The University of Alabama at Birmingham has been selected as a site for clinical trials of a drug that could potentially treat hospitalized COVID-19 patients.
The National Institute of Allergy and Infectious Diseases chose UAB as one of 75 sites around the world, and enrollment in what is phase three of the clinical trials began immediately, according to UAB News.
There are currently no treatments for the virus, but scientists across the globe are rushing to try to develop one.
Paul Goepfert, M.D., professor of medicine in the UAB Division of Infectious Diseases, will serve as UAB’s principal investigator for this study.
“Remdesivir worked well in the test tube and animal models against a close relative of COVID-19,” Goepfert said in a statement. “We are very excited to have the opportunity to rapidly determine whether this drug will help treat hospitalized patients with COVID-19 here at UAB.”
“COVID-19 is rapidly spreading throughout the world, and the U.S. now has the third-highest number of cases in the world, with more than 50,000 patients,” Goepfert said, “Although the first case of COVID-19 in Alabama was diagnosed just over a week ago, we now have more than 200 cases in our state.”
There were 466 confirmed COVID-19 cases across Alabama as of Thursday morning. Alabama’s first death from the virus was confirmed Wednesday in Jackson County.
APR reported on Wednesday that there were more than 100 people hospitalized statewide with a confirmed diagnosis of COVID-19 or illness the hospital highly suspects as being COVID-19.
At UAB, 60 total COVID-19 patients were hospitalized as of Wednesday morning. More than half of those were on ventilators.
Gov. Kay Ivey extends statewide mask order, allows limited nursing home visitations
“This mask ordinance is working. It works, and we have evidence of that,” State Health Officer Scott Harris said.
Gov. Kay Ivey on Wednesday extended Alabama’s statewide mask order, citing the upcoming general election and a reduction in the spread of the virus since her order went into effect in July. Ivey’s new order also allows for limited visitations in state nursing homes, and keeps all other previous social distancing restrictions in place.
“I’d hate to see us pull back too quickly and negate the progress that we’ve made in our daily positive numbers and our hospitalization rates by risking another spike due to a false sense of security, the upcoming winter months, the flu season and a host of other reasons,” Ivey said during a press conference Wednesday.
Ivey said that with the Nov. 3 Election Day nearing “it’s important to have a safe environment where our poll workers poll watchers, and those of us who would like to vote in person.”
Ivey said that voters aren’t required to wear a mask to vote in person, “I’m certainly going to wear my mask because I want to protect the poll workers and others that are going into the polls as well.”
Alabama State Health Officer Dr. Scott Harris said state hospitals are caring for about half the number of COVID-19 patients than were hospitalized in late July, during a surge in cases, hospitalizations and deaths, and just before the mask order was issued.
“This mask ordinance is working. It works, and we have evidence of that,” Harris said. “There have not been any additional restrictions imposed on our state since this Stay at Home order at the end of April.”
Harris noted an August study released by the South Carolina Department of Health and Environmental Control that looked at that state’s jurisdictional mask orders, and found that in the 40 percent of jurisdictions that have mask orders COVID-19 cases were reduced by nearly half, compared to an increase in cases by 30 percent in jurisdictions without mask orders.
White House Coronavirus Task Force Member Dr. Deborah Birx during a visit to Alabama last week urged Ivey to extend the mask order. Birx had praised Ivey’s statewide mask mandate during a previous visit to the state in July, when nine of the first 13 days of that month saw daily case increases in COVID-19 cases statewide of more than 1,000.
Ivey’s amended “safer-at-home” order also states that beginning Friday, hospitals and nursing homes shall ensure that each patient or resident can have one caregiver or visitor at a time, with some exceptions.
Ivey’s order states that the changes are “subject to reasonable restrictions imposed on the entrance of persons because of the COVID-19 county positivity rate, the facility’s COVID-19 status, a patient’s or resident’s COVID-19 status, caregiver/visitor symptoms, lack of adherence to proper infection control practices, or other relevant factors related to the COVID-19 pandemic, consistent with the following guidance from the federal government,” and goes on to list links to Centers for Medicaid and Medicaid Services guidance for the different facilities.
Ivey said during the Wednesday press conference that none of her previous statewide orders prevented anyone from accompanying a loved one into a hospital, and said despite that, there has been some confusion on the matter. She said her amended order made that fact clear.
Dr. Don Williamson, president of the Alabama Hospital Association, told The Montgomery Advertiser in June that hospitals have control over visitations. Hospitals statewide have enacted individual varying rules on visitations since the start of the COVID-19 pandemic.
Harris also discussed the work being done to ready the state for disbursement of a vaccine, if and when one becomes available. Harris said a plan for doing so must be given to the U.S. Department of Health and Human Services by mid-October.
“Obviously, we’re following very closely the safety data and efficacy data so that we are sure that we have a vaccine product that’s going to be safe and effective,” Harris said. “And I’m confident that information will be available for us, and then we can make a really good decision on that as we start to receive this vaccine.”
