December 2020

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December 31, 2020 (The New England Journal of Medicine)

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Fernando P. Polack, Stephen J. Thomas, Nicholas Kitchin et al.

http://doi.org/10.1056/NEJMoa2034577

BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a perfusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. In this ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, 21,720 participants received two doses, 21 days apart of the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 was 95% effective in preventing Covid-19 and similar vaccine efficacy was observed across various subgroups defined by demographics, BMI and presence of co-existing conditions. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. Safety over a median of 2 months was similar to that of other viral vaccines.

 

 

December 30, 2020 (The New England Journal of Medicine)

Maintaining Safety with SARS-CoV-2 Vaccines

Mariana C. Castells & Elizabeth J. Philips.​

In this review article, the authors summarize key findings of various SARS-CoV2 Vaccine trials with a focus on safety and adverse effects. They iterate that careful vaccine-safety surveillance over time, paired with elucidation of mechanisms of adverse events across different SARS-CoV-2 vaccine platforms, will be needed to inform a strategic and systematic approach to vaccine safety.

 

 

December 30, 2020 (The New England Journal of Medicine)

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

Lindsey R. Baden, Hana M. El Sahly, Brandon Essink et al.​

The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. 15,210 participants received 2 doses of the mRNA-1273 vaccine in phase 3 randomized, observer-blinded, placebo-controlled trial which was conducted at 99 centres across the United States. The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified.

 

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December 23, 2020 (EClinMed)

Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV2: A preliminary report of an open-label, Phase 1 clinical trial.

Pablo Tebas, ShuPing Yang, Jean D. Boyer et al.

https://doi.org/10.1016/j.eclinm.2020.100689

INO-4800 is a DNA vaccine targeting the full length spike antigen of SARS-CoV-2. Of the 38 human subjects who received both doses of the vaccine, immunogenicity was seen in 100% of them by eliciting either or both humoral or cellular immune responses. No serious adverse events were reported. INO-4800 demonstrated safety and tolerability.

 

 

December 23, 2020 (JAMA Netw. Open)

Assessment of Air Contamination by SARS-CoV-2 in Hospital Settings

Gabriel Birgand, Nathan Peiffer-Smadja, Sandra Fournier et al. https://doi.org/10.1001/jamanetworkopen.2020.33232

This systematic review distils the current evidence on air contamination with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in hospital settings and assesses the factors associated with contamination, including viral load and particle size.

 

 

December 22, 2020 (NEJM)

A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19

ACTIV-3/TICO LY-CoV555 Study Group

https://doi.org/10.1056/NEJMoa2033130

In this trial involving 314 hospitalized COVID-19 patients who were receiving remdesivir, those who received the monoclonal antibody LY-CoV555 did not have a better pulmonary function at day 5 than those who received placebo. The trial was stopped for futility.

 

 

December 18, 2020 (Science)

An ultrapotent synthetic nanobody neutralizes SARS-CoV-2 by stabilizing inactive Spike

Michael Schoof, Bryan Faust, Reuben A. Saunders et al.

https://doi.org/10.1126/science.abe3255

Monoclonal antibodies that bind to the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) show therapeutic promise but must be produced in mammalian cells and need to be delivered intravenously. By contrast, single-domain antibodies called nanobodies can be produced in bacteria or yeast, and their stability may enable aerosol delivery. Schoof et al. screened a yeast surface display of synthetic nanobodies and identified highly potent nanobodies that lock the spike protein in an inactive conformation.

 

 

December 18, 2020 (Nat Rev Immunol)

Viral targets for vaccines against COVID-19

Dai, L, Gao, G.F.​

Several vaccine candidates have been developed, several of which have completed late-stage clinical trials and are reporting positive results. In this Progress article, the authors discuss which viral elements are used in COVID-19 vaccine candidates, why they might act as good targets for the immune system and the implications for protective immunity.

 

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December 18, 2020 (Science)

People with Down syndrome face high risk from coronavirus

Meredith Wadman

https://doi.org/10.1126/science.370.6523.1384

The author summarizes the available data on the clinical severity and outcome of COVID-19 in patients with Down Syndrome, emphasizing the need for those with trisomy 21 to be prioritized for vaccination.

 

 

December 17, 2020 (NEJM)

REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19

David M. Weinreich, Sumathi Sivapalasingam, Thomas Norton et al.

https://doi.org/10.1056/NEJMoa2035002

An anti-SARS-CoV-2 antibody cocktail was given to patients within 3 days after diagnosis of COVID-19 by PCR. In patients who were antibody negative at baseline, treatment was associated with rapid viral clearance and potentially with a less frequent need for medical attention. The effect was less marked among patients who were antibody-positive at baseline.

