Category: Covid-19

WAVERLY, N.Y. (WETM) The Tioga County Public Health Department will be offering free rapid COVID-19 testing in Waverly from Oct. 21-23 at the Waverly Village Hall on Ithaca Street.

Testing will be available at the following times:

Participants must pre-register at covid19.tiogacountyny.com, visiting the Tioga County Public Health Facebook page, or by calling at 607-687-8600.

Those being tested do not have to be a resident of Tioga County for this testing location.

Masks are to be worn inside the building and visitors should follow the direction of staff before entering.

Those with general COVID-19 questions may call the Tioga County Public Health Department at 607-687-8623.

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COVID-19 rapid testing available in Waverly - WETM - MyTwinTiers.com

We were already worried our phones were being monitored. But we could easily switch out SIM cards or use the ubiquitous pay phones at local grocery stores. The surveillance system back then still relied on people following other people. And even trained state security agents can lose track of people. Under this relatively lax regime, Jakes, the Time reporter, was able to contact a trauma surgeon from Beijings 301 Hospital, Jiang Yanyong, who revealed the true extent and scope of the outbreak and the astonishing scale of the cover-up, including patients being wheeled out of hospitals via back exits as WHO inspectors were entering the front. Jakes had gotten lucky when Jiangs daughter reached out to her and said her brother wanted to write an open letter on what he had seen. Jiang told Jakes that the Chinese government could not be relied on to tell the truth about the number of infected, sick, and dying.

The mayor of Beijing and the minister of health would both resign after Jakess stories, the only instance I can recall of high-level Chinese government ministers resigning due to a scoop.

Because of changes in China and the United States, reporting on the COVID-19 outbreak is more challenging. For a few weeks in January and February, journalists in Wuhan, some of them ordinary citizens, told the world what was happening at great personal risk. Then, in March, Chen Qiushi, one citizen journalist who wrote critical stories of the Chinese governments initial handling of the outbreak, simply vanished. Chinese journalists and scientists have since been wary of speaking out. And very few Westerners have managed to report from Wuhan. We havent definitively learned much more about the origins of the disease since those first reports last year: Who was the index patient? Where does the host species reside? What species was the intermediary, if there was one? In other words, the answers to the journalistic questions who, what, when, and where.

The Communist Partys security services have become so ruthless at shutting down dissent that today, a whistleblower like Jiang might hold back. The willingness to enlarge the circle of pain has made a difference, Pomfret told me. Talk to a journalist now, and that could mean ruining your childrens life, your grandchildrens. That has had a stultifying effect.

These extreme measures are in part due to disease outbreaks being particularly embarrassing for governments that tout prosperity and law and order as primary claims to legitimacy.

The surveillance situation is far more extreme, as well. China is practically a cashless society, where transactions are made via smartphone. And buying a new SIM card requires an official, state-issued identification card that is duly noted and logged. A system that tracks you by your smartphone can always find you via your smartphone. In 2003, Jakes talked with Jiang on a pay phone before going to meet him on a subway; that sort of scenario is improbable now.

More:

We May Never Know the Full Story of COVID-19 - The Atlantic

He was 41 when he died. And though he faced substance use disorder throughout his adult life, David was sober nearly the entire year leading up to the pandemic. When I saw him over dinner and donuts last November on a visit to Los Angeles, he was crushing life. I was proud of him. My handsome, charming big brother finally had it together. (Of course, even when he didn't have it "together," he was still my biggest champion.) David was thriving as a personal trainer at a gym. He loved being a dad and absolutely adored his little girl. Although they weren't living together at the time, he would text me most days with photos and videos of my niece. The last text he ever sent me on March 13 was a paraphrase of a quote he'd heard by myth scholar Joseph Campbell: "When you live a life for someone other than yourself, you are living a hero's journey," my brother wrote.

We worried about him. David plus free time was historically a recipe for disaster. I should have checked in. Aside from an email he sent me on March 17, congratulating me for a new article I wrote that week, I hadn't heard from David. The updates about my niece stopped. I should have known something was wrong.

