU patients and suggests that different haemodynamic phenotypes may be observed. Ultrasounds were used by many respondents, to assess cardiac function but also to predict fluid responsiveness and quantify pulmonary oedema. Although we observed regional differences, current international guidelines were followed by most respondents.


Subject(s)
Betacoronavirus , Coronavirus Infections/therapy , Critical Care/methods , Health Care Surveys , Hemodynamic Monitoring , Pandemics , Pneumonia, Viral/therapy , Africa/epidemiology , Americas/epidemiology , Asia/epidemiology , Australia/epidemiology , COVID-19 , Cardiotonic Agents/therapeutic use , Coronavirus Infections/complications , Coronavirus Infections/epidemiology , Coronavirus Infections/physiopathology , Disease Management , Echocardiography/statistics & numerical data , Europe/epidemiology , Fluid Therapy , Hemodynamics/drug effects , Humans , Oxygen/blood , Pneumonia, Viral/complications , Pneumonia, Viral/epidemiology , Pneumonia, Viral/physiopathology , Procedures and Techniques Utilization , Pulmonary Edema/etiology , Pulmonary Edema/physiopathology , SARS-CoV-2 , Shock/etiology , Shock/physiopathology , Vasoconstrictor Agents/therapeutic use
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