 

 

December 17, 2020 (JAMA Otolaryngol Head Neck Surg.)

Early Outcomes From Early Tracheostomy for Patients With COVID-19

Kwak PE, Connors JR, Benedict PA, et al.

https://doi.org/10.1001/jamaoto.2020.4837

This cohort study assesses outcomes from early tracheostomy in the airway management of patients with COVID-19 requiring mechanical ventilation. The authors find that timing of tracheostomy was significantly associated with length of stay, suggesting that in patients with COVID-19, early tracheostomy was noninferior to late tracheostomy and may be associated with improvement in some outcomes

 

 

December 16, 2020 (Radiology: Artificial Intelligence)

Combining Initial Radiographs and Clinical Variables Improves Deep Learning Prognostication of Patients with COVID-19 from the Emergency Department

Young Joon (Fred) Kwon, Danielle Toussie, Mark Finkelstein et al.

https://doi.org/10.1148/ryai.2020200098

In this retrospective cohort study, the authors aimed to train a deep learning classification algorithm to predict chest radiography severity scores and clinical outcomes in patients with coronavirus disease 2019 (COVID-19). Chest Xrays of COVID-19 positive patients were examined for opacities and assigned a clinically validated severity score. Models were trained on the CXR severity score, on clinical variables and on both together. The authors found that the combination of imaging and clinical information improves outcome predictions.

 

 

December 15, 2020 (BMJ Nutrition, Prevention & Health)

Global, regional, and national estimates of target population sizes for COVID-19 vaccination: descriptive study

Wei Wang, Qianhui Wu, Juan Yang et al.

https://doi.org/10.1136/bmj.m4704

This descriptive study aims to provide global, regional, and national estimates of target population sizes for COVID-19 vaccination to inform country specific immunisation strategies on a global scale. The distribution of target groups at country and regional levels highlights the importance of designing an equitable and efficient plan for vaccine prioritisation and allocation. Each country should evaluate different strategies and allocation schemes based on local epidemiology, underlying population health, projections of available vaccine doses, and preference for vaccination strategies that favour direct or indirect benefits

 

 

December 14, 2020 (JAMA Netw. Open)

Household Transmission of SARS-CoV2: A Systematic Review and Meta-analysis

Madewell ZJ, Yang Y, Longini IM, Halloran ME, Dean NE. 

https://doi.org/10.1001/jamanetworkopen.2020.31756

This systematic review and meta-analysis examines the evidence for household transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), disaggregated by several covariates, and compares it with other coronaviruses

 

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December 10, 2020 (NEJM)

Efficacy of Tocilizumab in Patients Hospitalized with Covid-19

John H. Stone, Matthew J. Frigault, Naomi J. Serling-Boyd et al.

https://doi.org/10.1056/NEJMoa2028836

The efficacy of tocilizumab, an IL-6 receptor blocker, was tested in a randomized, controlled trial involving patients with COVID-19 who had fever, pulmonary infiltrates, or a need for supplemental oxygen. The authors found that the treatment had no significant effect on disease progression, independence from supplemental oxygen, or death.

 

 

December 10, 2020 (Int. J of Radiation Oncology*Biology*Physics)

Clinician attitudes to using low dose radiotherapy to treat COVID-19 lung disease

Catherine R. Hanna, Kathryn A. Robb, Kevin G. Blyth et al.

https://doi.org/10.1016/j.ijrobp.2020.12.003

Low dose radiotherapy (LDRT) has received both interest and criticism as a potential treatment for COVID-19 lung disease. In this qualitative study, the authors explored clinicians’ perspectives to identify barriers to testing LDRT in clinical trials and implementing them in clinical practice. The authors hope to address the barriers identified to facilitate research into the potential benefits of radiation treatment for patients with COVID-19 lung disease.

 

 

December 8, 2020 (The Lancet)

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Merryn Voysey, Sue Ann Costa Clemens, Shabir A Madhi et al.

​The authors evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four ongoing blinded, randomised, controlled trials across the UK, Brazil, and South Africa. Participants in the ChAdOx1 nCoV-19 group received two standard doses of the vaccine. The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after the second dose of vaccine. In this interim analysis of ongoing clinical trials, ChAdOx1 nCoV-19 has an acceptable safety profile and is efficacious against symptomatic COVID.

