A USF Health study finds that a screening test for major blood clots in the lungs, originally validated in seriously ill non-COVID patients, works as well for COVID patients

Human lung tissue with pulmonary embolism under a microscope

TAMPA, Fla. (Oct. 26, 2021) — A screening blood test originally validated in seriously ill patients without COVID-19 is still clinically useful for ruling out pulmonary embolism in patients hospitalized with the coronavirus, a University of South Florida Health (USF Health) Morsani College of Medicine research team reports.

Principal investigator Asa Oxner, MD, and USF Health colleagues published a single-center, diagnostic study Oct. 8 in JAMA Network Open investigating how well D-dimer testing performed at excluding pulmonary embolism in patients hospitalized with COVID-19. Doctors who suspect pulmonary embolisms routinely rely on widely available D-dimer screening to rule out the potentially life-threatening blood clotting disorder – most commonly in surgical patients immobilized for long periods and patients admitted to intensive care units.

D-dimer is a simple blood test that measures protein fragments of blood clots floating in the bloodstream. D-dimer levels, normally undetectable or detectable at very low levels, rise sharply when the body is breaking down the clots.

“Our study found that clinicians can feel confident interpreting the D-dimer levels the same in COVID patients as they do in every other patient; we don’t need a special (different) value for COVID patients,” said Dr. Oxner, associate professor and vice chair of USF Health Internal Medicine. “So, in hospitalized COVID patients, we can appropriately rule out a pulmonary embolism if d-dimer levels are low.”

Pulmonary embolisms occur when blood clots that form in another part of the body (often the leg), travel through the bloodstream, and lodge in the blood vessels of the lung, decreasing blood flow and causing low oxygen levels.

Research indicates COVID-19 patients are three to 10 times more likely to develop pulmonary embolisms than other hospitalized patients, even when they are not as seriously ill or immobilized, Dr. Oxner said. Scientists are still investigating why, but it appears the COVID-19 virus may create a cellular environment that promotes clotting by making the inside of blood vessels uneven, irritated, and prone to microtears.

Asa Oxner, MD, is as associate professor and vice chair of USF Health Internal Medicine.

A negative D-dimer test (one that rules out pulmonary embolism) can help patients avoid more expensive, invasive diagnostic tests, like a computed tomography pulmonary angiogram, or CTPA. “CPTA can be dangerous because the patient, who potentially has a blood clot, must lay immobile in the CT scanner for quite a while to capture (pulmonary artery) images. The test also requires injection with IV contrast, which carries a greater risk of kidney damage when you’re very sick,” Dr. Oxner said.

The USF Health researchers wondered if the increased risk for blood clotting in COVID-19 patients, and uncertainty of diverse D-dimer values found in earlier smaller studies, reduced the existing screening tool’s ability to correctly rule out pulmonary embolism in COVID patients. The conventional thinking was that D-dimer levels would almost always be high in COVID-19 patients, therefore the test as originally validated (in non-COVID patients) would not be accurate at differentiating COVID patients without clots, Dr. Oxner noted.

The retrospective study looked at the records of 1,541 patients hospitalized with COVID-19 at Tampa General Hospital from Jan. 1, 2020, to Feb. 5, 2021. They compared plasma D-dimer concentrations with CTPA, the criterion for diagnosing pulmonary embolism, in 287 of those patients. All COVID-19 patients with CTPA evidence of pulmonary embolism had D-dimer levels of 0.05 μg/mL or greater, as did the majority (91.2%) of patients without CTPA evidence of pulmonary embolism. (Concentrations of 0.05 μg/mL and higher are considered positive for pulmonary embolism, while anything below that D-dimer level is negative.)

The researchers also analyzed whether changing the cutoff levels defining positive or negative D-dimer test results specifically for the COVID patient population might improve the test’s performance. “We did not find that to be statistically significant; however, we may have been able to identify a different cutoff level if the study had more COVID patients,” Dr. Oxner said.

Within the limitations of this single-center study, setting higher D-dimer thresholds was associated with improved specificity – but at “the cost of an increased false-negative rate that could be associated with an unacceptable patient safety risk,” the study authors wrote.  A false-negative result means that the test does not detect a pulmonary embolism when the serious blood clotting problem is very likely present.

Doctors who suspect pulmonary embolisms routinely rely on widely available D-dimer screening to rule out the potentially life-threatening blood clotting disorder.

