N-acetylcysteine as early Covid intervention may avoid excess inflammation

Aikaterini Nasi,^a,i Stephanie McArdle,^b Gustav Gaudernack,^c Gabriel Westman,^d Cornelis Melief,^e,f Johan Rockberg,^g Ramon Arens,^e Demetrios Kouretas,^h Jan Sjölin,^d and Sara Mangsbo^a,i,*

Abstract

During the current COVID-19 pandemic, a need for evaluation of already available drugs for treatment of the disease is crucial. Hereby, based on literature review from the current pandemic and previous outbreaks with corona viruses we analyze the impact of the virus infection on cell stress responses and redox balance. High levels of mortality are noticed in elderly individuals infected with SARS-CoV2 and during the previous SARS-CoV1 outbreak. Elderly individuals maintain a chronic low level of inflammation which is associated with oxidative stress and inflammatory cytokine production, a condition that increases the severity of viral infections in this population. Coronavirus infections can lead to alterations of redox balance in infected cells through modulation of NAD + biosynthesis, PARP function along with altering proteasome and mitochondrial function in the cell thereby leading to enhanced cell stress responses which further exacerbate inflammation. ROS production can increase IL-6 production and lipid peroxidation resulting in cell damage. Therefore, early treatment with anti-oxidants such as NAC during COVID-19 can be a way to bypass the excessive inflammation and cell damage that lead to severe infection, thus early NAC as intervention should be evaluated in a clinical trial setting.

Declaration of Competing Interest

The authors declare no conflict of interest.

Acknowledgement

The last author has received funding from Svenska Sällskapet för Medicinsk Forskning (SSMF) and the Knut and Alice Wallenberg (KAW) Foundation and SciLife laboratory COVID-19 call.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7301821/

Teachers union sues to halt Florida classroom restart during pandemic

A Florida teachers union sued the state on Monday in an effort to halt next month’s planned restart of classroom instruction, which it says poses an “imminent threat to the public health, safety and welfare” of its members, students and parents.

Citing the state’s position as a leading U.S. coronavirus hot spot, the Florida Education Association (FEA) argued in its lawsuit that in-class instruction violates the state constitution’s guarantee of a “safe” education for children.

The union’s complaint against Republican Florida Governor Ron DeSantis and other officials asks the state Circuit Court in Miami-Dade County for an emergency order halting classroom in-class instruction to avoid “irreparable harm.”

“The spread of COVID-19 that will result from the unsafe reopening of schools during the surge is not limited to students, teachers, school administrators, or school staff and will undoubtably spread to their families and communities,” the complaint said.

With new coronavirus infections having topped 10,000 per day for nearly a week, Florida has emerged as one of the country’s epicenters for the pandemic in recent weeks.

“The governor needs to accept the reality of the situation here in Florida, where the virus is surging out of control,” association President Fedrick Ingram said in a statement.

The suit also names Education Commissioner Richard Corcoran, who issued a July 6 order requiring local officials to “open brick and mortar schools at least five days per week” in August for families opting for in-class instruction, as opposed to remote instruction.

Corcoran replied that his order did not lay out any new requirements for schools to be open.

“It simply created new innovative options for families to have the CHOICE to decide what works best for the health and safety of their student and family,” he said in a statement.

The FEA, which has 140,000 members, is affiliated with both national teachers unions, the American Federation of Teachers and the National Education Association, both of which it said support the suit.

https://www.reuters.com/article/us-health-coronvirus-usa-florida/teachers-union-sues-to-halt-florida-classroom-restart-during-pandemic-idUSKCN24L2I3

CytoSorbents reports 58% revenue growth in Q2 preliminary results

CytoSorbents (NASDAQ:CTSO) reports preliminary 58% Y/Y increase in 2Q20 revenue to $9.8M, including product revenues of ~$9.5M. It compares to revenue estimate of $9.46M.

Product revenues has shown 61% improvement from $5.9M a year ago, and up 16% Q/Q.

The company generated ~$667K in U.S. hospital sales after receiving Emergency Use Authorization from FDA for use of CytoSorb in critically ill COVID-19 patients.

Preliminary blended product gross margins were ~70% against 76% a year ago, impacted by increased costs of ramped-up production in response to COVID-19 demand.

CytoSorbents expects REFRESH 2-AKI clinical trial to restart this quarter after completion of pending positive DSMB review and trial sites.

