Guidance for Healthcare Providers on Newest Guidelines for Over-the-Counter Drug Treatment of Mild Symptoms of COVID-19.

On January 18, 2024, the US Centers for Disease Control and Prevention issued their most recent guidelines for over-the-counter drugs for coronavirus disease 2019 (COVID-19). Specifically, the organization stated that "Most people with COVID-19 have mild illness and can recover at home. You can treat symptoms with over-the-counter medicines, such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil), to help you feel better." In this review we consider the contributions of different types of evidence and conclude that healthcare providers should make individual clinical judgments for each of their patients in the selection of over-the-counter drugs to treat symptoms of COVID-19. This judgment should be based on the entire benefit to risk profile of the patient. It is our belief that the individual healthcare provider knows far more about each of his or her patients than anyone, including expert members of guideline committees. Their astute and judicious individual clinical decision-making for each individual patient based on all these considerations has the potential to do far more good than harm.

Emerging data in COVID-19 create urgent challengers for health providers: Updates on COVID-19 vaccine and Paxlovid.

In this original research we present new emerging data in COVID-19 that create urgent challenges for health providers in prevention and treatment. Health providers should be aware that COVID-19 cases, hospitalizations, and deaths have increased markedly in August 2023. Further, recent data demonstrate a new emerging strain resistant to prior natural and vaccine immunity. The most recent emerging data show that only this updated COVID-19 vaccine produces the same immune response as previous vaccines that reduced mortality by over 95 % and morbidity by over 99 %. This recommendation encompasses all adults and children aged 6 months and older, regardless of whether they have had a prior COVID-19 infection or even if they have never received a prior vaccination. This updated COVID-19 vaccine, approved in September 2023, will be the best means to prevent COVID-19 during this upcoming season of respiratory viruses. In the meanwhile, all members of the US population regardless of previous natural infection, vaccines, or boosters are equally susceptible. At present, health providers should counsel all their patients about masking, social distancing, and avoiding crowds, especially indoors where regions of extreme weather conditions are keeping people indoors in closed quarters. In the treatment of COVID-19 the major clinical challenge to health providers, especially in their Black patients, is to prescribe Paxlovid during the first 5 days after onset of symptoms and a positive test.

In complicated UTI or pyelonephritis, cefepime-enmetazobactam increased success vs. piperacillin-tazobactam at 14 d.

SOURCE CITATION: Kaye KS, Belley A, Barth P, et al. Effect of cefepime/enmetazobactam vs piperacillin/tazobactam on clinical cure and microbiological eradication in patients with complicated urinary tract infection or acute pyelonephritis: a randomized clinical trial. JAMA. 2022;328:1304-14. 36194218.

Ivermectin in COVID-19: The Case for a Moratorium on Prescriptions.

In treatment or prevention of COVID-19, ivermectin is not approved by the United States (US) Food and Drug Administration (FDA). Nonetheless, in the US, prescriptions of ivermectin by healthcare providers have increased > tenfold from 3589 per week pre-COVID-19 to 39,102. Ivermectin is FDA approved for animals to treat parasites and for humans to treat intestinal strongyloidiasis and onchocerciasis orally, and ectoparasites and skin conditions topically. It is not a benign drug, with reported side effects including cutaneous, gastrointestinal, and cardiovascular symptoms. The evidence to support ivermectin to treat or prevent COVID-19 includes some basic research and inconsistent clinical observations that contribute to the formulation of a hypothesis of efficacy in COVID-19. At present, data from peer-reviewed published randomized trials of sufficient size, dose, and duration to reliably test the hypothesis of the most plausible small to moderate benefits on clinically relevant endpoints are sparse. In addition to the US FDA, the US National Institutes of Health, World Health Organization, and European Medicines Agency have all advised against ivermectin for treatment or prevention of COVID-19 outside of randomized trials. For ivermectin in treatment or prevention of COVID-19, healthcare providers should reassure all patients that if sufficient evidence were to emerge, then this drug could be considered a therapeutic innovation and regulatory authorities would approve the drug. In the meanwhile, we strongly recommend a moratorium on the prescription of ivermectin for the treatment or prevention of COVID-19 except in randomized trials to provide the most reliable test of the hypothesis.

Recommendations were made for diagnosis and management of allergic reactions to COVID-19 vaccines.

