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From the New England Journal of Medicine
An mRNA vaccine against SARS-CoV-2 — preliminary report: “We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg … After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40 227 in the 25-μg group, 109 209 in the 100-μg group, and 213 526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299 751, 782 719, and 1 192 154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events. Conclusions: The mRNA-1273 vaccine induced anti–SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine.”
https://www.nejm.org/doi/full/10.1056/NEJMoa2022483?query=featured_coronavirus
A randomized trial of hydroxychloroquine as postexposure prophylaxis for COVID-19: “The incidence of new illness compatible with COVID-19 [coronavirus disease 2019] did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was −2.4 percentage points (95% confidence interval, −7.0 to 2.2; P = 0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported. Conclusions: After high-risk or moderate-risk exposure to COVID-19, hydroxychloroquine did not prevent illness compatible with COVID-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure.”
https://www.nejm.org/doi/full/10.1056/NEJMoa2016638?query=featured_coronavirus
Observational study of hydroxychloroquine in hospitalized patients with COVID-19: “Hydroxychloroquine-treated patients were more severely ill at baseline than those who did not receive hydroxychloroquine (median ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen, 223 vs. 360). Overall, 346 patients (25.1%) had a primary end-point event (180 patients were intubated, of whom 66 subsequently died, and 166 died without intubation). In the main analysis, there was no significant association between hydroxychloroquine use and intubation or death (hazard ratio, 1.04, 95% confidence interval, 0.82 to 1.32). Results were similar in multiple sensitivity analyses. Conclusions: In this observational study involving patients with COVID-19 who had been admitted to the hospital, hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death.”
https://www.nejm.org/doi/full/10.1056/NEJMoa2012410?query=featured_coronavirus
From JAMA
Association between universal masking in a health care system and SARS-CoV-2 positivity among health care workers: “Of 9850 tested HCWs [health care workers], 1271 (12.9%) had positive results for SARS-CoV-2 (median age, 39 years; 73% female; 7.4% physicians or trainees, 26.5% nurses or physician assistants, 17.8% technologists or nursing support, and 48.3% other). During the preintervention period, the SARS-CoV-2 positivity rate increased exponentially from 0% to 21.32%, with a weighted mean increase of 1.16% per day and a case doubling time of 3.6 days (95% CI, 3.0-4.5 days). During the intervention period, the positivity rate decreased linearly from 14.65% to 11.46%, with a weighted mean decline of 0.49% per day and a net slope change of 1.65% (95% CI, 1.13%-2.15%; P < .001) more decline per day compared with the preintervention period. Conclusions: Universal masking at MGB was associated with a significantly lower rate of SARS-CoV-2 positivity among HCWs. This association may be related to a decrease in transmission between patients and HCWs and among HCWs. The decrease in HCW infections could be confounded by other interventions inside and outside of the health care system, such as restrictions on elective procedures, social distancing measures, and increased masking in public spaces, which are limitations of this study … Randomized trials of universal masking of HCWs during a pandemic are likely not feasible. Nonetheless, these results support universal masking as part of a multipronged infection reduction strategy in health care settings.”
https://jamanetwork.com/journals/jama/fullarticle/2768533
Factors associated with death in critically ill patients with coronavirus disease 2019 in the US: “In a cohort of 2215 adults with COVID-19 who were admitted to intensive care units at 65 sites, 784 (35.4%) died within 28 days, with wide variation among hospitals. Factors associated with death included older age, male sex, obesity, coronary artery disease, cancer, acute organ dysfunction, and admission to a hospital with fewer intensive care unit beds. Meaning: This study identified demographic, clinical, and hospital-level factors associated with death in critically ill patients with COVID-19 that may be used to facilitate the identification of medications and supportive therapies that can improve outcomes.”
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2768602
Outcomes of universal COVID-19 testing following detection of incident cases in 11 long-term care facilities: “In this study of 11 Maryland long-term care facilities, an additional 354 cases (39.6% of those tested) were identified with universal testing, despite initial targeted, symptom-based testing. These results underscore the importance of universal testing because symptom-based approaches may miss a substantial number of cases. Unrecognized asymptomatic cases among residents could perpetuate transmission within facilities. According to data from the Center for Medicare and Medicaid Services, the overall case fatality among residents of long-term care facilities is about 33%. The short-term mortality rate found in the present study among residents who underwent universal testing was much lower, suggesting that true COVID-associated mortality rates in long-term care facilities may be lowered by increased testing and case detection. Long-term care facilities have emerged as “hot spots” for SARS-CoV-2 infection and mortality globally. Using symptom-based testing alone to identify positive residents is not adequate to assess case burden and inform outbreak-control efforts in these settings. Additional testing resources are urgently needed to identify the true burden of COVID-19 and curb transmission in long-term care settings.”
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2768377
From The BMJ
Diagnostic accuracy of serological tests for COVID-19: systematic review and meta-analysis: “In summary, we have found major weaknesses in the evidence base for serological tests for COVID-19. The evidence does not support the continued use of existing point-of-care serological tests for COVID-19. While the scientific community should be lauded for the pace at which novel serological tests have been developed, this review underscores the need for high quality clinical studies to evaluate these tools. With international collaboration, such studies could be rapidly conducted and provide less biased, more precise, and more generalisable information on which to base clinical and public health policy to alleviate the unprecedented global health emergency that is COVID-19.”
https://www.bmj.com/content/370/bmj.m2516
From the MJA
An evaluation of the quality and impact of the global research response to the COVID-19 pandemic: “While the global research response to COVID-19 has been rapid and substantial, many studies of interventions may not lead to high-quality evidence to guide treatment of COVID-19, due to methodological insufficiencies. There was significant duplication with multiple trials of several interventions. The impact on non-COVID-19 research has been substantial.”
COVID-19 safety: aerosol generating procedures and cardiothoracic surgery and anaesthesia: “Controversies exist with regard to the management of low-risk patients undergoing procedures, which are at high risk of [aerosol generation], and recommendations for these patients will change depending on the regional prevalence, risk of community transmission and the potential for asymptomatic patients attending for these procedures.”
Efficacy of an enclosure to reduce aerosol exposure during simulated intubation: “Our data suggest that such an enclosure, which is readily improvised, may reduce the chance of high level aerosol exposure occurring during intubation. The protection provided was not complete and appropriate [personal protective equipment] should still be worn. Although we did not observe any of the difficulties that have been reported with a rigid enclosure, the method is a departure from conventional practice and should be first attempted under controlled conditions.”
All MJA COVID-19 articles are available here, and all are open access.
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Surely wearing a mask in a hot zone or non social distancing environment is a small price to pay for a more rapid escape from this current pandemic. Looking around the world at countries with right wing leaders it seems to me that not wearing masks is a politically/ideologically led phenomena that has severely affected populations and economies.
Aboard the USS Theodore Roosevelt aircraft carrier it was found that those who took preventive measures such as social distancing and face masks were less likely to become infected by COVID- 19.
Only 55.8 percent of those who wore masks became infected compared with 80.7 percent who did not. Of those who practised physical distancing,54.7 had been infected compared with 70 percent of those who did not.
More than 1000 of the crew of 4900 tested positive for COVID-19.
There is definite evidence that masks reduce infection, but I see no need to enforce the wearing of masks outside enclosed premises. It is essential that they are worn correctly.