Tag: covid prophylaxis

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Nasal Spray Containing Azelastine Reduces Risk of SARS-CoV-2 Infection by Two-thirds

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A research team at Saarland University has demonstrated in a clinical study that a widely used anti-allergy nasal spray containing the active ingredient azelastine can significantly reduce the risk of infection with the SARS-CoV-2 virus. The results of the placebo-controlled trial involving 450 healthy participants have now been published in JAMA Internal Medicine.

The trial, led by Professor Robert Bals, Director of the Department of Internal Medicine V at Saarland University Medical Center and Professor of Internal Medicine at Saarland University, divided the 450 participants into two groups. The treatment group of 227 individuals used an azelastine nasal spray three times a day over a 56-day period. During that same period, the 223 participants in the control group used a placebo spray three times a day. Robert Bals summarised the key finding as follows: ‘During the observation period, 2.2% of the participants in the azelastine group became infected with SARS-CoV-2; in the placebo group, it was 6.7%—three times as many.’ All infections were confirmed by PCR testing.

In addition to showing a marked reduction in coronavirus infections, the azelastine group also displayed fewer symptomatic SARS-CoV-2 infections, a lower overall number of confirmed respiratory infections, and, unexpectedly, a reduced incidence of rhinovirus infections, another major cause of respiratory illness. In the treatment group, 1.8% developed a rhinovirus infection, compared to 6.3% in the placebo group—a proportion similar to that seen for SARS-CoV-2.

Azelastine nasal spray has been available for decades as an over-the-counter treatment for hay fever. Previous in vitro studies on azelastine had already suggested antiviral effects against SARS-CoV-2 and other respiratory viruses. ‘This clinical trial is the first to demonstrate a protective effect in a real-world setting,’ says Professor Bals.

For Robert Bals, the results suggest practical applications: ‘Azelastine nasal spray could provide an additional easily accessible prophylactic to complement existing protective measures, especially for vulnerable groups, during periods of high infection rates, or before travelling.’ But Professor Bals also stressed the importance of further research: ‘Our results highlight the need for larger, multicentre trials to continue exploring the use of azelastine nasal sprays as an on-demand preventive treatment, and to examine its potential effectiveness against other respiratory pathogens.’

Besides Professor Bals, the randomised, double-blind phase 2 study ‘CONTAIN’ also involved the Institute of Clinical Pharmacy (Professor Thorsten Lehr, Dr. Dominik Selzer), the Institute of Virology (Professor Sigrun Smola), and the Saarbrücken-based pharmaceutical company URSAPHARM Arzneimittel GmbH, which sponsored the study and manufactured the investigational product. The Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) contributed through the research groups of Professor Smola and Professor Bals. The project serves as an excellent example of successful collaboration between academic research, industry partners and public health initiatives in the Saarland region.

Source: Saarland University

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After COVID, Experts Advise Against Universal Masking in Healthcare

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While masking was a critical preventative measure to protect healthcare workers, patients and visitors during the COVID pandemic, infectious disease researchers argue against masking, saying that that as the pandemic dies down, the routine use of masking should be reconsidered. Previous policies over healthcare masking use against SARS-CoV-2 transmission were formulated against a background which assumed no population immunity and no countermeasures.

In editorial published in Annals of Internal Medicine, the authors argue for the discontinuation of universal COVID masking in healthcare settings as infection rates and mortality have fallen and access to testing and therapeutics is widespread, as is immunity. Universal masking is therefore no longer of benefit and its own drawbacks, such as facial irritation and hindering communication, are more of a hinderance.

In addition to difficulties faced by speakers of different languages as well as the hard of hearing, masks have a number of detrimental effects for communication. “The increase in listening effort required when masks are used in clinical encounters is associated with increased cognitive load for patients and clinicians,” the authors wrote. In addition to making clinicians’ jobs harder, they also impact the all-important clinician–patient relationship, as face masks “obscure facial expression; contribute to feelings of isolation; and negatively impact human connection, trust, and perception of empathy.”

Healthcare workers should instead adopt an approach for SARS-CoV-2 similar to that of any other endemic respiratory disease. Drawing on the experience of the COVID pandemic, they suggest a more flexible, responsive approach to masking policies. In response to future epidemics or localised outbreaks “may justify more widespread or targeted masking policies, respectively, as part of a bundled response. High-quality epidemiologic data with frequent updates and regular reevaluation are needed to inform scale-up or scale-down decisions.”

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Antibody COVID Prophylactic Cocktail Performs Well in Trials

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A COVID prophylactic cocktail of long-acting antibodies cut the risk of developing symptomatic disease in a high-risk unvaccinated patient population, AstraZeneca announced on Friday.

Initial phase III trial data showed that AZD7442 (tixagevimab and cilgavimab) as pre-exposure prophylaxis significantly reduced the risk of developing COVID symptoms by 77% versus placebo, meeting the trial’s primary endpoint.
AstraZeneca further noted there were no cases of severe COVID or COVID-related deaths in the intervention group, while there were three cases of severe COVID and two deaths in the placebo group.

No safety concerns were noted by the manufacturer, as the treatment was well-tolerated and adverse events were balanced between groups.

A key feature of the trial was that 75% of participants had comorbidities, including being “at risk of an inadequate response to active [immunisation],” such as older adults and those with immunosuppressive disease or on immunosuppressive medication.

“With these exciting results, AZD7442 could be an important tool in our arsenal to help people who may need more than a vaccine to return to their normal lives,” the trial’s principal investigator, Myron Levin, MD, of the University of Colorado School of Medicine, said in a statement.

AZD7442 was derived from the B cells of convalescent patients. PROVENT was a phase III randomised trial conducted in the US and Europe. Participants were 5197 adults “who would benefit from prevention” with the long-acting antibody, were unvaccinated at the time of enrollment, and tested negative for SARS-CoV-2.
Participants were randomised 2:1 to receive a single 300 mg dose of AZD7442 or placebo. AstraZeneca noted that 43% of participants were ages 60 and older. The company noted that the drug is active in lab studies against emerging strains, including the Delta variant.

Patients were followed for 183 days, though subjects are slated to be followed for 15 months, AstraZeneca said. Data will be submitted for peer-reviewed publication while the company seeks approval for AZD7442.

Source: MedPage Today