On the phone with our father an hour or so before we learned of my brother's death, our dad said to me, "I'm worried about David. I don't know what kind of trouble he's going to get into now that he's not working and can't see his daughter. I think he's been sleeping all day." He sounded worried. David wasn't returning his calls that day. That night, I received a Facebook message from David's landlord asking me to give him a call. Thinking, hoping that David owed rent money, I sent his number to our father. My dad called me back shortly after speaking with the landlord, with a message he had long dreaded delivering: "David passed away."

Yet, when history books tally Covid-19's tragedies, David is likely to be left off the official count. Instead, he'll be sectioned off as part of the opioid crisis. In reality, these crises are inextricably connected. President Donald Trump may not have created either, but his attacks on health care and his disregard for science exacerbates these dual crises. In the middle of a pandemic and an economic downturn, the President shamelessly continues his crusade against health care, science, compassion and kindness: some of the most powerful tools we have to treat Americans and society at large.

If he gets his way, the Supreme Court will soon have a sixth vote that could strike down all of the Affordable Care Act and permanently end Obamacare for roughly 20 million people, a devastating scenario for Americans with substance use disorder who rely on Medicaid.

The expansion of Medicare and Medicaid through the Affordable Care Act meant significantly more people with substance use disorder had access to insurance. As with other pre-existing conditions, substance use disorder could no longer be a reason for an insurance company to deny someone coverage.

A compassionate leader would acknowledge the pain and struggles of people impacted by substance use disorder. Trump made it a cruel and factless punch against his opponent.

It is entirely possible my brother would have died regardless of who was president, pandemic or no pandemic. It's also probable that no matter how hard he worked to fight his disease, forces outside his control mixed with his medical condition and created a tragedy. I will never know exactly what happened in the final week of my brother's life. Nor does it matter. He is never coming back. But while it is too late to save my brother, there are countless people out there who can still be saved.

Through kindness, compassion, and modern medicine, we can stop more senseless deaths and tragedies. But we need a president who will champion these values. We need a president who will treat our society with science, compassion, and kindness. When Americans cast their ballots this election, I hope they consider the many layers of loss during this moment. I hope they consider my brother.

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My brother didn't get Covid-19, but he was a victim of it anyway - CNN

One in four women are considering downshifting their careers or leaving the workforce entirely because of the impact of COVID-19, according to a new report.

As many as 2 million women are considering taking a leave of absence or leaving the workforce altogether, warns Women in the Workplace, the largest comprehensive study of the state of women in corporate America.

Many employees are exhausted and burned out. Women in particular have been negatively impacted, and three groups are facing distinct challenges: mothers, senior-level women, and Black women.

The report is published by management consultancy McKinsey & Company and the womens campaign group LeanIn.Org.

Here are five key findings.

1. COVID-19 could push many mothers out of the workforce

Mothers are significantly more likely than fathers to be thinking about downshifting their careers or leaving the workforce, with childcare responsibilities as a primary reason.

An Asian American woman and senior manager with two children aged one and five tells the study: There were times when I said to my husband, One of us is going to have to quit our job. And I remember thinking, How come Im the only one thinking about this, and my husband isnt? I dont think him leaving was ever in question.

Mothers are more likely than fathers to consider leaving work.

Image: McKinsey/Lean In

Mothers are also more than twice as likely as fathers to worry that theyll be judged more harshly at work because of their caregiving responsibilities.

2. Companies are at risk of losing women in leadership

One working mother - a Vice President with a three-year-old child - told the studys authors: I dont have a sliver of time without a meeting from 8am until 6pm every single day. Theres no buffer to get a glass of water, go to the bathroom, check on my child.

More senior-level women are burning out than men.

Image: McKinsey/Lean In

Senior-level women are significantly more likely than men at the same level to feel under pressure to work more and be always on. And they are 1.5 times more likely than senior-level men to think about downshifting their careers or leaving the workforce because of COVID-19. Almost three in four cite burnout as a main reason.

3. Black women are less likely to feel supported at work during COVID-19

Black women are more than twice as likely as women overall to say the death of a loved one has been one of their biggest challenges during the COVID-19 pandemic. Incidents of racial violence across the US are also exacting a heavy emotional toll.