Cash balance stood at ~$35.1M, with cash burn of ~$2.3M for the half year ended Q2 2020.

Q2 actual results scheduled to be released on August 4.

https://seekingalpha.com/news/3592877-cytosorbents-reports-58-revenue-growth-in-q2-preliminary-results

Novartis Q2 Sandoz sales down 11% in reversal from Q1 forward purchasing

Novartis (NVS) Q2 results:

Revenues: $11,347M (-3.5%); Innovative Medicines: $9,188M (-1.5%); Sandoz: $2,159M (-11.4%).

The sales declined due to COVID-19 impacts, mainly from the reversal of Q1 forward purchasing and lower retail demand.

Net Income: $1,867M (-11.5%); EPS: $0.82 (-9.9%); non-GAAP Net Income: $3,108M (+0.4%); non-GAAP EPS: $1.36 (+1.5%).

CF Ops: $3,961M (+27.3%).

Top sellers: Cosentyx: $944M (+10%); Gilenya: $738M (-11%); Entresto: $580M (+38%); Tasigna: $480M (+3%); Lucentis: $401M (-25%); Promacta/Revolade: $422M (+21%); Tafinlar + Mekinist: $371M (+9%); Sandostatin: $341M (-15%); Jakavi: $310M (+9%); Gleevec/Glivec: $288M (-11%); Xolair: $289M (unch); Afinitor/Votubia: $266M (-34%); Ilaris: $200M (+21%); Exjade/Jadenu: $163M (-36%); Zolgensma: $205M; Kisqali: $159M (+43%); Votrient: $162M (-16%).

2020 Guidance: Net sales growth: mid- to high-single digit (unch); Innovative Medicines: grow mid single digit from mid to high-single digit; Sandoz: grow low-single digit (unch); Core operating income: to grow low double digit from high single to low double digit.

Key Innovation Milestones: Cosentyx approved in EU and US for treatment of active nr-axSpA.

Zolgensma IV conditionally approved in EU for SMA children up to 21kg

Entresto, Tabrecta, Mayzent, Enerzair and Atectura simultaneously approved in Japan.

The company resolved legacy legal matters, including the settlements related to FCPA and US speaker programs.

Previously: Novartis EPS beats by $0.03, misses on revenue (July 21)

https://seekingalpha.com/news/3592931-novartis-q2-sandoz-sales-down-11-triggered-reversal-from-q1-forward-purchasing

Japan trials app to help coronavirus patients recover at home

A smartphone app developed by medical software specialist Allm is being trialled in Japan to see if it can help patients with milder coronavirus symptoms recuperate at home, without tying up healthcare resources.

The app – called MySOS – provides “non-contact body monitoring”, harnessing artificial intelligence to measure vital signs such as oxygen levels in the blood (SpO2), respiration rate and blood pressure using a smartphone camera.

Based on this information, patients can then be connected to healthcare providers via two other Allm software modules – called LINE and TEAM – that have already been used during the pandemic to support people with mild COVID-19 symptoms.

The software packages provide a two-way conduit of medical information that can be used to keep patients out of hospital or other clinical facilities, alleviating the burden on the healthcare system and potentially also reducing transmission to other people.

It is estimated that four out of five people with COVID-19 recover from the disease without needing any special treatment, and either have mild symptoms or none at all. One in five develop breathing difficulties that may require hospital care.

Japan’s Agency for Medical Research and Development (AMED) will test the MySOS app with the help of Japanese drugmaker Eisai and Tokyo Medical and Dental University over the course of a one-year study, which will be carried out in Kanagawa Prefecture and Tokyo.

In a statement, Eisai said that the risk of another spike in COVID-19 cases means that it is important to establish a system that allows for the “arrangement of secure medical treatment at home.”

The trial will use an olfactory (smell) test developed by Eisai as one diagnostic criteria – loss of the sense of smell is emerging as a way to detect coronavirus infections – along with other commercially available antibody and antigen tests.

This study will apply widely used smartphone and [social networking service] technologies and add a function that allows for remote acquisition of various data that contribute to medical decision making…without requiring special knowledge or equipment from users, according to a summary of the trial.

The system will try to reduce anxiety in people with a positive diagnosis of COVID-19 but mild symptoms, to try to prevent them rushing to the emergency room, but will also include an alert system to detect if a patient has a sudden deterioration in health while at home.