While clinicians must maintain heightened suspicion for pulmonary embolisms when evaluating symptoms in COVID-19 patients, the overall USF Health study results indicate that the currently available D-dimer test adequately screens for the likelihood of pulmonary embolism in hospitalized COVID patients, Dr. Oxner said. “The mechanisms of developing pulmonary embolisms may differ for COVID patients, but the resulting physiology is the same for all patients. The little fragments of (undissolved) blood clots are still detectable with D-dimer.”

USF Health internal medicine resident Constantine Logothetis, MD, was lead author for the study.

A study by USF Health and Tampa General Hospital among the first to assess effectiveness of MABs in a practical setting when given to patients at high risk for severe COVID-19

TAMPA, Fla. (June 24, 2021) — A recently published study by the University of South Florida Health (USF Health) and Tampa General Hospital (TGH) shows that monoclonal antibodies (MABs) work well in reducing COVID-19 related emergency department visits and hospitalizations when given early to high-risk patients. If used under FDA guidelines, the researchers suggest, this treatment can ease the pandemic’s continuing burden on patients and on limited health care resources.

The collaborative study was published June 4 in Open Forum Infectious Diseases.

Investigational monoclonal antibody therapies, administered intravenously, are specifically designed to block infection by SARS-CoV-2, the virus that causes COVID-19. The FDA has granted emergency use authorization (EUA) of MABs in outpatients with mild-to-moderate COVID-19 at increased risk of developing severe disease. Such high-risk patients are prone to hospitalizations, mechanical ventilation and other complications, including death from coronavirus.

“While the emphasis now is rightfully on getting more vaccines in arms, thousands of people in the U.S. are still infected with COVID-19 every day and a significant number suffer serious complications,” said the study’s senior author Asa Oxner, MD, associate professor and vice chair of the Department of Internal Medicine, USF Health Morsani College of Medicine.

“Unfortunately, only a fraction of those outpatients eligible for monoclonal antibodies receive them,” Dr. Oxner said. “We hope results like ours reinforce to the public and health care providers the importance of targeting timely monoclonal antibody treatment to this high-risk patient population to help minimize stress on health care systems during the COVID-19 pandemic.”

Limited clinical trials previously indicated that MABs work best when given soon after diagnosis. But this USF Health-TGH collaborative study was one of the first to evaluate the practical effectiveness of MABs when administered exclusively to patients deemed at high risk for progression to severe COVID-19. The FDA defines medical conditions and factors that place adults and children age 12 or older at higher risk for COVID-19, including older age (65 plus), obesity, diabetes, immunosuppressive disorders or treatment, chronic lung diseases and cardiovascular disease, to name a few.

Asa Oxner, MD

The academic medical center’s retrospective study, conducted Nov 18, 2020, to Jan. 5, 2021, included high-risk outpatients with a confirmed COVID-19 diagnosis, all experiencing mild-to-moderate symptoms for 10 days or less. A group of 200 patients received one of two MAB therapies (a single infusion) – either casirivimab/imdevimab, a combination drug made by Regeneron, or the medication bamlanivimab made by Eli Lilly. This treatment group was compared against a control group of 200 randomly selected outpatients who declined or were not referred for MABs during the same period.

Among the findings:

• Overall, patients treated with the MABs were significantly less likely to be hospitalized or visit the emergency department (13.5%) than the control patients (40.5%). These results remained significant when comparing the individual monoclonal antibody therapies against the control group.
• No deaths were reported in the MABs-treated group, compared to 3.5% in the control group.
• Patients treated with MABs within six days of symptom onset were significantly less likely to be hospitalized or visit the emergency department (7.7%) than those treated after six days (28.1%). The study data indicated MABs are best given within seven days of initial symptoms to reduce the odds of hospitalization within 29 days of infusion.

“Reflecting on our findings, it would be prudent to consider decreasing the FDA eligibility window for MABs to within seven days of symptom onset,” the study authors write. “These medications are a relatively scarce resource, and it would be practical to administer them to patients who are likely to see the most benefit.”

COVID-19 has strained financial and personnel resources across all health systems, with the Florida Hospital Association estimating total losses of $7.4 billion from the beginning of the pandemic through August 2020. The study authors conclude that maximizing the use of monoclonal antibody therapies under EUA guidance has the potential to “keep high-risk COVID-19 patients out of the hospital and reduce the negative impact on the health care system.”