But fewer than one in three Black women report that their manager has checked in on them in light of recent racial violence. And only about a third say their manager has fostered an inclusive culture on their team.

There was a real silence after George Floyd happened. And I felt like that silence ripped open a wound that I didnt realize had been so deep, one Black and Latina manager told the authors.

Black women are less likely to feel supported at work during COVID-19.

Image: McKinsey/Lean In

4. How companies can address the core challenges women are facing

Employers need to check whether productivity and performance expectations set before COVID-19 are still realistic, and help create work-life boundaries, says the report. For example, establishing set hours for meetings.

They should also raise awareness in the workplace about unconscious bias - such as challenging assumptions that a child playing in the background of a video call means less commitment to work.

Employees need to be aware of the full range of benefits available to them, such as mental health counselling. Companies should share more regular updates on the state of the business and key decisions that affect employees work and lives.

Black women are less likely to feel supported at work during COVID-19.

Image: McKinsey/Lean In

5. How companies can better support Black women

Make an explicit commitment to advancing and supporting Black women and communicate it to employees, along with a clear explanation of why its important.

Many employees dont realize that Black women are having a markedly worse experience at work, the authors say. If employees understand this, they will be more likely to champion the Black women in their organization.

Companies also need to foster a culture in which Black women are fully valued and included.

Employees dont always support or advocate for others with less power.

Image: McKinsey/Lean In

Economists have dubbed the impact COVID-19 is having on women in work as a shecession.

For example, in August 2020, womens labour supply was still 20% below the pre-recession levels of February 2020, whereas mens labour supply was only 9% lower.

The World Economic Forums Global Gender Gap Report 2020, published in December 2019, highlighted the growing urgency for action, with gender parity still at least 99.5 years away.

Through its Platform for Shaping the New Economy and Society, the Forums initiatives include Closing the Gender Gap Country Accelerators and Hardwiring Gender Parity into the Future of Work, a business commitment framework to ensure the new world of work is inclusive.

With COVID-19 threatening to set back decades of progress on gender equality, this work is more urgent than ever.

Read this article:

1 in 4 women could quit their jobs due to COVID-19, McKinsey and Lean In warn - World Economic Forum

Calumet County will host a free COVID-19 community testing site starting Thursday, the latest in a string of new testing sites opening in the Fox Valley in the last week.

The drive-through site at Christ the Rock Community Church will be operated by the Wisconsin National Guard. Anyone experiencing symptoms of the virus or who has been in contact with someone who is infected is eligible for a test.

Those symptoms can include fever, cough, difficulty breathing, sore throat, runny nose, nausea, vomiting, diarrhea, headache, chills, muscle aches or loss of taste or smell.

Like other Guard-run COVID-19 testing sites, it's highly recommended but not required that people register ahead of time at register.covidconnect.wi.gov.

RELATED:U.S. surgeon general announces creation of federal COVID-19 testing site at ThedaCare clinic in Neenah

RELATED:New community testing site for COVID-19 opens at Appleton North High School

RELATED:Need a COVID test? Here's how and where you can get one in the Appleton area

Public health officials recommend that if you've been exposed to COVID-19, you wait five to seven days before coming in for a test, as the virus may take time to reach levels that would be noticeable by the test.

The site, at W6254 U.S. 10/State 114 in Menasha, will be open at the following dates and times:

The Guard will not be testing on Nov. 26-28.

Children ages 5 and older can be tested at the site, though those under 18 must be accompanied by a guardian.

The church site is the third site in a week to open for the area, including another Wisconsin National Guard-run site at Appleton North High School and a surge site set up by the federal government at ThedaCare Physicians-Neenah. This comes after months in which Fox Valley residents had to drive to Oshkosh or Green Bay for community testing.

Contact reporter Madeline Heim at 920-996-7266 or mheim@gannett.com. Follow her on Twitter at @madeline_heim.

