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J Glob Health ; 10(2): 020354, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-1560886
Lancet Respir Med ; 9(5): 522-532, 2021 05.
Article in English | MEDLINE | ID: covidwho-1537199


BACKGROUND: Elevated proinflammatory cytokines are associated with greater COVID-19 severity. We aimed to assess safety and efficacy of sarilumab, an interleukin-6 receptor inhibitor, in patients with severe (requiring supplemental oxygen by nasal cannula or face mask) or critical (requiring greater supplemental oxygen, mechanical ventilation, or extracorporeal support) COVID-19. METHODS: We did a 60-day, randomised, double-blind, placebo-controlled, multinational phase 3 trial at 45 hospitals in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia, and Spain. We included adults (≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and pneumonia, who required oxygen supplementation or intensive care. Patients were randomly assigned (2:2:1 with permuted blocks of five) to receive intravenous sarilumab 400 mg, sarilumab 200 mg, or placebo. Patients, care providers, outcome assessors, and investigators remained masked to assigned intervention throughout the course of the study. The primary endpoint was time to clinical improvement of two or more points (seven point scale ranging from 1 [death] to 7 [discharged from hospital]) in the modified intention-to-treat population. The key secondary endpoint was proportion of patients alive at day 29. Safety outcomes included adverse events and laboratory assessments. This study is registered with, NCT04327388; EudraCT, 2020-001162-12; and WHO, U1111-1249-6021. FINDINGS: Between March 28 and July 3, 2020, of 431 patients who were screened, 420 patients were randomly assigned and 416 received placebo (n=84 [20%]), sarilumab 200 mg (n=159 [38%]), or sarilumab 400 mg (n=173 [42%]). At day 29, no significant differences were seen in median time to an improvement of two or more points between placebo (12·0 days [95% CI 9·0 to 15·0]) and sarilumab 200 mg (10·0 days [9·0 to 12·0]; hazard ratio [HR] 1·03 [95% CI 0·75 to 1·40]; log-rank p=0·96) or sarilumab 400 mg (10·0 days [9·0 to 13·0]; HR 1·14 [95% CI 0·84 to 1·54]; log-rank p=0·34), or in proportions of patients alive (77 [92%] of 84 patients in the placebo group; 143 [90%] of 159 patients in the sarilumab 200 mg group; difference -1·7 [-9·3 to 5·8]; p=0·63 vs placebo; and 159 [92%] of 173 patients in the sarilumab 400 mg group; difference 0·2 [-6·9 to 7·4]; p=0·85 vs placebo). At day 29, there were numerical, non-significant survival differences between sarilumab 400 mg (88%) and placebo (79%; difference +8·9% [95% CI -7·7 to 25·5]; p=0·25) for patients who had critical disease. No unexpected safety signals were seen. The rates of treatment-emergent adverse events were 65% (55 of 84) in the placebo group, 65% (103 of 159) in the sarilumab 200 mg group, and 70% (121 of 173) in the sarilumab 400 mg group, and of those leading to death 11% (nine of 84) were in the placebo group, 11% (17 of 159) were in the sarilumab 200 mg group, and 10% (18 of 173) were in the sarilumab 400 mg group. INTERPRETATION: This trial did not show efficacy of sarilumab in patients admitted to hospital with COVID-19 and receiving supplemental oxygen. Adequately powered trials of targeted immunomodulatory therapies assessing survival as a primary endpoint are suggested in patients with critical COVID-19. FUNDING: Sanofi and Regeneron Pharmaceuticals.

