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Early results of COVID-19 treatment clinical trial promising, UAB doctors say

Eddie Burkhalter

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Preliminary results in a clinical trial for the drug remdesivir to treat COVID-19 patients shows promise that the drug is likely “going to be saving lives,” but the drug company will be challenged to make enough for those who’ll need it, said the doctor at the University of Alabama at Birmingham who oversaw the university’s portion of the trial. 

The National Institute of Allergy and Infectious Diseases on Wednesday released early results of a worldwide clinical trial, which showed that in a sample of 400 of the overall 1,063 coronavirus patients enrolled in the study, those who received remdesivir, rather than a placebo, recovered 31 percent faster. 

“It’s 31 percent effective over a placebo, which doesn’t sound fantastic, but it is likely going to be saving lives, and it gives the researchers direction on how to target this virus and come up with even better therapies,” said Dr. Paul Goepfert, professor of medicine in the UAB Division of Infectious Diseases and principal investigator in UAB’s clinical trial of the drug, during a video conference with reporters Wednesday. 

The California-based drug manufacturer Gilead Sciences owns the rights to remdesivir, which was developed with the help of UAB. It had previously been tested on Ebola patients, but with less promising results. 

NIAID chose UAB as one of 75 sites around the world, and the university enrolled 16 coronavirus patients into the clinical trial in late March. 

Dr. Nathan Erdmann, an infectious disease specialist at UAB who oversaw UAB’s patient enrollment in the clinical trial, said during the video conference Wednesday that a handful of the 16 patients are still being treated at UAB, and the reason for NIAID’s quick release of preliminary results was so that those still in the trial who may be receiving the placebo can begin to receive remdesivir. 

Goepfert cited NIAID director Dr. Anthony Fauci’s recent comments at a press conference on remdesivir, in which Fauci compared the drug to the HIV drug ACT, which had a limited impact HIV, but ushered in the creation of other drugs that did. 

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“I’m hoping that this will do the same for coronavirus,” Goepfert said. 

Remdesivir will likely become a standard treatment for COVID-19, Geopfert said, but there are other considerations when it comes to getting the drug to the patients. 

“The challenge is going to be for Gilead, the drug-maker, to come up with enough doses to treat the number of people that are going to need this,” Goepfert said.

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The drug will also replace any future placeboes in other trials, he said, which will require more doses. 

“But this is a very exciting time and I think it’s very hopeful. It certainly isn’t a home run at this point, but it is extremely hopeful that at least now we have something that can make a change in somebody’s life who has severe coronavirus infection,” Goepfert said. 

Asked how long it may take for the U.S. Food and Drug Administration to approve the drug for use with COVID-19 patients, Goepfert said that’s not clear yet but that “this is certainly going to be fast-tracked.” 

FDA Commissioner Stephen Hahn in an interview with Bloomberg News on Thursday said the administration is working at “lightning speed” to review the new data on the drug. 

“We’re working with the company to emphasize the necessity of speed while at the same time to understand the data,” Hahn told Bloomberg. “There will be a lot of factors that go into all the regulatory decisions. We want to look at the totality of data to make sure that remdesivir is targeted to the right patients.”

It’s also not yet clear whether remdesivir works better or worse on coronavirus patients who have other underlying medical conditions, Goepfert said, but that will come out when the full results are released later by NIAID. 

There remain more than 600 patients in the clinical trial worldwide, and the data will only get stronger as the trial continues, Goepfert said. 

Goepfert discussed another recent study released by researchers in China who studied remdesivir on coronavirus patients, which didn’t show the drug to be as effective for coronavirus patients. 

But the China study only enrolled around 200 patients, Geopfert said, compared to the NIAID study with more than 1,000. 

“And even if you look at that study, the remdesivir arm actually tended to do better. However, it didn’t reach statistical significance, which is very important in clinical trials,” Goepfert said. 

Erdmann said reports that the China study and the larger NIAID study conflict one-another is not accurate. 

“It’s not that the China study failed. It’s just a function of the limited numbers that they were able to enroll,” Erdmann said. 

The clinical trial results regarding the drug’s ability to prevent deaths from COVID-19 aren’t as clear, but Erdmann said there’s some early evidence of the drug’s ability to do just that. 

Asked if the drug is the “gamechanger” that researchers have been looking for in the fight against coronavirus, Erdmann said that’s “to be determined.” 

What is most relevant to this study is that researchers know now the drug that compared to a placebo has significant therapeutic benefits, Erdmann said. 

“We know that this is something that will actually help patients,” Erdmann said. “We need to determine how this drug can best be implemented. There’s all sorts of logistics involved with getting the drug available.” 