Read or Share this story: https://www.postcrescent.com/story/news/2020/10/20/fox-valley-covid-19-test-site-open-christ-rock-church/5990421002/

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COVID-19 testing site will open at Christ the Rock Community Church - Post-Crescent

The COVID-19 pandemic has not only disrupted the social and economic realities of our communities, but also undermined some of the basic infrastructure we depend on. Our water infrastructure has been at the heart of this realization; its importance to health, hygiene, and safety has never been more obvious, yet millions of disadvantaged and vulnerable households still lack reliable and affordable access to water. Meanwhile, climate change has fueled extreme droughts, fires, and floods that have disrupted or destroyed this essential infrastructure. COVID-19 has exposed the continued neglect of our water infrastructure, magnifying long-standing social and environmental stressors as well as economic inequities.

State and local leaders manage most of our water needs, and many recognize the gravity of its challenges, despite facing massive fiscal constraints due to COVID-19. But federal leaders have not shown the same urgency. As Congress debates recovery strategies and stimulus efforts, water should be a bigger part of the conversation. Water can serve as a lever to achieve greater economic equity and access, environmental resilience, and technological innovation, among other benefits. Now is the time for Washington to elevate water as a core issue to drive a lasting recovery.

In a recent webinar hosted by the Stanford Woods Institute for the Environment (watch video at the end of this post), we discussed a set of practical solutions to address the gaps in water infrastructure and advance new innovations. Below are five key areas of intervention that federal leaders should be focusing on.

Our massive physical infrastructure needs (leaking pipes, overwhelmed sewers, and outdated treatment plants) often overshadow the needs of individual households. Water is ultimately an enabler for health and opportunity, but too many people cannot access or afford it. Lower-income communities of color frequently face some of the greatest water inequitiesincreased lead exposure and other harmful contaminants threaten drinking water quality in many of these communities, while storm and wastewater overflows inundate their streets and backyards. COVID-19s economic impacts have also highlighted persistent struggles to pay bills and avoid water shutoffs.

Federal policymakers need to focus more on people, not just projects. That means defining and measuring our water needs in light of our must vulnerable households. Fortunately, the Environmental Protection Agency (EPA) has started to revise its inadequate definition of water affordability to serve as guidance for utilities. But this should be just the beginningthe nation requires increased technical and financial support for customer assistance programs, including a comprehensive utility bill assistance program.

Climate change is inextricably linked to changes in the water cycle, such as too much or too little water, shifts in precipitation patterns, and untimely melts. Yet much of our national climate discussion focuses on mitigation (reducing greenhouse gases, improving energy efficiency) rather than adaptation (coping with sea level rise, handling extreme storms, etc.). While both are important, federal policymakers need to clearly acknowledge and invest in water-related adaptation efforts, especially since climate disasters tend to affect lower-income, disadvantaged communities the most.

When addressing wildfires, floods, or droughts, local governments are largely on their own. The Federal Emergency Management Agency (FEMA) and other federal agencies provide disaster relief, but utilities and other local leaders often struggle to accelerate proactive infrastructure investments that would improve their long-term resilience. Federal leaders must prioritize our water challenges in climate discussions, measure the fiscal impacts to states and localities, and build more financial and technical capacity at the state and local level for water-related adaptation. For example, establishing clearer federal regulations to govern private sector environmental, social, and governance (ESG) investmentincluding ways to collaborate with public sector entities such as local water utilitiescould get more projects done and help more communities.

There are more than 50,000 water utilities scattered across the country, making it hard to consistently and comprehensively govern (let alone define) our most pressing water infrastructure needs. Many utilities use antiquated business models that assume resource abundance and steady water sales. Meanwhile, federal agencies such as the EPA operate in the same bureaucratic siloes and oversee the same regulations they did decades ago. These outdated business practices, rigid laws, and fragmented governance structures impair the maintenance of our existing infrastructure and investment in new and innovative solutions.

Federal policymakers need to break down these siloes in order to better manage our national water needs and support a forward-looking governance model centered around the One Water concept. This concept involves looking at our drinking water, wastewater, and stormwater needs collectively, particularly when developing plans and launching investments.

