Coronavirus COVID-19 Update for May 14, 2021

Clinical Reports

Non-steroidal anti-inflammatory drug use and outcomes of COVID-19 in the ISARIC Clinical Characterisation Protocol UK cohort: a matched, prospective cohort study
Early in the pandemic it was suggested that pre-existing use of non-steroidal anti-inflammatory drugs (NSAIDs) could lead to increased disease severity in patients with COVID-19. NSAIDs are an important analgesic, particularly in those with rheumatological disease, and are widely available to the general public without prescription. Purpose of this study was to characterise the safety of NSAIDs and identify whether pre-existing NSAID use was associated with increased severity of COVID-19 disease. This prospective, multicentre cohort study included patients of any age admitted to hospital with a confirmed or highly suspected SARS-CoV-2 infection leading to COVID-19 between Jan 17 and Aug 10, 2020. The primary outcome was in-hospital mortality, and secondary outcomes were disease severity at presentation, admission to critical care, receipt of invasive ventilation, receipt of non-invasive ventilation, use of supplementary oxygen, and acute kidney injury. NSAID use was required to be within the 2 weeks before hospital admission. Between Jan 17 and Aug 10, 2020, 78 674 patients were enrolled across 255 health-care facilities in England, Scotland, and Wales. 72 179 patients had death outcomes available for matching; 40 406 (56·2%) of 71 915 were men, 31 509 (43·8%) were women. In this cohort, 4211 (5·8%) patients were recorded as taking systemic NSAIDs before admission to hospital. Following propensity score matching, balanced groups of NSAIDs users and NSAIDs non-users were obtained (4205 patients in each group). At hospital admission, we observed no significant differences in severity between exposure groups. After adjusting for explanatory variables, NSAID use was not associated with worse in-hospital mortality (matched OR 0·95, 95% CI 0·84–1·07; p=0·35), critical care admission (1·01, 0·87–1·17; p=0·89), requirement for invasive ventilation (0·96, 0·80–1·17; p=0·69), requirement for non-invasive ventilation (1·12, 0·96–1·32; p=0·14), requirement for oxygen (1·00, 0·89–1·12; p=0·97), or occurrence of acute kidney injury (1·08, 0·92–1·26; p=0·33). NSAID use is not associated with higher mortality or increased severity of COVID-19. Policy makers should consider reviewing issued advice around NSAID prescribing and COVID-19 severity.

Post coronavirus disease mucormycosis: a deadly addition to the pandemic spectrum
Purpose of this study was to address the possible association between invasive fungal sinusitis (mucormycosis) and coronavirus disease. A prospective observational study was conducted at a tertiary care centre over four months, involving all patients with mucormycosis of the paranasal sinuses suffering from or having a history of coronavirus disease infection. Twenty-three patients presented with mucormycosis, all had an association with coronavirus disease 2019. The ethmoids (100 per cent) were the most common sinuses affected. Intra-orbital extension was seen in 43.47 per cent of cases, while intracranial extension was only seen in 8.69 per cent. Diabetes mellitus was present in 21 of 23 cases, and was uncontrolled in 12 cases. All patients had a history of steroid use during their coronavirus treatment. New manifestations of

Antiviral Therapeutics and Vaccines

Moderna reports COVID-19 vaccine for teens safe, effective
Moderna’s COVID-19 vaccine is 96% effective for adolescents ages 12-17 years and has no serious safety concerns, the company announced Thursday. The preliminary data come from trials of 3,235 participants who were randomized to receive a vaccine or placebo. Twelve cases of COVID-19 were reported but no additional details were provided. The most common side effects include injection site pain, headache, fatigue, myalgia and chills. Moderna said it is discussing its teen data with regulators, but did not provide additional details on a projected timeline for requesting Food and Drug Administration (FDA) approval. It also is continuing to study its vaccine in children ages 6 months to 11 years. Moderna leaders said Thursday they plan to request full licensure from the FDA later this month. The company also is studying booster doses and the possibility its current vaccine formulation could be stored at refrigerator temperatures for three months instead of one.

Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic
The U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older. From March 1, 2020 through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC). Children and adolescents generally have a milder COVID-19 disease course as compared to adults. The Pfizer-BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older.The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.

Epidemiology

•Outdoor Transmission of SARS-CoV-2 and Other Respiratory Viruses: A Systematic Review While risk of outdoor transmission of respiratory viral infections is hypothesized to be low, there are limited data on SARS-CoV-2 transmission in outdoor compared to indoor settings Methods
Authors conducted a systematic review of peer-reviewed papers indexed in PubMed, EMBASE, and Web of Science and preprints in Europe PMC through 12 August 2020 that described cases of human transmission of SARS-CoV-2. Reports of other respiratory virus transmission were included for reference. Five identified studies found a low proportion of reported global SARS-CoV-2 infections occurred outdoors (<10%) and the odds of indoor transmission was very high compared to outdoors (18.7 times; 95% confidence interval, 6.0–57.9). Five studies described influenza transmission outdoors and 2 adenovirus transmission outdoors. There was high heterogeneity in study quality and individual definitions of outdoor settings, which limited the ability to draw conclusions about outdoor transmission risks. In general, factors such as duration and frequency of personal contact, lack of personal protective equipment, and occasional indoor gathering during a largely outdoor experience were associated with outdoor reports of infection. Existing evidence supports the wide-held belief that risk of SARS-CoV-2 transmission is lower outdoors but there are significant gaps in our understanding of specific pathways.