Antibodies, Monoclonal, Humanized , COVID-19 , Cytokine Release Syndrome , Receptors, Interleukin-6/antagonists & inhibitors , Respiratory Distress Syndrome , SARS-CoV-2/isolation & purification , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/adverse effects , COVID-19/complications , COVID-19/immunology , COVID-19/mortality , COVID-19/therapy , Critical Care/methods , Cytokine Release Syndrome/drug therapy , Cytokine Release Syndrome/etiology , Cytokine Release Syndrome/immunology , Dose-Response Relationship, Drug , Drug Monitoring/methods , Female , Humans , Immunologic Factors/administration & dosage , Immunologic Factors/adverse effects , International Cooperation , Male , Middle Aged , Mortality , Respiratory Distress Syndrome/diagnosis , Respiratory Distress Syndrome/etiology , Severity of Illness Index , Treatment Outcome
Perspect Public Health ; 141(3): 133-135, 2021 May.
Article in English | MEDLINE | ID: covidwho-1511683
Global Health ; 17(1): 128, 2021 11 06.
Article in English | MEDLINE | ID: covidwho-1505455


BACKGROUND: A special session of the World Health Assembly (WHA) will be convened in late 2021 to consider developing a WHO convention, agreement or other international instrument on pandemic preparedness and response - a so-called 'Pandemic Treaty'. Consideration is given to this treaty as well as to reform of the International Health Regulations (IHR) as our principal governing instrument to prevent and mitigate future pandemics. MAIN BODY: Reasons exist to continue to work with the IHR as our principal governing instrument to prevent and mitigate future pandemics. All WHO member states are party to it. It gives the WHO the authority to oversee the collection of surveillance data and to issue recommendations on trade and travel advisories to control the spread of infectious diseases, among other things. However, the limitations of the IHR in addressing the deep prevention of future pandemics also must be recognized. These include a lack of a regulatory framework to prevent zoonotic spillovers. More advanced multi-sectoral measures are also needed. At the same time, a pandemic treaty would have potential benefits and drawbacks as well. It would be a means of addressing the gross inequity in global vaccine distribution and other gaps in the IHR, but it would also need more involvement at the negotiation table of countries in the Global South, significant funding, and likely many years to adopt. CONCLUSIONS: Reform of the IHR should be undertaken while engaging with WHO member states (and notably those from the Global South) in discussions on the possible benefits, drawbacks and scope of a new pandemic treaty. Both options are not mutually exclusive.

International Health Regulations , Pandemics , Global Health , Humans , International Cooperation , Pandemics/prevention & control , World Health Organization
Elife ; 92020 06 08.
Article in English | MEDLINE | ID: covidwho-1497819


SARS-CoV-2 presents an unprecedented international challenge, but it will not be the last such threat. Here, we argue that the world needs to be much better prepared to rapidly detect, define and defeat future pandemics. We propose that a Global Immunological Observatory and associated developments in systems immunology, therapeutics and vaccine design should be at the heart of this enterprise.

Communicable Disease Control/organization & administration , Communicable Diseases, Emerging/prevention & control , Coronavirus Infections/epidemiology , Disaster Planning/organization & administration , Global Health , International Cooperation , Pandemics/prevention & control , Pneumonia, Viral/epidemiology , Population Surveillance , Animals , Anti-Infective Agents , COVID-19 , Climate Change , Cohort Studies , Communicable Disease Control/methods , Communicable Diseases, Emerging/diagnosis , Communicable Diseases, Emerging/epidemiology , Communicable Diseases, Emerging/immunology , Drug Development , Forecasting , Global Health/trends , Humans , Interdisciplinary Communication , Mass Screening/organization & administration , Models, Animal , Population Surveillance/methods , Serologic Tests , Vaccines , Weather , Zoonoses
J Law Med Ethics ; 49(3): 503-508, 2021.
Article in English | MEDLINE | ID: covidwho-1475209


Recognizing marked limitations of global health law in the COVID-19 pandemic, a rising number of states are supporting the development of a new pandemic treaty. This prospective treaty has the potential to clarify state obligations for pandemic preparedness and response and strengthen World Health Organization authorities to promote global health security. Examining the essential scope and content of a pandemic treaty, this column analyzes the policymaking processes and substantive authorities necessary to meet this historic moment.