To promote more collaborative governance across and within utilities, federal leaders should provide more guidance on the process for setting water rates so as to guarantee access for all households. Second, they should introduce new financial tools (such as a Public Benefits Charge) to enable more integrated resource management. Finally, leaders should implement new regulatory measures (such as water diversification portfolio standards) to better assess and support the financial standing of all utilities.

Our 21st century water infrastructure must address our 21st century environmental, economic, and health challenges. Federal leaders can embrace this shift in two ways.

First, there needs to be a transition to a hybrid infrastructure model that promotes a combination of gray/green and centralized/decentralized infrastructure improvements. Rather than supporting large, centralized treatment facilities and other traditional gray infrastructure (which can be costly to maintain and susceptible to climate risks), federal leaders need to look toward nature, floodplains, and other green infrastructure for more flexibility and environmental resilience. Doing so can help us recover and reuse every drop of water in our system, create operational redundancies through more distributed systems, and lead to many other environmental and community benefits. Federal leaders can promote these new designs through new financial incentives and pathwaysincluding loans, grants, and tax creditsthat encourage local experimentation.

Second, federal leaders need to embrace the digital transition in our water systems. The COVID-19 pandemic has disrupted our standard operating procedures and highlighted the importance of digital solutions, including advanced metering infrastructure and leak-detection analytics that help utilities prevent resource loss and maintain affordable, dependable service. Federal leaders should revisit regulations that govern federally owned infrastructure systems and federally funded projects to find room for data-driven solutions. For instance, Forecast-informed Reservoir Operations can help avoid dam failures, and revisions to the U.S. Army Corps of Engineers benefit-cost analysis can better evaluate water resources projects.

Improving the nations physical infrastructure depends on a skilled workforce to construct, operate, and maintain our facilities, but federal policymakers have overlooked these needs for decades. Many of the operators, engineers, and technicians who keep our water clean and essential services online are reaching the ends of their careers and frequently lack visibility, resulting in a diminished pipeline of talent. Meanwhile, millions of workers have lost their jobs during the pandemic, and there are mounting struggles to connect the unemployed to stable, well-paying careers. This gap in hiring, training, and retention comes even as water jobsmany of which are in the skilled tradesoffer competitive pay and the opportunity to develop valuable, transferrable work experience.

The COVID-19 recovery gives us a chance to not only rebuild and renew our infrastructure, but to connect more and different types of workers to water careers. Establishing a new, 21st century federal infrastructure workforce program aimed at providing flexible learning and career opportunities in the skilled tradesincluding watercan help disadvantaged and disconnected workers earn higher pay, learn more skills, and seize enduring opportunities. Expanded apprenticeships and work-based learning programs can prepare a new generation of talent while retraining and assisting other workers in water careers.

Together, these five areas of intervention reveal a national need to focus on future water priorities, not just prevailing trends. Water remains an essential service to all households and industries, but we cant keep taking it for granted; federal leaders need to intentionally elevate it as an economic and environmental priority. Proactive federal investment in new types of projects and people-centered strategies can support climate resilience, affordable access, and equitable growth. The COVID-19 pandemic has highlighted waters foundational role and the cracks in our existing systemnow its time to strengthen our commitment to water solutions that can support us for years to come.

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The hidden role of water infrastructure in driving a COVID-19 recovery - Brookings Institution

Travis Commissioners expected to hear details of COVID-19 local resurgence  KEYE TV CBS Austin

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Travis Commissioners expected to hear details of COVID-19 local resurgence - KEYE TV CBS Austin

(Clarinda) -- Page County Public Health officials are managing the overlap between COVID-19 and the start of flu season.

During the Page County Board of Supervisors meeting Tuesday, Public Health Administrator Jessica Erdman told the board that her office is managing the county's first two cases of co-infection, where an individual has influenza and COVID-19 at the same time.

"They have influenza and COVID-19," said Erdman. "That's new territory to us. We don't really know how that's going to pan out. We do know one of the people is very ill. So we are just keeping an eye on that to see what is going to come from that."

Additionally, Erdman says she is keeping her eye out for any cases of re-infection of COVID-19 in the county. Currently, she says the CDC says individuals remain immune from contracting COVID-19 a second time for 90 days.