The study co-lead authors were Nicholas Piccicacco, PharmD, and Kristen Zeitler, PharmD, of the TGH Department of Pharmacy.

***
The FDA revoked its EAU of bamlanivimab in April 2021, based on evidence showing sustained increase in COVID-19 viral variants resistant to that particular MAB when given alone. The monoclonal antibody cocktail of bamlanivimab combined with etesevimab is still an FDA EUA antibody option.

***
The REGEN-COV casirivimab/imdevimab MAB cocktail demonstrated potency against the main variants of concern in the laboratory and is the only antibody therapy currently available across the U.S., including states where variants first identified in Brazil and South Africa are circulating at a higher rate.

Since the launch of the COVID Confirmed (COCO) Clinic in early April, over 4,700 patients with COVID-19 have been given virtual follow-up services after being discharged from the hospital. Not only has this virtual outpatient clinic helped patients on their road to full recovery and often kept them from being readmitted to the hospital, it also provided resident physicians and senior medical, nurse practitioner, physician assistant, PharmD, social work and behavioral health students, with a place to complete their clinical rotations. In mid-March, the Association of American Medical Colleges (AAMC) issued new guidance for medical student clinical rotations during the coronavirus which stated that it, “strongly supports medical schools pausing all student clinical rotations, effective immediately, until at least March 31,” due to concerns about the availability of personal protective equipment (PPE) and to give time for appropriate educational strategies and alternative clinical experiences to be developed and implemented.

Volunteers and trainees played vital roles within the clinic which included conducting regular welfare checks, offering support and discussing any symptoms that haven’t been resolved. Social work and behavioral health students were not originally part of the COCO Clinic when it first launched, but the team quickly realized that COVID-19 and quarantine could severely impact a patient’s mental health and so the interprofessional team expanded. The medical, social, and mental health assessments screened for depression, anxiety and substance abuse, and if a patient answered “yes” to any of the questions, they were offered resources or referrals to support. According to Asa Oxner, MD, FACP, COCO Clinic operations director, one patient agreed to being referred to the mental health team of COCO and a real suicide attempt was mitigated.

In addition to regular follow-up assessments, nurse practitioner students were in charge of monitoring the dashboard that displays the oxygen levels and heart rates of high-risk patients who were wearing a special device on their wrist.

A patient wearing one of the COCO Clinic’s monitors. Photo by CBS affiliate, 10 Tampa Bay, from their, “COVID-19 Telehealth Clinic Getting Overloaded with Tampa Bay Patients” video.

“Volunteering with the clinic has been a unique educational experience. The clinic administrators do a great job of turning every opportunity into a teaching moment,” said Joshua Mizels, Morsani College of Medicine fourth-year medical student and past clinic volunteer. “My classmates who all volunteer have had the opportunity to keep interacting with patients, giving us the opportunity to learn more about what they are going through during this pandemic.  The experience from this opportunity has been invaluable toward my medical education. ”

Lucy Guerra, MD, MPH, FACP, and Asa Oxner, MD, FACP, co-coordinators of the COCO Clinic, along with Elimarys Perez-Colon, MD, medical director, Christine Jennings, RN, nurse manager, and Rachelle Idziak, MD, data manager, led the effort to get the clinic up and running and play a pivotal role in helping the community. For their dedicated efforts, the doctors received a USF Health Culture Coin from Chief Medical Officer, Dr. Mark Mosely.

Dr. Asa Oxner (left) and Lucy Guerra (right), COCO Clinic co-coordinators, were presented with USF Health culture coins by Dr. Mark Moseley, USF Health chief medical officer, for leading efforts to get the virtual clinic up and running.

“We have been successful in offering close follow up to patients keeping them out of the hospital when able, monitor patient’s vital signs remotely to identify patients at higher risk, safely linking patients to care and offering education and reassurance to patients with COVID19 in the Hillsborough county,” said Dr. Elimarys Perez-Colon, assistant professor of medicine, vice chief of medicine at Tampa General Hospital, and medical director of the COVID-19 Confirmed Clinic. “The data collected will assist our department of health to better understand the distribution and epidemiology of COVID19 in our county. This effort wouldn’t have been successful without the assistance and compassionate care offered by our trainees.” In the first three months, over 150 trainees played a part in the care of patients.