But the drug will “very likely” have an impact on how physicians treat COVID-19 patients going forward, Erdmann said. 

For 400 of those enrolled in the clinical trial, 10 days of treatments with the drug reduced the average hospitalization days time for COVID-19 patients from 15 days to 11. 

A separate study released by Gilead on Wednesday showed that there was little difference in health outcomes if patients were treated with the drug for just 5 days instead of 10. 

“That can have enormous implications for the amount of drug that’s available to treat patients going forward,” Goepfert said.

Eddie Burkhalter is a reporter at the Alabama Political Reporter. You can email him at [email protected] or reach him via Twitter.

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COVID-19 hospitalizations, new cases continue to rise

Eddie Burkhalter

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The number of rising hospitalized COVID-19 patients in Alabama is a concerning sign of a possible coming surge of the disease, state health experts said Friday. Alabama hospitals were caring for 888 coronavirus patients Friday, the highest number since Sept 9. 

UAB Hospital was caring for around 80 COVID-19 inpatients Friday afternoon, said Dr. Rachael Lee, an infectious disease specialist at UAB, speaking to reporters Friday. UAB Hospital hasn’t had that many coronavirus inpatients since Aug. 18, when the disease was surging statewide.

“We have been dealing with this since March, and I think it’s easy for us to drop our guard,” Lee said. 

Alabama added 3,852 new coronavirus cases on Friday, but 1,287 of them were older positive antigen tests, conducted in June through October and submitted to ADPH by a facility in Mobile, according to the department. Still, Alabama’s daily case count has been increasing, concerning health officials already worried that as the weather turns colder and the flu season ramps up, Alabama could see a surge like the state had in July.

Alabama’s 14-day average of new daily cases was 1,247 on Friday, the highest it’s been since Sept 4. Over the last 14 days, Alabama has added 17,451 new COVID-19 cases.

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Friday’s inclusion of those older positive test results throws off the day’s percent positivity, by Thursday the state’s percent of tests that were positive was nearly 16 percent. Public health officials say it should be at or below five percent or cases are going undetected.

The state added 16 COVID-19 deaths on Friday, bringing to total confirmed deaths statewide to 2,859. Over the last two weeks, 206 deaths were reported in the state. Alabama’s 14-day average of new daily deaths on Friday was 15.

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Alabama state health officer Dr. Scott Harris told APR by phone Friday called the rising new cases and hospitalizations “worrisome.”

Harris noted the data dump of older confirmed cases in Friday’s data, but said “but nevertheless, I think it’s clear our numbers are going up.”

Harris said it’s not yet clear what’s causing the continued spread, but said it may be due at least in part to larger private gatherings. ADPH staff has mentioned a few outbreaks association with such gatherings, but Harris said it’s hard to know for certain if that’s the major driver in the state’s rising numbers.

“It’s football season and the holidays are coming up and school is back in session,” Harris said. “I think people are just not being as safe as they were.”

Harris noted that on ADPH’s color-coded, risk indicator dashboard, red counties, which denotes counties with rising cases and percent positivity, the 17 red counties on Friday were distributed across the state.

“So there’s not one event, or even a handful of events. It seems like there’s just a lot of things happening in a lot of places,” Harris said.

Alabama’s rising numbers are mirrored in many states. The U.S. reported more than 71,600 new COVID-19 cases on Thursday, nearing the country’s record highs, set in July.

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Alabama’s COVID-19 hospitalizations, cases continue rise

Average daily hospitalizations continue an ongoing increase as cases nationwide surge.

Eddie Burkhalter

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(STOCK PHOTO)

The number of COVID-19 patients hospitalized in Alabama hit 863 on Wednesday, the highest daily count since Sept 4, as average daily hospitalizations continue a steady increase and cases nationwide surge.

UAB Hospital in Birmingham on Wednesday was caring for 72 COVID-19 inpatients — the highest number the hospital has cared for since Aug. 21. 

In the last two weeks, Alabama has reported an increase of 15,089 new COVID-19 cases, according to the Alabama Department of Public Health and APR‘s calculations.

That number is the largest increase over a 14-day period since the two weeks ending Sept. 9. On average, the state has reported 1,078 new cases per day over the last two weeks, the highest 14-day average since Sept. 9.

The state reported 1,390 new confirmed and probable cases Thursday. Over the last week, the state has reported 7,902 cases, the most in a seven-day period since the week ending Sept. 5. That’s an average of 1,129 cases per day over the last seven days.

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Alabama’s positivity rate, based on 14-day case and test increases, was nearly 16 percent Thursday, the highest that rate has been since mid-September.