"There were some studies done that came out a couple weeks ago about the possibility of re-infection before those 90 days are up," said Erdman. "The CDC has said that people have an immunity for 90 days after catching COVID-19. Now, there's a possibility that that could be false. There's been two studies that have been done of two positive cases that did come back positive again before their 90 days was up. That is nationwide."

Erdman says her office continues to work with the schools in Page County to manage cases and close contacts.

"We're working really closely with the schools," said Erdman. "We have a good amount of kids out for quarantine. That does not mean that they are positive. That means that they've been in close contact. We are waiting for some results of some of those kiddos."

The latest COVID-19 numbers from Page County and other southwest Iowa counties can be found on our daily COVID-19 tracker page

At KMA, we attempt to be accurate in our reporting. If you see a typo or mistake in a story, please contact us by emailing kmaradio@kmaland.com.

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Page County reports 2 cases of co-infection with COVID-19, influenza - KMAland

WATCH ABOVE: Governor JB Pritzker announces additional COVID-19 mitigation measures in Chicagos west and south suburbs Tuesday

CHICAGO Governor JB Pritzker said additional COVID-19 mitigation measures will be put in place in DuPage, Kane, Kankakee and Will counties this week after two suburban regions hit the State of Illinois COVID-19 test failsafe level Tuesday.

According to the Illinois Department of Public Health, both the West Suburban and South Suburban regions established in the Restore Illinois plan hit its COVID-19 failsafe level of three days with a 7-day test positivity rate above 8% Tuesday.

Starting Friday, new restrictions will be put in place DuPage, Kane, Kankakee and Will counties, including limits on gatherings to 25 people or 25 percent of room capacity, no indoor service at bars and restaurants, and all outdoor service must end at 11 p.m.

A complete listing of restrictions is available here

The measures are the same as those put in place in the states Southern Region Monday, and also remain in effect across northwest Illinois. Pritzker cited a spillover effect from neighboring states as partly to blame for the rise in cases in Illinois.

As colder weather approaches and flu season is upon us were going to see the rippling effect of these current unfortunate trends, Pritzker said. There is no easy fix for the effects of this virus on our economy and our public health.

Both regions initially passed the 8% level on October 15, while data released Tuesday shows a third day above the limit with rates of 9% in the West Suburban Region and 8.6% in the South Suburban Region as of Saturday.

The South Suburban region was previously subject to additional restrictions on August 26, but returned to Phase 4 of the states reopening plan on September 18.

Pritzker said previously that experts predictions of a surge in COVID-19 cases as temperatures drop and people move inside appears to be coming true and a new wave could be upon us.

Positivity rates in the suburban regions had been stable but began to rise over the past two weeks, while every other region has seen an increase as well. The North Suburban Region outside Chicago reached 7.5% as of Tuesday, while Cook County outside Chicago reported a rate of 7.1%.

Additional restrictions will remain in place until the rolling 7-day positivity rate drops below 6.5 percent for three days, and more stringent measures could be put in place if it remains above 8.5 percent after 14 days.

Advocate Sherman Hospital Interim Chief Medical Officer Dr. Justin Macariola-Coad said they are seeing an increase in hospitalizations across the hospital system.

Across our communities in Kane and the surrounding counties, we are seeing the start of what is most likely the second wave, Macariola-Coad said. Wisconsin is already surging and northern Illinois is likely next.

While Macariola-Coad said many are experiencing pandemic fatigue, he called on residents to follow the same basic health protocols experts have been stressing for months: observing social distancing, wearing face coverings and washing hands.

Governor Pritzker is returning to daily COVID-19 briefings as Illinois sees a resurgence in cases, and is expected to speak at 2:30 p.m. Tuesday.

Statewide, the IDPH reported 3,714 new COVID-19 cases and 41 coronavirus-related deaths Tuesday. The statewide positivity rate from October 13-19 rose slightly to 5.5%, near levels last seen in early June, although the weekly testing average has more than tripled since then according to data compiled by WGN-TV.