The COCO Clinic has been the talk of the town, featured in news stories by ABC Action News, Baynews 9, 10 Tampa Bay, among others.

After the success of the virtual clinic for COVID-19 patients, clinic leaders began working with partners at Tampa General Hospital and the Florida Department of Health to make the clinic a permanent resource for the community. As of November 12th, the COCO Clinic transitioned management of the clinic to TGH and became the TGH Transitional Care Center. “This transition will allow the clinic to continue operating and provide excellent care to our patients impacted by COVID-19, while allowing USF Quality and Clinical Operations Department staff who have been assisting the COCO clinic to return to their normal non-COVID duties,” said Dr. Moseley. “The clinic will continue to provide hours to our medical, pharmacy, and nurse practitioner students and our teaching attendings will continue to support the clinic. TGH has also been able to hire several RNs and Mas, who have been training in the current clinic and will be able to facilitate a smooth transition.” An emphasis will be put on taking care of COVID-19 ‘long haulers,’ virus survivors who continue to have side effects weeks, or months, after surviving the coronavirus. Caring for these patients will also help conduct research into the little known long term effects of COVID-19. Beyond COVID-19, the clinic can continue to help patients using the same monitoring and staffing model, but for serious chronic diseases such as heart failure or chronic obstructive pulmonary disease (COPD).

A survey of resident physicians in Florida indicates they are interested in treating opioid addiction but face barriers to offering patients treatment using buprenorphine, an FDA-approved medication shown to successfully decrease opioid use, overdose events, and deaths associated with opioids.

Resident physicians often care for patients with opioid addiction, described in medical terms as Opioid Use Disorder (OUD), but do not have the skill set or knowledge to treat OUD.

These are the findings by USF Health physician researchers that were recently published in the Journal of Addiction Medicine. The study is one of the first to evaluate what barriers resident physicians face in prescribing buprenorphine for opioid addiction and their attitudes towards treating opioid addiction.

Currently, health care providers must complete training in order to obtain a waiver to prescribe buprenorphine, but only 5% of all practicing physicians have this waiver.

The USF Health researchers surveyed resident physicians across all 35 Internal Medicine residency training programs in Florida that are accredited by the Accreditation Council for Graduate Medical Education (ACGME). Resident physicians are medical school graduates receiving doctor-supervised training in hospitals, clinics and other medical settings to become specialists. They found that 42% of respondents planned to obtain a buprenorphine waiver and that only 3% of these residents were currently waivered.

Dr. Bryant Shuey

“The opioid epidemic continues to claim over 45,000 deaths per year –unfortunately, only 20% of patients with opioid addiction receive medical treatment. Medications like buprenorphine can radically improve the lives of people who have opioid addiction, but these medications are underutilized by providers,” said the study’s lead author Bryant Shuey, MD, a third-year resident for the Department of Internal Medicine in the USF Health Morsani College of Medicine in Tampa, Fla.

“Providers must complete a training in order to obtain a waiver to prescribe buprenorphine. But only 5% of practicing physicians have this waiver, leaving few prescribers prepared to address the opioid epidemic. Resident physicians are the front line of our health care workforce and are poised to be leaders in treating opioid addiction. Yet, few studies have evaluated what residents know about opioid addiction and what barriers they face when trying to manage opioid addiction. This study is one of the first to evaluate what barriers resident physicians face in prescribing buprenorphine for opioid addiction and their attitudes towards treating opioid addiction.”

The survey also found that:

• 73% of residents cared for patients with opioid addiction more than once per month.
• Three-quarters of residents reported that their programs do not provide training in treatment of OUD using buprenorphine.
• Residents scored poorly on survey knowledge questions about treating opioid addiction.
• Residents described limited knowledge about diagnosis and management of opioid addiction as the most important barrier to prescribing buprenorphine followed by a lack of awareness of the medication.
• Residents interested in general medicine and those who cared for patients more frequently with opioid addiction were more likely to be interested in obtaining a buprenorphine waiver.

“Residents in our study overwhelmingly support deregulating buprenorphine for the treatment of OUD,” Shuey said, referencing calls by national addiction experts to remove the waiver requirement to prescribe buprenorphine altogether. “Ultimately, residents are interested in expanding their role in treating opioid addiction but face significant limitations in knowledge, experience, and skills.”

More than 40 states have reported increased deaths from opioids since the COVID-19 pandemic began, underscoring the need to remove barriers to treatment, according to the American Medical Association.