Public health experts say the positivity rate, which measures the number of positive cases as a percentage of total tests, needs to be at or below 5 percent. Any higher, and experts say there’s not enough testing and cases are likely to be going undetected. 

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“I really won’t feel comfortable until we’re down to about 3 percent,” said Dr. Karen Landers, the state’s assistant health officer, speaking to APR last week

While new daily cases are beginning an upward trajectory, the number of tests administered statewide is not, contributing to the increasing positivity rate. The 14-day average of tests per day on Thursday was 6,856 — a nearly 10 percent decrease from two weeks prior. 

Over the last two weeks, ADPH reported 206 new COVID-19 deaths statewide, amounting to an average of 15 deaths per day over the last 14 days.

So far during the month of October, ADPH has reported 303 confirmed and probable COVID-19 deaths. In September, the total was 373. Since March, at least 2,843 people have died from the coronavirus.

The number of new cases nationwide appear to be headed toward a new high, according to data gathered by the COVID Tracking Project. The United States is now reporting nearly 60,000 cases per day based on a seven-day average. At least 213,672 Americans have died, according to the COVID Tracking Project.

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Doug Jones applauds signing of veterans mental health and suicide prevention bill

The legislation is aimed at bolstering the U.S. Department of Veterans Affairs mental health workforce to serve veterans. 

Eddie Burkhalter

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President Donald Trump over the weekend signed into law legislation cosponsored by Sen. Doug Jones, D-Alabama, that aims to bolster mental healthcare for veterans and address veteran suicides. 

“Too many veterans – in Alabama and across the country – lack access to affordable, compassionate and effective mental health care. Through increased access to local and innovative treatment options, this new law will help veterans get the life-saving mental health services they may need,” Jones, a member of the Armed Services Committee, said in a statement Wednesday.

U.S. Senator Jerry Moran, R-Kansas, and Sen. John Tester, D-Montana, introduced the landmark Commander John Scott Hannon Veterans Mental Health Care Improvement Act, which would bolster the U.S. Department of Veterans Affairs mental health workforce to serve veterans. 

The law also increases telehealth access for rural veterans, implements a pilot program to give veterans access to complementary care and establishes a grant program requiring the VA to better partner with agencies helping veterans to identify earlier those who are at risk of suicide. 

The law also strengthens how the VA will be held accountable for addressing veteran suicide, and it will allow the studying of the impact of living in high altitudes on veteran suicide risks and diagnostic biomarker research to identify depression, post-traumatic stress disorder, anxiety and other conditions.

More than 20 veterans die by suicide every day, the U.S. Department of Veterans Affairs estimates, and of those, 14 have received no treatment or care from VA. 

“The social isolation and increased anxiety caused by the COVID-19 pandemic has only exacerbated many of the issues our veterans face,” the senators wrote in a letter to Senate leadership before it was approved and signed into law by the president. “Our nation’s veterans and their families are waiting on Congress to take action to deliver these desperately needed resources. We must act now to provide this vital assistance to Americans who have sacrificed so much for our country and who deserve the best our nation has to offer. As such, we are seeking immediate passage of S. 785 when the U.S. House of Representatives reconvenes in September.”

The law is named in honor of
Commander John Scott Hannon, a member of the Navy SEALs who served in the U.S. Navy for 23 years. Hannon was helping other veterans even while he was receiving mental health treatment himself. He died by suicide on Feb. 25, 2018.

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Veterans can call the Veterans Crisis Line at 800-273-8255, and then press 1, or text to 838255. 

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AARP’s COVID-19 dashboard shows Alabama nursing home lagging behind national averages

In each of five parameters Alabama fared worse than the national average.

Eddie Burkhalter

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A recently-released dashboard shows that Alabama’s nursing homes, residents and staff alike, are suffering due to the COVID-19 pandemic, and there’s concern over what may happen in the coming days and weeks. 

“We know we’re moving into a very dangerous time right now, with flu season, and weather getting colder and people moving indoors,” said AARP Alabama spokeswoman Jamie Harding, speaking to APR on Monday. 

AARP partnered with the Scripps Gerontology Center at Miami University in Ohio in the creation of the dashboard, which in this first set uses data from the Centers for Medicare and Medicaid Services to look at five parameters for the four-week period ended Sept. 20. 

In each of the five parameters — nursing home resident deaths per 100 residents, resident cases per 100 residents, staff cases per 100 residents, supply of personal protective equipment and staffing shortages — Alabama fared worse than the national average.