Data shows the 7-day average of cases in Illinois has risen from around 2,000 a day on October 6 to more than 3,700 as of Tuesday, while testing rose less sharply from around 58,000 to more than 67,000. The 7-day average of deaths has been rising over the past two weeks as well, from around 28 to 36 a day.

While the number of patients hospitalized with COVID-19 is beginning to rise statewide, the availability of ventilators and intensive care beds remains within state guidelines. According to the IDPH, 2,261 patients were hospitalized with COVID-19 as of Monday night, including 489 in intensive care and 195 on ventilators.

Several other regions reported 7-day positivity rates above 7% as of Tuesday, including Region 3 (7.5%), Region 4 (7.4%), Region 6 (7.6%), Additional restrictions remain in effect in the northwest Illinois region, which reported a 7-day positivity rate of 11.8% Tuesday.

The City of Chicago added Colorado, Delaware, Ohio, Texas and West Virginia to its emergency travel order requiring anyone arriving from those states to self-quarantine for 14 days Tuesday. Neighboring Indiana and Wisconsin remain on the list as well.

Mayor Lori Lightfoot said Monday some coronavirus restrictions could return in Chicago if the number of COVID-19 cases in the city continue to rise. Health officials said cases have risen by more than 50% over the past two weeks, increasing at a rate last seen in March and April.

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New COVID-19 restrictions coming to DuPage, Kane, Kankakee and Will counties after tests hit failsafe level - WGN TV Chicago

Patients get tested for COVID-19 in India, one of 30 countries that took part in the Solidarity trial.

By Kai KupferschmidtOct. 16, 2020 , 3:45 AM

Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

One of the worlds biggest trials of COVID-19 therapies released its long-awaited interim results yesterdayand theyre a letdown. None of the four treatments in the Solidarity trial, which enrolled more than 11,000 patients in 400 hospitals around the globe, increased survivalnot even the much-touted antiviral drug remdesivir. Scientists at the World Health Organization (WHO) released the dataas a preprint on medRxivlast night, ahead of its planned publication in The New England Journal of Medicine.

Yet scientists praised the unprecedented study itself and the fact that it helped bring clarity about four existing, repurposed treatments that each held some promise against COVID-19. Its disappointing that none of the four have come out and shown a difference in mortality, but it does show why you need big trials, says Jeremy Farrar, director of the Wellcome Trust. We would love to have a drug that works, but its better to know if a drug works or not than not to know and continue to use it, says WHOs chief scientist, Soumya Swaminathan.

The prospects of two of the four treatmentsthe malaria drug hydroxychloroquine and the HIV drug combination ritonavir/lopinavirhad faded after another large study, the United Kingdoms Recovery trial,showed they did not increase survivalin June. After analyzing that study and its own data up until then, WHO decided to drop both from the study.

There was still hope for remdesivir and for interferon-beta, which had initially been given in combination with ritonavir/lopinavir but was tested as a standalone drug after the Recovery data came out. But neither of those treatments lowered mortality or delayed the moment patients needed ventilation to help them breathe. The results in these two treatment arms are likely to be the most scrutinized.

Remdesivir, which attacks a specific enzyme in several RNA viruses and was previously tested against Ebola, was initially seen as a promising candidate. In a U.S. trial with more than 1000 COVID-19 patientspublished last week, those who received remdesivir had a shorter recovery time than patients in the control group, but there was no significant difference in mortality. Two smaller trials found few significant benefits. Remdesivir received an emergency use authorization from the U.S. Food and Drug Administration (FDA) in May for severe COVID-19 patients that was later expanded to include all patients.

But the Solidarity trial suggests the drug does little in severe cases. Of 2743 hospitalized patients who received the drug, 11% died, versus 11.2% in a control group of roughly the same size. The difference is so small it could have arisen by chance.

When the authors pooled Solidaritys data with those from the three other trials, they found a slight reduction in mortality that wasnt statistically significant either. This absolutely excludes the suggestion that remdesivir can prevent a substantial fraction of all deaths, the authors write. The confidence interval is comfortably compatible with prevention of a small fraction of all deaths but is also comfortably compatible with prevention of no deaths.