The USF Health Tampa Bay Street Medicine, Hillsborough County and Pioneer Foundation Needle Exchange Program is ready to hit the road as Florida’s second needle exchange or syringe service program (SSP). In conjunction with Tampa General Hospital, the Health, Equality and Linkage Project (HELP) Medical Van will offer to persons who inject drugs (PWID), a safe place to turn in used syringes for clean ones to avoid sharing blood-borne diseases like HIV and Hepatitis C, get anonymously tested for those diseases and be linked to free primary care, wound care, or drug treatment programs among other social services. Targeted locations in Hillsborough County will be those with the highest rates of HIV and opioid overdoses such as around the University Square Mall and downtown Tampa.

Representatives for the USF Health Tampa Bay Street Medicine, Hillsborough County and Pioneer Foundation Needle Exchange Program during a mock run through outside the University Square Mall.

Formed in 2014, Tampa Bay Street Medicine (TBSM) is a USF Health Morsani College of Medicine (MCOM) student-run service organization supervised by faculty that provides medical care to underserved populations. It was initially started to meet the needs of Tampa’s homeless community but continues to evolve as student leaders recognize opportunities to help elsewhere. TBSM students conduct biweekly street runs in unsheltered settings near the I-275 bypass, operate continuity clinics at First Presbyterian Church, and staff a medical van at a variety of clinic sites in partnership with Pioneer Medical Foundation.

USF Health Tampa Bay Street Medicine students talk with a homeless man during a night of biweekly street runs in unsheltered settings near the I-275 bypass. Pre-COVID photo.

“We’re going to the same locations where we’ve built that relationship, where they know that we have providers for primary care and they can trust us already,” said Asa Oxner, MD, FACP, faculty advisor for the USF Health TBSM and vice chair of the USF Health MCOM Department of Internal Medicine. “We have around 800 reoccurring customers in these locations, so we can first start by serving the people we already know well and work on marketing and growth.”

At a PWID’s first visit to the program, they can receive up to 10 clean hypodermic needles and every visit after that, it’s a 1:1 exchange. SSP volunteers will also distribute condoms, alcohol swabs, portable sharps containers and Naloxone (or Narcan), an emergency treatment for narcotic overdose. Pioneer also staffs the Lily Pharmacy free medical clinic inside the University Square Mall, adding another layer of resources along with the other community agencies partnering to offer downstream care for clients who engage in the SSP’s services. Enrollees in the program are tracked with a nickname and an ID number associated with a laminated card they’re asked to carry that identifies them as part of the SSP. If the card holder is arrested for drug paraphernalia, USF providers are working with the local police authorities to have our clients placed in drug rehabilitation instead of jail. At the same time, when PWID carry clean needles and a portable sharps container, it protects the law enforcement and first responders in return.

From inside of the medical van, Jerren Creak, MPH, patient care services research associate for Tampa General Hospital, explains the disease testing options to a mock patient, a member of the community in remission from a substance use disorder, during a mock run through of the needle exchange program.

“In communities where drug users are invited to swap out used needles without retribution, hospitals have reported major declines in the spread of blood-borne infections like hepatitis C and HIV, increased enrollment in drug treatment programs and fewer opioid-related overdose deaths,” said Khary Rigg, PhD, associate professor at the University of South Florida’s Department of Mental Health Law & Policy, in a report from the Tampa Bay Times. “As for the cost, research has shown that every $1 spent on needle exchange programs yields an average $7 savings in avoided costs for HIV-related medical treatment.”

According to the Centers for Disease Control and Prevention, more than 140 Americans die from drug overdoses every day. The U.S. Opioid Epidemic was declared a public health emergency by the United States Department of Health and Human Services (HHS) in 2017. SSPs are a key part of harm reduction strategy, meeting people who use drugs “where they’re at,” and addressing conditions of use along with the use itself. SSPs have been legal in many other states for decades, but it was not legal in Florida until recently. Thanks to the relentless fight for legislative approval and the resulting success of the University of Miami’s IDEA Exchange, a pilot program that was approved in a 2016 exception policy, Governor Ron DeSantis signed into law the Infectious Disease Elimination Act (IDEA) on June 27, 2019.  IDEA allows county commissions to authorize sterile needle and syringe exchange programs for PWID. The law states that disease prevention must be the goal of every exchange program, they cannot use state, county or municipal funds to operate, and they are required to be funded through grants and donations from private resources and funds.