A key objective of the study is to develop criteria to determine when medical treatment can be ended and patients can return to their normal lives.

Japan trials app to help coronavirus patients recover at home

HHS unveils new public coronavirus data system

The Trump administration has restored public access to coronavirus data reported by hospitals to the federal government, after an outcry over missing data and controversy over a change in the agency that collects it.

The information is now being published on the Department of Health and Human Services’s (HHS) site, HHS Protect, instead of the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network.

The change was necessary, officials said, because they believed the CDC’s system was too slow, and wasn’t able to keep up with the constantly changing information about the virus.

HHS Secretary Alex Azar echoed that complaint during a call with governors on Monday, according to a source familiar with the discussion, saying the existing CDC system was only providing data for half of the hospital systems around the country and could not be adapted quickly enough to respond to the pace of crisis.

The new system will collect more data from more hospitals. CDC’s reporting system only collected data from about 3,000 of the country’s roughly 6,200 hospitals, HHS officials said. The new system collects data from about 4,500 hospitals in only a few days. It took weeks under the CDC system, officials said.

“We’re showing you a data set that is more robust and has more coverage than anything we have published, historically, before,” HHS chief information officer Jose Arrieta told reporters Monday.

HHS last week instructed hospitals to change how they report certain coronavirus data to the government, bypassing the CDC and instead sending it to HHS directly. The new HHS database is run by a private contractor called TeleTracking, which was awarded a $10 million contract in April.

The move sparked an outcry from outside health groups that feared the CDC was being sidelined, and raised concerns about political interference.

HHS on Monday said there are multiple safeguards in place to prevent interference. For instance, all data is recorded and time stamped before it is accessible, and changes are tracked.

“This is a system designed to be above politics and manipulation. The public health professionals who work at HHS are solemnly devoted to the health and wellness of all of America and committed to empowering Americans with the same knowledge guiding the decision makers in the COVID-19 response,” the agency said in an FAQ document.

Arrieta said the raw data will be available to hospitals to use and incorporate into their own dashboards. Members of the public and third-party researchers will also have access to the raw data.

“We think that this level of transparency will not only help create and end develop some of the scientific minds of the future, but it creates maximum transparency for American citizens,” Arrieta said.

https://thehill.com/policy/healthcare/508200-hhs-unveils-new-public-coronavirus-data-system

Electrostatic Drone Could Disinfect Stadiums In Three Hours

A Pittsburgh-area company says they have developed a drone that could sanitize entire stadiums in three hours.

The drone utilizes electrostatic technology to quickly and safely sanitize large areas, bringing hope that major sporting events, concerts, and large events could become a reality in the era of COVID-19.

Aeras Fog Company is a Wexford based business created by entrepreneurs Justin Melanson, Eric Lloyd, and Nick Brucker.

“If this wasn’t going to be something that’s going away in a short period of time, there needs to be a solution to get people back to the things they enjoy doing,” said Nick Brucker, the co-founder of Aeras Fog Company.

The company says their drones charge disinfectant as it passes through the system’s nozzles, causing it to be attracted to ground surfaces and thoroughly coat them.

The disinfected areas also includes underneath seats, railing, and arm rests.

“There’s no room for human error where somebody might miss something. This drone doesn’t miss anything,” said Aeras Fog Company co-founder Justin Melanson.

Aeras says they can spray up to 20 acres per hour, and the area can be safely occupied three minutes after it is sprayed.

The company recently tested the system on Pittsburgh’s Highmark Stadium.

“We’re really excited about the peace of mind this technology has the potential to provide,” co-founder Eric Lloyd said in a press release. “Everyone’s wondering when they’ll be able to attend a sporting event or live concert safely, or when it will be safe for children and staff to return to school. We believe that, by overcoming one of the major challenges associated with these activities, Aeras will help bring us all closer to sharing these experiences again.”

The company says they expect to have all certifications in place by this fall, and the drones could be used in any large outdoor or indoor spaces such as stadiums, Nascar venues, hockey rinks, playgrounds, and even schools.

“If we could save a life, 10, 20, 100 lives, this could be a very good thing for everybody right now,” said Melanson.

Pittsburgh-Area Company Develops Electrostatic Drone That Could Disinfect Stadiums In Three Hours