COVID-19 , Pandemics , Global Health , Humans , International Cooperation , Pandemics/prevention & control , Prospective Studies , SARS-CoV-2
J Alzheimers Dis ; 83(4): 1563-1601, 2021.
Article in English | MEDLINE | ID: covidwho-1468319


Neurological disorders significantly impact the world's economy due to their often chronic and life-threatening nature afflicting individuals which, in turn, creates a global disease burden. The Group of Twenty (G20) member nations, which represent the largest economies globally, should come together to formulate a plan on how to overcome this burden. The Neuroscience-20 (N20) initiative of the Society for Brain Mapping and Therapeutics (SBMT) is at the vanguard of this global collaboration to comprehensively raise awareness about brain, spine, and mental disorders worldwide. This paper aims to provide a comprehensive review of the various brain initiatives worldwide and highlight the need for cooperation and recommend ways to bring down costs associated with the discovery and treatment of neurological disorders. Our systematic search revealed that the cost of neurological and psychiatric disorders to the world economy by 2030 is roughly $16T. The cost to the economy of the United States is $1.5T annually and growing given the impact of COVID-19. We also discovered there is a shortfall of effective collaboration between nations and a lack of resources in developing countries. Current statistical analyses on the cost of neurological disorders to the world economy strongly suggest that there is a great need for investment in neurotechnology and innovation or fast-tracking therapeutics and diagnostics to curb these costs. During the current COVID-19 pandemic, SBMT, through this paper, intends to showcase the importance of worldwide collaborations to reduce the population's economic and health burden, specifically regarding neurological/brain, spine, and mental disorders.

Global Burden of Disease , International Cooperation , Mental Disorders , Nervous System Diseases , COVID-19/epidemiology , Global Burden of Disease/organization & administration , Global Burden of Disease/trends , Global Health/economics , Global Health/trends , Humans , Mental Disorders/economics , Mental Disorders/epidemiology , Mental Disorders/therapy , Nervous System Diseases/economics , Nervous System Diseases/epidemiology , Nervous System Diseases/therapy , Neurosciences/methods , Neurosciences/trends , SARS-CoV-2
Br J Surg ; 108(10): 1162-1180, 2021 10 23.
Article in English | MEDLINE | ID: covidwho-1462296


BACKGROUND: Coronavirus disease 2019 (COVID-19) was declared a pandemic by the WHO on 11 March 2020 and global surgical practice was compromised. This Commission aimed to document and reflect on the changes seen in the surgical environment during the pandemic, by reviewing colleagues' experiences and published evidence. METHODS: In late 2020, BJS contacted colleagues across the global surgical community and asked them to describe how severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had affected their practice. In addition to this, the Commission undertook a literature review on the impact of COVID-19 on surgery and perioperative care. A thematic analysis was performed to identify the issues most frequently encountered by the correspondents, as well as the solutions and ideas suggested to address them. RESULTS: BJS received communications for this Commission from leading clinicians and academics across a variety of surgical specialties in every inhabited continent. The responses from all over the world provided insights into multiple facets of surgical practice from a governmental level to individual clinical practice and training. CONCLUSION: The COVID-19 pandemic has uncovered a variety of problems in healthcare systems, including negative impacts on surgical practice. Global surgical multidisciplinary teams are working collaboratively to address research questions about the future of surgery in the post-COVID-19 era. The COVID-19 pandemic is severely damaging surgical training. The establishment of a multidisciplinary ethics committee should be encouraged at all surgical oncology centres. Innovative leadership and collaboration is vital in the post-COVID-19 era.

COVID-19/prevention & control , Perioperative Care/trends , Practice Patterns, Physicians'/trends , Surgical Procedures, Operative/trends , Adult , Biomedical Research/organization & administration , COVID-19/diagnosis , COVID-19/economics , COVID-19/epidemiology , Education, Medical, Graduate/methods , Education, Medical, Graduate/trends , Female , Global Health , Health Resources/supply & distribution , Health Services Accessibility/trends , Humans , Infection Control/economics , Infection Control/methods , Infection Control/standards , International Cooperation , Male , Middle Aged , Pandemics , Perioperative Care/education , Perioperative Care/methods , Perioperative Care/standards , Practice Patterns, Physicians'/standards , Surgeons/education , Surgeons/psychology , Surgeons/trends , Surgical Procedures, Operative/education , Surgical Procedures, Operative/methods , Surgical Procedures, Operative/standards
PLoS Biol ; 19(10): e3001422, 2021 10.
Article in English | MEDLINE | ID: covidwho-1456048