A grant already pays for prescription medications for patients of existing programs operating through partnerships with the University of South Florida, Tampa General Hospital, the Drug Abuse Comprehensive Coordinating Office and Gracepoint, and the SPP will be allowed to use that money to buy the county’s first batch of hypodermic needles and syringes.

With this green light, TBSM and USF faculty began advocating for an SSP in Hillsborough County with the Hillsborough County Commissioner’s Office Opioid Task Force Behavioral Health subcommittee. They used the robust data from Miami’s IDEA Exchange and their program was approved. The needle exchange was supposed to kick off in April but was delayed due to COVID-19.

During a mock run through of the SSP, Heather Henderson, MA, CAS (second from left), USF Applied Medical Anthropology PhD Candidate and director of social medicine programs for Tampa General Hospital, hands a prop to mock patients, members of the community in remission from a substance use disorder, to represent the needle exchange.

In preparation for the official start of the program in December, the USF Health and Pioneer team met in the University Square Mall parking lot with two members of the community in remission from a substance use disorder serving on the SSP advisory board, to do a mock run through and receive their feedback. “This was really great,” said one of the mock patients. “You guys came across that you care and you’re nonjudgmental.”

TBSM will be joined at the needle exchange by USF Health College of Public Health and USF Applied Medical Anthropology students to create a true interprofessional effort to make life better for people in the community. “Preventing acquisition of HIV/HCV requires a complex understanding of the interconnection between biomedical and social dimensions of infectious disease,” said Bernice McCoy, MPH, USF PhD Candidate in Applied Anthropology. “These students will apply both epidemiological and ethnographic methods to contextually assess our SSP’s potential impact and further explore the drug-using habits of PWID. Through this assessment that we can and identify facilitators and barriers towards HIV/HCV risk-reduction within the Tampa Bay community.”

The Opioid Crisis in Florida          

According to the National Institute on Drug Abuse, nearly 68% of the 4,698 reported drug overdose deaths in Florida involved opioids in 2018—a total of 3,189 fatalities (Figure 1).

Figure 1. Number of drug and opioid-involved overdose deaths in Florida. Deaths may have involved more than one substance. Source: CDC WONDER

The increase in substance use has resulted in consequent increases in injection drug use across the country. This has caused not only large increases in overdose deaths, but also the transmission of blood-borne diseases. According to the CDC, the majority of new acute hepatitis C virus (HCV) infections are due to injection drug use and Florida is in the top 10 states with the highest rates of infection. According to the Florida Department of Health HIV/AIDS Surveillance Program, about 7% of the new diagnoses of HIV in Florida in 2018 were from injection drug use (IDU) (Figure 2) and 11% of persons living with an HIV diagnosis were persons who inject drugs (PWID) (Figure 3).

Figure 2. HIV modes of exposure in 2018. Source: National HIV Behavioral Surveillance System (NHBS).

Figure 3. The number of persons who inject drugs (PWID) living with an HIV diagnosis in Florida in 2018. Source: NHBS.

According to the CDC, the HIV burden in Florida is the highest in Broward, Duval, Hillsborough (Figure 4), Miami-Dade, Orange, Palm Beach, and Pinellas. It was announced in the February 2019 State of the Union Address that these counties are a part of 57 jurisdictions that are the focus of the Trump administration’s, “Ending the HIV Epidemic: A Plan for America” or EHE initiative, which aims to end the HIV epidemic in the United States by 2030.

Figure 4. Hillsborough County is one of Florida’s HIV hotspots. Source: NHBS.

The IDEA Exchange

On July 1, 2016, after years of struggling to win legislative approval, Miami-Dade became the first county in Florida with a legal hypodermic needle exchange program and on December 1, 2016, World AIDS Day, the IDEA Exchange opened its doors as a pilot program. The IDEA Exchange in Miami was started by Hansel Tookes, MD, MPH, an assistant professor at the University of Miami’s Miller School of Medicine and principle director of its harm reduction research group. NBC Miami reported in June 2019 that the Miami program has disposed of more than 317,000 used needles since it received temporary authorization from lawmakers in 2016. The program also distributes naloxone and Tookes told the Miami Herald in November 2019 that since March 2017, “the IDEA Exchange has handed out 2,871 boxes of the drug and those who have taken naloxone from the clinic to carry with them have reported 1,529 overdose reversals in that time.” Miami is the only place in Florida seeing a decrease in opioid-related mortality while death tolls spike across the state.