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December 8, 2020 (JAMA)

Peripheral Oxygen Saturation in Older Persons Wearing Nonmedical Face

Noel C. Chan, Karen Li, Jack Hirsh

​This study describes changes in portable oximeter–measured peripheral oxygen saturation (Spo2 or O2sat) in older adults before, during, and after wearing a 3-layer plane-shaped disposable nonmedical face mask widely used to protect against COVID-19. The authors found that wearing a 3-layer nonmedical face mask was not associated with a decline in oxygen saturation in older participants. Limitations to this study included small sample size, the exclusion of patients who were unable to wear a mask for medical reasons, investigation of only 1 type of mask and  Spo2 measurements during minimal physical activity.

 

 

December 8, 2020 (JAMA)

Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19

Eric J. Lenze, Caline Mattar, Charles F. Zorumski et al.

https://doi.org/10.1001/jama.2020.22760

This randomized trial compares the effects of fluvoxamine, a selective serotonin reuptake inhibitor with immunomodulatory effects vs placebo on a composite of dyspnoea or pneumonia and oxygen desaturation among adult outpatients with polymerase chain reaction–confirmed mild COVID-19 illness.

 

    

December 4, 2020 (Nat Commun)

Longitudinal symptom dynamics of COVID-19 infection

Mizrahi, B., Shilo, S., Rossman, H. et al

https://doi.org/10.1038/s41467-020-20053-y

The authors extracted data from primary-care electronic health records and nationwide distributed surveys to assess the longitudinal dynamics of symptoms before and throughout SARS-CoV-2 infection to better understand the full clinical spectrum of symptoms experienced by adults and children infected with COVID-19.

 

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December 4, 2020 (Science)

Comparative host-coronavirus protein interaction networks reveal pan-viral disease mechanisms

David E. Gordon, Joseph Hiatt, Mehdi Bouhaddou et al.

https://doi.org/10.1126/science.abe9403

Shedding light on the host factors taken over by the viruses, Gordon et al. mapped the interactions between viral and human proteins for SARS-CoV-2, SARS-CoV-1, and MERS-CoV. They analyzed the localization of viral proteins in human cells and used genetic screening to identify host factors that either enhance or inhibit viral infection.

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December 3, 2020 (Mayo Clinic Proceedings)

COVID-19: Understanding Inter-Individual Variability and Implications for Precision Medicine

Naveen L. Pereira, Ferhaan Ahmad, Mirnela Byku et al.

​There are demographic characteristics such as age, race, and ethnicity, and sex and biological differences such as ACE2 expression, immune regulation, and genetics that define the well-known variability in COVID-19 disease manifestation, susceptibility, and progression. Identifying and validating these individual differences and leveraging digital platforms including the use of artificial intelligence in developing predictive algorithms may help in individualizing targeted therapy and hospitalization and assist in the logistics of vaccine administration.

 

 

December 2, 2020 ( Singapore Medical Journal)

A review of COVID-19-related thrombosis and anticoagulation strategies specific to the Asian population

Kai Chin Poh, Victoria Yu Jia Tay, Sarah Huixin Lin et al.

https://doi.org/10.11622/smedj.2020174

Severe COVID-19 is widely regarded as a risk factor for venous thromboembolism. This review article aimed to summarise the current understanding of arteriovenous thromboembolic complications in COVID-19 and discuss management strategies for prevention and treatment of thrombotic events in Asian COVID-19 patients.  

 

 

December 2, 2020 (Diagn Interv Radiol)

Predictive value of CT imaging findings in COVID-19 pneumonia at the time of first-screen regarding the need for hospitalization or intensive care unit

Tekcan Sanli DE, Yildirim D, Sanli AN, et al.

https://doi.org/10.5152/dir.2020.20421

In this study, the authors aimed to reveal the relationship between initial lung parenchymal involvement patterns and the subsequent need for hospitalization and/or intensive care unit admission in COVID-19 positive cases. They found that in the case of infiltration dominated by a right middle or upper lobe involvement with a consolidation pattern, there is a higher risk of future intensive care need. Also, the need for intensive care increases as the number of affected lobes and the percentage of affected parenchymal involvement increase.

 

 

December 1, 2020 (JAMA Int. Med)

Seroprevalence of Antibodies to SARS-CoV-2 in 10 Sites in the United States, March 23-May 12, 2020

Fiona P. Havers, Carrie Reed, Travis Lim et al.

https://doi.org/10.1001/jamainternmed.2020.4130

This cross-sectional study estimates the prevalence of severe acute respiratory syndrome coronavirus 2 antibodies in convenience samples from 10 geographic sites in the United States.

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