This trial doesnt help remdesivir, thats for sure, says Eric Topol, director of the Scripps Research Translational Institute. Its not a dead duck as much as hydroxychloroquine, but it certainly is not the hope that was initially signaled.

But the drugs manufacturer, Gilead Sciences, casts doubt on the study. The trial design prioritized broad access, resulting in significant heterogeneity in trial adoption, implementation, controls and patient populations, the companysays in a statement, and consequently, it is unclear if any conclusive findings can be drawn from the study results.

Gilead received the manuscript about Solidarity on 28 September, according to WHO. On 8 October, before the results became public, the company signed a$1 billion deal with the European Commissionfor a 6-month supply of the drug.

Solidaritys most disappointing results, however, are those for interferon-beta, Topol says. Mortality among the 2050 people who received that drug (either alone or in combination with lopinavir/ritonavir) was 11.9%, versus 10.5% in the control group. Prior studies have suggested interferon can only help if given early, however, and not once patients have been hospitalized. So I think thats still an open question, Topol says.

Treating COVID late is very difficult, Benjamin tenOever, a virologist at the Icahn School of Medicine at Mount Sinai, wrote in an email toScience. At this point in the disease the issue is more about inflammation and clotting, which is likely why these four drug regimens showed little value.

The silver lining may be that the trial itself, unprecedented in several ways, succeeded. Set up in a short time in March as the pandemic engulfed the world, it used a simple protocol that allowed doctors in overstretched hospitals anywhere to randomize their patients to whatever study drug was available or to standard care. To get four different drug strategies nailed down, and in this short period of time and across the world, is just fantastic, Topol says. I give them a lot of praise for getting us these results with extraordinary velocity. I think that Recovery and the Solidarity trial between them have set the standard of the scale thats required in order to give you clear answers, Farrar adds.

To get four different drug strategies nailed down, and in this short period of time and across the world, is just fantastic.

The biggest hurdle was the long time it took to get regulatory approval for the study in some countries, says WHOs Marie-Pierre Preziosi. Regulators, as well as the ethics committees for that matter, need to rethink their approaches in pandemics and need to be much more ready to cope with this because sometimes the duration for authorization is really not appropriate.

Still, the trial has ramped up to more than 11,000 patients from 30 countries, including Argentina, Peru, India, the Philippines, and Spain, with more slated to join. About 2000 patients are now included every month. For the moment, the remdesivir arm will continue to get more precise evidence, says John-Arne Rttingen, CEO of the Research Council of Norway, who heads the executive group of Solidaritys steering committee. But new drugs will be added, he says.

As early as next week, Solidarity participants could start to receive acalabrutinib, a cancer drug that inhibits an enzyme that plays an important role in the human immune system. The hope is to soon include targeted therapies such as monoclonal antibodies as well because they are more likely to be successful than repurposed drugs. Trying to find off-target benefits from FDA-approved drugs is not a great strategy (although arguably the best we can do under these conditions), tenOever wrote.

Solidarity built on experience from the 201416 Ebola epidemic in West Africa, says Ana Maria Henao Restrepo, who heads the Research and Development Group at WHO. Back then, there were many debates about whether it was even ethical to do randomized clinical trialswhich withhold a potential therapy from patients in control groupsduring a deadly outbreak. Now, you dont see any debate on that question, she says. The community, all of us, we have moved, we have learned a lot since West Africa.

The studys global reach has important benefits, says Nahid Bhadelia, a physician at Boston Medical Center. Conducting a trial in many places simultaneously means more patients can be included, leading to faster results but also to more robust data, she says. Youre including many different types of subgroups and populations in different parts of the world.

Another advantage: The 1300 participating doctors worldwide will have a sense of ownership of the results, Henao Restrepo says. When they see the results inThe New England Journal of Medicine, [they will] say, Ive contributed to that and I understand why that drug works or doesnt work. I know, I trust it, she says. That is different from some Northern Hemisphere group publishing, and they say: Somewhere in a rich country they did a trial and now we all have to believe the results.

Link:

Remdesivir and interferon fall flat in WHO's megastudy of COVID-19 treatments - Science Magazine