Video by Torie Doll, USF Health Communications & Marketing, with interview footage assistance provided by Ian Vancattenburch, Movie Magic Productions.

USF Health researchers have launched several clinical trials as part of the world-wide effort to reduce the severity and even prevent COVID-19.

In connection with Tampa General Hospital, the USF Health researchers are leading the examination of a range of medications and treatment protocols that could impact the disease at a symptoms-level for patients and at the cellular level of the virus.

“The USF Health Office of Clinical Research and supporting parties are making strides that we’ve never made before,” said Rachel Karlnoski PhD, CHRC, director of Clinical Research Operations for USF Health.

“The typical start-up timeframe for new clinical trials in an academic medical center is 90 days or more. Our goal for COVID-19 trials was five days or less and we have succeeded. Communication, collaboration and prioritization from our budget and contract analysts, onsite legal counsel, USF IRB, central IRBs, investigators, study teams and regulatory manager have enabled our success.”

The united, expedited efforts paid off and now USF Health and TGH are conducting multiple front-line studies that link to larger efforts across the country, all in sync for finding treatments and cures for COVID-19.

“I am humbled by the response from our MCOM research staff, and their willingness to volunteer and put themselves at risk,” Karlnoski said. “We have over 30 volunteers from all departments comprised of nurses, coordinators, regulatory specialists, and data analysts who are ready to be deployed when a COVID trial becomes available. The silver lining behind the pandemic is the visibility it has brought to the importance of clinical research in the advancement of medicine. I am optimistic that we will find an effective treatment.”

One of the main overarching research efforts is the inclusion of data related to COVID-19 as part of a national registry tracking many aspects of the virus and those infected with it, such as pregnant women and their babies. USF Health and TGH providers are actively submitting information to this registry.

Among the clinical trials being set up or currently underway are:

• Testing sarilumab to determine effectiveness in blocking inflammation in the lungs in hospitalized severely ill patients.
• Two studies, one in adults and the other in children, are looking at the emergency use of remdesivir, an antiviral drug that may help kill the virus. These studies are for critically ill COVID-19 patients.
• Several studies looking at hydroxychloroquine, on three main fronts:
  • For severely ill patients: Given to patients coming into the emergency department who are severely ill and are going to be hospitalized.
  • For health care workers: A multi-site clinical trial involving 15,000 health care workers across the country to determine if hydroxychloroquine can prevent COVID-19.
  • For outpatient use: Given to those who test positive for COVID-19 but are not severely ill and don’t need to be hospitalized.
• Using convalescent sera/plasma from people who have recovered from COVID-19 in those who currently have the disease to test the sera’s ability treat these COVID-19.
• Testing 3D printed nasal swabs to confirm their ability to prevent so many false negatives compared with standard swabs when used for testing for COVID-19.
• Testing in outpatient settings the use of inhaled nitric oxide to help treat patients with COVID-19 who require supplemental oxygen.
• Studying Ruxolitinib in critically ill patients with COVID-19 and the impact of the medication in easing or stopping the associated cytokine storm, when the patient’s immune system becomes overwhelmed and attacks healthy cells.
• Other studies are looking into ways for treating pneumonia associated with so many cases of patients with COVID-19; assessing the safety and anti-coronavirus response of combined suppression of host nucleotide synthesis in hospitalized adults with COVID-19; testing Brequinar, an antiviral drug for treating COVID-19.

For more information about these and other clinical research taking place at USF Health, please email the Office of Clinical Research at ocr@usf.edu

The four USF Health physicians who traveled the Bahamas to offer medical help to evacuees from Hurricane Dorian have returned, sharing details about their effort.

Seetha Lakshmi, MD, Andrew Myers, MD, Asa Oxner, MD, and Elimarys Perez-Colon, MD, — all on faculty in the Department of Internal Medicine in the USF Health Morsani College of Medicine – spent several days in Nassau.

Arriving in Nassau to help provide medical care are, from left, Dr. Seetha Lakshmi, Dr. Asa Oxner, Dr. Andrew Myers, and Dr. Elimarys Perez-Colon.