Harris said the supply of a vaccine will initially be limited, and state health officials will have to prioritize disbursement for high-risk people, including health care workers, but that the state will release its plan to do so to ensure openness in the process.
Alabama ABC Board rescinds alcohol sales curfew
On Tuesday, the Board approved a new order, which notes that the 50 percent occupancy requirement remains in place.
The Alabama Alcoholic Beverage Control Board on Tuesday voted to rescind a previous order that forced bars and restaurants to stop serving alcohol after 11 p.m. The measure went into effect immediately upon their vote.
Board members on July 27 unanimously voted to enact the 11 p.m. alcohol sales curfew as cases of COVID-19 were surging statewide and Alabama’s ICU beds were filling with patients stricken with the disease.
On Tuesday, the Board approved a new order, which notes that the 50 percent occupancy requirement remains in place. Customers and workers must also wear masks, if not eating or drinking, and remain six feet from others, according to the order.
The Board’s decision to rescind the curfew comes as the number of new COVID-19 cases in Alabama have declined following Gov. Kay Ivey’s statewide mask order in mid-July, but public health officials remain concerned that the number of COVID-19 patients in state hospitals remains too high.
Alabama State Health Officer Dr. Scott Harris told APR on Tuesday that while the state has made improvements since a surge in cases in July, and the number of hospitalized coronavirus patients in Alabama is about half what it was in early August, “they’re still a lot higher than they were back in the spring, so I wish we would continue to see more improvement, but I think we’re definitely much better than we were a couple of months ago.”
Dr. Deborah Birx, the coordinator of the White House’s coronavirus task force, suggested to Ivey and Harris on her July visit to the state that Alabama close its bars, which health officials say can be breeding grounds for the spread of COVID-19.
One of Ivey’s advisors suggested closing the state’s bars, but the board was instead tasked with finding a different solution, board administrator Mac Gipson told board members during the July 27 meeting prior to the vote to enact the curfew.
The plan at first was to cut off alcohol sales at 10 p.m., Gipson said at the July meeting, but bar owners contacted the board over concerns about potential losses in revenue, so it was pushed back to 11 p.m.
Tuscaloosa Mayor Walt Maddox on Saturday issued a warning that tickets would be issued for bars that exceeded the city’s 50 percent occupancy limit.
Maddox was responding to photos posted to the Facebook page of the band The Velcro Pygmies playing live at the Tuscaloosa bar Rhythm and Brews, where patrons were tightly packed together and not wearing masks. The post was later deleted after going viral.
Maddox in August ordered the city’s bars to shut down for two weeks in an effort to slow the spread of COVID-19.
Governor: Alabama will get 1 million rapid antigen COVID-19 tests
The state is to receive the Abbott Laboratories BinaxNow rapid tests in phases over the next few months. The initial shipment is set to include approximately 96,000 tests.
Gov. Kay Ivey on Tuesday announced that the Trump administration is to send 1 million new rapid COVID-19 tests to Alabama, but the details on their use was still being worked out.
Ivey’s office announced in a press release that the state is to receive the Abbott Laboratories BinaxNow rapid tests in phases over the next few months, and that the initial shipment is to be of approximately 96,000 tests.
It was unclear Tuesday who will get the tests or whether the results will be required to be reported to The Alabama Department of Public Health (ADPH), however. In a statement Ivey said while we await a vaccine “providing Alabamians – especially our students and vulnerable citizens – with this free resource will be another critical tool in the toolbox to combat COVID-19.”
Our Office is working in coordination with Public Health as we firm up plans for distribution. We are working to ensure students and high-risk individuals have access to this resource,” said Gina Maiola, Ivey’s press secretary, in a response to APR’s questions Tuesday.
Questions to ADPH on Tuesday weren’t immediately responded to.
The U.S. Food and Drug Administration on Aug. 26 gave an emergency use authorization to Abbott laboratories for the rapid antigen tests, which is the first of its kind to require no lab equipment.
The USDA on Sept. 18 reissued an emergency use declaration, changing wording to say that the tests are to be used “within the first seven days of the onset of symptoms” and that “testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities.”
“Studies have shown that antigen levels in some patients who have been symptomatic for more than five days may drop below the limit of detection of the test. This may result in a negative test result, while a more sensitive test, such as RT-PCR, may return a positive result,” the Centers for Disease Control and Prevention said in guidance on the use of antigen tests.
The Trump administration approved a $760 million contract with the company to produce about 150 million tests.
“We’ll ship tens of millions of tests in September, ramping production to 50 million tests a month in October,” Abbott Laboratories said on the company’s website.
Other governors were making similar statements Tuesday about pending Abbott Laboratory tests coming to their states.
President Donal Trump on Monday announced plans to ship 100 million of the tests to states based upon population.