SOURCE CITATION: Greenhawt M, Abrams EM, Shaker M, et al. The risk of allergic reaction to SARS-CoV-2 vaccines and recommended evaluation and management: a systematic review, meta-analysis, GRADE assessment, and international consensus approach. J Allergy Clin Immunol Pract. 2021;9:3546-67. 34153517.

In suspected COVID-19, RT-PCR with nasal plus throat swabs has 97% sensitivity vs. nasopharyngeal swabs.

SOURCE CITATION: Tsang NN, So HC, Ng KY, et al. Diagnostic performance of different sampling approaches for SARS-CoV-2 RT-PCR testing: a systematic review and meta-analysis. Lancet Infect Dis. 2021. [Epub ahead of print.] 33857405.

Genomic surveillance to combat COVID-19: challenges and opportunities.

Although the development and increasingly widespread availability of effective and safe vaccines provides the greatest hope for the future recovery from the increasingly devastating COVID-19 pandemic, there are other preventive efforts that offer an immediate route to decreasing morbidity and mortality. Genomic surveillance is emerging as a vital necessity to achieve effective mitigation and containment. Since SARS-CoV-2 variants have already been detected, it is crucial to obtain reliable evidence about whether they are more contagious, virulent, or more resistant to the available COVID-19 vaccines well before they spread throughout the world. Genomic surveillance leverages applications of next-generation sequencing, creates the availability of whole genome data, and advances phylogenetic methods. These methods offer novel means to detect variants that are phenotypically or antigenically different. Genomic surveillance will facilitate greater early anticipation as well as initiation of effective strategies to mitigate and contain outbreaks of SARS-CoV-2 variants and other novel viruses.

COVID-19 control in the United States: the case for masking.

As of May 2021, the United States remains the world leader with 33 million of 165 million cases worldwide (20%) and 590,000 of 3.4 million deaths worldwide (17%) from COVID-19. Achieving herd immunity by disease spread and vaccination may result in 2 million to 4 million total US deaths. The future perfect of the vaccine should not be the enemy of the present good, which is masking. Masking, especially when combined with social distancing, crowd avoidance, frequent hand and face washing, increased testing capabilities, and contact tracing, is likely to prevent at least as many premature deaths as the widespread utilization of an effective and safe vaccine. Worldwide, masking is the oldest and simplest engineered control to prevent transmission of respiratory pathogens. Masking has been a cornerstone of infection control in hospitals, operating rooms, and clinics for more than a century. Unfortunately, since the epidemic began in the United States, masking has become politicized. All countries, but especially the United States, must adopt masking as an urgent necessity and a component of coordinated public health strategies to combat the COVID-19 pandemic. Any economic advantages of pandemic politics are short-lived and shortsighted in comparison with public health strategies of proven benefit that can prevent needless and mostly avoidable premature deaths from COVID-19. During the worst epidemic in more than 100 years, most Americans (75%) trust their health care providers. As competent and compassionate health care professionals, we recommend that effective strategies, especially masking, and not pandemic politics, should inform all rational clinical and public health decision-making.

Remdesivir for coronavirus 2019 (COVID-19): More promising but still unproven.

From December 2019 to May 22, 2020 the emerging and ever-increasing pandemic of coronavirus 19 (COVID-19) had no effective and safe treatment. Not surprisingly, remdesivir attracted worldwide attention. In a trial published online ahead of print, of 1063 patients, 541 were assigned at random to remdesivir and 522 to placebo. The primary prespecified endpoint was mean recovery time and patients assigned to remdesivir had a mean recovery time of 11 days versus 15 days for those assigned a random to placebo. (p < 0.001). With respect to mortality, the prespecfied secondary endpoint, 34/538 patients in remdesivir and 54/521 in placebo died after 28 days, yielding a possible 31% reduction that approached but did not achieve statistical significance (p = 0.059). The only other published trial of remdesivir randomized 237 patients in China. In that trial, 178 patients were assigned at random to remdesivir compared to 79 assigned to placebo. Those assigned at random to remdesivir experienced a possible but nonsignificant 23% faster time to clinical improvement of 21 days compared with 23 for those assigned to placebo [hazard ratio 1.23 [95% CI, 0·87-1.75)]. With respect to mortality there was no suggestion of any benefit. In fact, the mortality rate in those receiving remdesivir was 15% (22/150) compared with 13% (10/77) for those assigned to placebo. Ongoing randomized trials should be designed, conducted and analyzed to provide the necessary reliable data on mortality to resolve the remaining clinical uncertainties.