Coronavirus News Roundup: Guidance Allows Pharmacist Testing, Acceleration of Treatments, CDC Reports

This week witnessed surges in studies, clinical trials, possible treatment candidates, and FDA authorization of treatments for the novel coronavirus disease 2019 (COVID). As confirmed case numbers approach their peak in the United States, the health system response to the virus has been on high alert. 

Here’s a roundup of the latest coronavirus-related news:

ASHP Urges Action to Address Shortages of Supportive Ventilation Medications

Last week, in a letter to Vice President Pence, ASHP Chief Executive Officer Paul W. Abramowitz, PharmD, requested that the Administration initiate significant increases in manufacturing of supportive medications critical to ventilating and treating patients with severe COVID-19.

In the letter, Abramowitz explained that, although ASHP is grateful for the action the Administration has taken to provide hospitals with necessary personal protective equipment and ventilators, they “will be rendered useless without an adequate supply of the medications…that must administered concomitantly with mechanical ventilation in critically ill patients…to ensure the successful use of this life-saving supportive care.”

CDC: COVID-19 Hospitalizations Highest Among Older Adults, Those With Underlying Conditions

The CDC has provided the updated reports of population-based COVID-19-associated hospitalizations between March 1-28, and clinical data on admitted patients between March 1-30, in 99 counties and 14 states.

The study, which was published in the CDC’s Morbidity and Mortality Weekly Report, stresses the importance of continuing to follow social distancing, respiratory hygiene, and face covering strategies in order to flatten the curve.

The CDC report contends that hospitalization rates increase with age and are highest among older adults. Additionally, the majority of those hospitalized for COVID-19 infection have at least 1 underlying condition.

Children May Not Always Have Fever, Cough with COVID-19 Infection

Children with COVID-19 may not develop a fever or cough as often as adults with the virus, according to a new preliminary findings published in the CDC’s Morbidity and Mortality Weekly Report.

Previous data have suggested that pediatric COVID-19 cases are typically less severe than cases seen in adults, and that children may present with different symptoms.

Pharmacy Groups Praise HHS Guidance Allowing Pharmacists to Provide COVID-19 Testing

A coalition of national and local pharmacy organizations is praising the Department of Health and Human Services’ (HHS) decision to allow licensed pharmacists to order and administer COVID-19 tests during the new coronavirus disease pandemic.

“Pharmacists, in partnership with other healthcare providers, are well positioned to aid COVID-19 testing expansion. Pharmacists are trusted healthcare professionals with established relationships with their patients,” HHS said in an April 8 guidance. "The vast majority of Americans live close to a retail or independent community-based pharmacy. That proximity reduces travel to testing locations, which is an important mitigation measure.”

“The accessibility and distribution of retail and independent community-based pharmacies make pharmacists the first point of contact with a healthcare professional for many Americans,” said HHS Assistant Secretary for Health Brett P. Giroir, MD, in a press release. “This will further expand testing for Americans, particularly our healthcare workers and first responders who are working around the clock to provide care, compassion and safety to others.”

FDA Issues Warning for Chlorine Dioxide Products Claiming to Treat COVID-19

Officials with the FDA issued a warning letter to a company marketing fraudulent and dangerous chlorine dioxide products for the prevention and treatment of COVID-19, according to a press release.

The product, known as “Miracle Mineral Solution,” is being sold online and marketed as a medical treatment, despite having no scientific evidence supporting the safety and efficacy of its use. The FDA has previously issued a warning to consumers urging them to stop drinking such chlorine dioxide products after receiving reports of the products making people sick.

FDA Approves First Generic of Albuterol Sulfate Inhaler

The FDA has approved the first generic version of a commonly used albuterol sulfate inhaler. Albuterol sulfate (Proventil HFA) metered dose inhaler, 90 mcg/inhalation, is indicated to treat or prevent bronchospasms for patients 4 years of age and older with reversible obstructive airway disease and/or exercise-induced bronchospasm, according to a press release.

The announcement follows recent reports across the country identifying shortages of albuterol inhalers in hospitals due to the COVID-19 pandemic. Because of COVID-19 there has been increased allocation of albuterol inhalers for patients with or suspected to have COVID-19 infection due to concerns that nebulizers may help spread the virus in the air in hospitals.

Study Investigates COVID-19 Mortality, Early Indicators of Poor Prognosis

A new study of data from China found that the majority of fatality cases associated with the COVID-19 were men aged over 50 years old with noncommunicable chronic diseases.

As COVID-19 continues to spread, and the death toll rises, experts aim to better understand the clinical features of the disease and factors for increased mortality.

Increasing evidence has shown that the virus “induces excessive and aberrant non-effective host immune responses associated with severe lung injury,” the study’s authors wrote. Higher rates of acute respiratory distress syndrome (ARDS) have been observed in older patients with comorbidities. In this study, the authors aimed to identify the clinical characteristics that may serve as markers for poor prognosis at an early stage.

Study: Actual Number of COVID-19 Cases Vastly Underestimated

Although the estimation of reported confirmed COVID-19 cases has hit almost 1.4 million at the time of this publication, the actual number of cases may have already reached several tens of millions, according to a new study published in The Lancet Infectious Diseases.

Because of varying delays and insufficiencies in testing across different countries, reported numbers worldwide may not accurately reflect the amount of actual COVID-19 infections. Assessing the severity of the pandemic is crucial to identifying appropriate mitigation strategies.

“However, crude case fatality ratios obtained by dividing the number of deaths by the number of cases can be misleading,” the authors wrote in the study. This is because it can take a couple of weeks between a person developing symptoms, the case subsequently being detected and reported, and observation of the final outcome.

Incyte, Novartis Plan Phase 3 Trial for Ruxolitinib in COVID-19

Novartis and Incyte are planning to initiate a new clinical trial to evaluate ruxolitinib (Jakafi) in certain patients with COVID-19, according to a press release.

The phase 3 clinical trial will investigate the use of ruxolitinib for the treatment of a type of severe immune overreaction called cytokine storm that can result from coronavirus infection and can lead to life-threatening respiratory complications. The collaborative study will be sponsored by Incyte in the United States and Novartis outside of the United States.

FDA to Accelerate Development of Blood-Related Therapies for COVID-19

The FDA announced their commitment to expediting the development and accessibility of convalescent plasma and hyperimmune globulin as COVID-19 therapies, the agency said in a news release on Saturday.

Convalescent plasma and hyperimmune globulin are antibody-rich blood products made from blood donated by individuals who have recovered from SARS-CoV-2, the virus that causes COVID-19.

University of Pittsburgh Announces Promising Vaccine Candidate

Scientists from the University of Pittsburgh School of Medicine recently announced their vaccine candidate against SARS-CoV-2, the virus that causes the novel coronavirus.

University of Pittsburgh School of Medicine also implemented a drug delivery method to increase potency, called a microneedle array, through a fingertip-sized patch of 400 tiny needles that transfer the spike protein pieces into the skin in order to maximize the immune response.

Communicating with Patients in the Time of COVID-19

The COVID-19 outbreak has affected every part of our health care system. Pharmacies, just as expected, have showed up in meaningful ways to support their communities. We’re seeing independent community pharmacies compound hand sanitizer and donate the product to medical facilities, local emergency medical services, fire and police departments. Many pharmacies are operating closed-door stores and delivering prescriptions right to their patients’ homes. Some are making care packages and donating them to the elderly and the immunocompromised. We are so thankful for all the pharmacists out there who are working on the frontlines right now.