In the last month, there were 1.03 COVID-19 deaths among Alabama nursing home residents per 100 residents, tying with Mississippi as the second highest death rate in the nation, coming just behind South Carolina, which had the most, at 1.2 deaths per 100 residents, according to the AARP reports. 

As of Oct. 14, 45 percent of Alabama’s total COVID-19 deaths since the start of the pandemic were among nursing home residents, totaling 1,088 resident deaths at the time, according to the dashboard. For the four weeks ending Sept. 20, nursing home residents made up 48 percent of the state’s deaths. 

Harding also noted that by the time CMS publishes the nursing home data “it’s about two to three weeks old” so the public isn’t getting up-to-date information on what’s happening in nursing homes, but she said at least the AARP’s dashboard will show trends in the data over time. 

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“We want the state, we want our leadership to take this data seriously, to see that we are not performing well on these five metrics, which are very critical metrics, and we want to know how this is going to be addressed,” Harding said. 

The Alabama Department of Public Health has declined to release county-level or facility-level details on coronavirus in long-term care facilities and nursing homes, citing privacy concerns. 

“So that’s the problem, and Alabama has stubbornly refused to release daily reports, and remains one of just a handful of states still refusing to release the daily report, and we really have no good answer,” Harding said. 

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Harding also discussed a COVID-19 outbreak at the Attalla Health and Rehab, first reported by AL.com, in which the facility had to be evacuated due to a huge spike in cases there, peaking on July 10. Some residents were taken to a local hospital, while others were taken to Gadsden Health and Rehab and Trussville Health and Rehab, sparking an outbreak of COVID-19 at Trussville Health and Rehab. 

AL.com’s reporting noted that while at least 10 states have special strike teams ready to send staff and supplies to nursing homes experiencing an outbreak, Alabama does not. 

The new outlet quoted Dr. Karen Landers, assistant state health officer with the Alabama Department of Public Health as saying that the department doesn’t have the staffing to form such teams. 

“That is an indication that this was a problem they were never prepared for, and they should have been,” Harding said.  “They are the Department of Public Health. This is their work. This is their job.” 

Harding also said that as of at least the end of September, the Alabama Nursing Home Association hadn’t yet begun spending the $50 million in CARES Act funds, which Gov. Kay Ivey announced on Aug. 7 would be made available to reimburse state nursing homes via the hospital association’s Education Foundation for the cost of fighting against COVID-19. 

John Matson, ANHA’s spokesman, told ABC 33/40 reported on Sept. 28 that the funds were in a holding account and the first claims should be paid in early October. Matson said an accounting firm had been hired  to help handle the administration of the funds. 

Harding expressed concern that the federal aid wasn’t being spent to help protect state nursing homes quickly enough, and said that the Attalla nursing home outbreak was made worse by a staffing shortage as workers either became sick themselves or quit to protect themselves and their loved ones. Alabama nursing homes weren’t overstaffed before the pandemic, she said. 

“We would like to see some of that $50 million dollars spent to address staffing emergencies,” Harding said. 

Matson, in a response to APR on Monday, said that since mid-March, Alabama’s nursing homes have been in the center of a fight to defend the most vulnerable citizens of our state from the most insidious and infectious virus attack in the last century. 

“Every resource has been pushed to the extreme,” Matson said. “While critics have the luxury of creating dashboards generated from government databases, the caregivers of Alabama’s nursing homes have relentlessly fought day-by-day, risking their own health, to care for the residents who depend on us. Our people are heroes and our nursing homes have met an unprecedented challenge.” 

Matson said every dollar of the $50 million spent must be justified by documentation, every claim is to be audited by an independent auditing firm before reimbursements are approved and ANHA filed regular reports to the Alabama Department of Finance which are publicly viewable. 

ANHA’s report for September, filed Oct. 15, states that many facilities were just then become eligible to apply for some of those $50 million due to requirements that the facilities deduct from amounts claimed any other coronavirus aid the facility may have received from other sources, such as the “Medicaid COVID add-on of $20 per day per Medicaid patient, DHHS Provider Relief Funds; and SBA payroll Protection payment loans attributable to payroll, if any.” 

“Therefore, due to the application of these mitigants, many facilities are just now becoming eligible to apply for and receive funds,” the report reads. 

The September report also states that to guard against funds not being available “in the event of a second or later COVID-19 wave, the Foundation is holding back 25% of approved claims.” 

The report also says that 12 facilities as of Sept. 30 were approved for $6.5 million in claims, with $1.6 to be held back for possible future COVID-19 waves. As of Oct. 13, there were $10.4 million in pending claims filed by 65 facilities, according to the report, and there were $16.9 million on total claims paid or pending.

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