“Governors have the flexibility to use these tests as they deem fit, but we strongly encourage governors to utilize them in settings that are uniquely in need of rapid, low-tech, point-of- care tests, like opening and keeping open our K-through-12 schools; supporting critical infrastructure and first responders; responding to outbreak, specifically in certain demographics or locations; and screening of surveillance in congregate settings,” said Adm. Brett Giroir, the U.S. Department of Health and Human Services official in charge of COVID-19 testing for the White House’s coronavirus task force, speaking with Trump from the Rose Garden on Monday.
The Abbott Laboratories rapid antigen tests, which use a swab and a small card and can provide results within 15 minutes, have some similarities to existing antigen tests now being used across Alabama, which use small machines to provide quick results.
ADPH has struggled at times to get results from those existing rapid antigen tests, which are often used in non-traditional lab settings, such as nursing homes, universities and urgent care clinics, some of which aren’t accustomed to ADPH’s reporting process.
Dr. Karen Landers, an assistant state health officer for ADPH, told Kaiser Health News last week that she was concerned about the undercounting of antigen test results, and that some providers were struggling to submit results.
“We can’t afford to miss a case,” Landers told the news outlet.
Delayed reporting caused spike in Alabama’s daily COVID-19 count
Two large labs were improperly reporting COVID-19 testing data to the Alabama Department of Public Health, and a data dump from those labs resulted in the state’s largest single day spike in new daily cases on Sept. 25.
Two large labs were improperly reporting COVID-19 testing data to the Alabama Department of Public Health, and a data dump from those labs resulted in the state’s largest single day spike in new daily cases on Sept. 25 when 2,452 cases were reported.
Alabama State Health Officer Dr. Scott Harris told APR on Tuesday that once those two labs sent in a mass of old test results electronically to ADPH — almost all of them point-of-care antigen tests — those results caused the spike in new daily cases.
“ADPH continues to make all efforts possible to identify new labs and bring them into the electronic reporting process in order to capture the positive and negative labs for case investigation and data accuracy,” the department said in a statement regarding the recent data dump.
In addition to the large batch of backlogged positive antigen tests on Sept. 25, the state has also begun including probable tests — largely those positives from antigen tests — in both its statewide and county-by-county data, which APR uses to populate its charts. The state began reporting probable cases and deaths on the statewide level on May 30, and began including those totals in graphs on Sept. 1.
(Because ADPH has been reporting probable cases and deaths since May 30, APR was able to adjust our charts back to May 30 beginning Sept. 1 without the addition of the probable cases causing a huge spike.)
On the county level, though, probable cases and deaths were not reported at all until Sept. 25, when the full total of every probable case was added to county charts. The addition of those probable cases made some counties appear to have even larger spikes than the statewide increase on Sept. 25, which was already the largest increase to date because of the backlogged positives from the labs improperly reporting positives.
(The addition of the new probable cases have also affected other measures APR calculates based on those cumulative and daily totals including seven-day averages, 14-day averages and percent positivity.)
For example, many counties over the past week have reported more positive cases than total tests, which would be impossible without the data delay and the addition of probable cases. Some counties, like Lee County and Tuscaloosa County, showed such large increases on Sept. 25 that their positive totals on that day alone appear to outmatch the statewide increase.
That, again, is because the statewide total was already including probable cases beginning Sept. 1 and daily probable data was available back to May 30, but county level data did not include probable cases until Sept. 25.
Harris said it’s not uncommon for some labs to hold off reporting test results for a couple of weeks, then submit them all at once. Smaller commercial labs that don’t amass many tests often wait until a batch has been accumulated to submit.
Two labs sent in a large batch of older negative test results to the state in August, which skewed charts that use that data to track new daily tests and percent positivity. A similar artificial dip and spike in statewide COVID-19 data in early June was the result of computer system problems.
Speaking on the current state of COVID-19 in Alabama, Harris said “we’re cautiously optimistic about where we are” and noted that unlike the spike in new cases, hospitalizations and deaths statewide after Memorial Day into July, the most recent Labor Day holiday does not seem to have resulted in larger numbers.
“We did not appreciate a big spike after Labor Day, which was very, very encouraging,” Harris said.
Harris noted that the state hasn’t imposed any new restrictions since May, other than the statewide mask order in mid-July, which was followed by a decline of new confirmed COVID-19 cases.
“I will say, we still have room to improve. The hospital numbers now are about half of where they were in early August,” Harris said. “Yet they’re still a lot higher than they were back in the spring, so I wish we would continue to see more improvement, but I think we’re definitely much better than we were a couple of months ago.”
Gov. Kay Ivey’s statewide mask order is set to expire Friday, but Ivey and Harris are expected to make an announcement about whether it will be extended. Harris said Ivey’s coronavirus task force is to have a conference call Tuesday afternoon and that an announcement would likely come soon.