The team evaluated around 50 to 60 pediatric patients for school physicals and acute illnesses.  Patients were about 60 to 70% Haitian living in Abaco and now living in public shelters. Most common ailments were upper respiratory infections, dermatologic diagnoses, asthma, allergies, pneumonia, probable tuberculosis, which was referred to hospital for diagnosis and treatment, and grieving/emotional and psychological trauma.

The trip also included a delivery of 3,000 pounds of medical supplies and medications. This adds to the estimated 50,000 pounds of medical and para-medical humanitarian donations that this group of partners has been able to source and deliver to Rand Memorial Hospital on Grand Bahama over the past two weeks.

Help is still needed to continue the donation effort. Please visit: usf.to/Bahamas

Reactions from the USF Health team:

“We were really surprised by the amount of resiliency we saw because they were evacuee patients, but then they have smiles on their faces and plans for their future,” said Dr. Oxner. “We are also really impressed with how organized the (Bahamas) Ministry of Health is. We’ve participated in other responses in other countries and the Ministry of Health in the Bahamas was much more organized.”

“We offered a lot of help to children who were displaced and trying to get back to school,” said Dr. Lakshmi. “The parents who brought them in just teared up. Another child came in, a four-year-old girl, and she had a rash all over her body and I asked the parent how it started. She said they were in their house when the water started coming up and up. She grabbed her kids and ran up to the hilly area where there was an abandoned truck. She loaded her kids in and she saw the water rise up. They were in chest deep water for 12 hours.”

“In addition to donations, they are going to need more mental health and support,” said Dr. Perez-Colon. “The trauma we witnessed there is very significant. These kids are incredible. They’re resilient. Some were smiling but a lot of them we had a little bit of trouble getting close to them, and some had trouble having eye contact, having nightmares. So they do need more mental health help.”

Dr. Elimarys Perez-Colon with a young girl in Nassau.

Tampa, Fla.  (Oct. 17) — Back from last week’s trip to Puerto Rico, USF Health’s Dr. Asa Oxner discussed her recent experience treating patients and assessing critical medical needs in outlying rural areas of the hurricane-ravaged island.

Dr. Oxner spoke with local news media outside the USF Health Morsani Center for Advanced Healthcare.  She was joined by USF Health Director of Safety and Preparedness Don Mullins, who oversaw the Oct. 11 delivery to Puerto Rico of 1,500 pounds of USF Health-donated medications and supplies aboard a jet chartered by the Tampa Bay Rays for a medical humanitarian mission.

“We saw lots of devastation – power lines cut in half, laying across roads and homes, bridges down and roads full of debris,” Dr. Oxner said.

Dr. Asa Oxner of the USF Health Department of Internal Medicine speaks with local news media about ongoing USF Health disaster relief efforts in Puerto Rico following her return from the island.

Dr. Oxner and Dr. Elimarys Perez-Colon, both assistant professors in the Morsani College of Medicine’s Department of Internal Medicine, spent five days in Puerto Rico working out of hospitals and shelters in devastated rural areas of Puerto Rico.  They also assisted in sorting and delivering supplies and medicine, — including insulin, IV fluids and tubing, and specialized baby formula — donated by USF Health, Tampa General Hospital and other provider partners.

Hospitals in urban areas like San Juan and Ponce where power and water have been restored are rebounding, and most of those critically injured from the hurricane have been treated and are recovering, Dr. Oxner said.

“The long-term health concern is patients with chronic illnesses like heart disease, diabetes and respiratory disorders who cannot access care,” she said.

They live in the central mountainous region of the island hit hardest by the hurricane, and mudslides continue to make many roads difficult to navigate, she added. “They will continue to have shortages in medications for chronic conditions, because the supply chain has been disrupted.”

A dozen cases of leptospirosis, a waterborne bacterial disease, have been reported to the Puerto Rico Department of Health, Dr. Oxner said, adding that the island is also at high risk for diseases like cholera that can emerge after disasters in places with contaminated water.

Dr. Oxner, who spent a year in 2014 helping patients infected with Ebola in Sierra Leone, has always been interested in helping underserved populations impacted by disparities in health care. “Those are the patients I connect with,” she said.

Dr. Oxner is one of 12 Spanish-speaking USF Health doctors, many with disaster experience, who will travel to Puerto Rico over the next two months. She plans to return to Puerto Rico at the end of October.

You can help with USF Health’s relief efforts in Puerto Rico.  Go to the USF Herd Funder site to contribute.

-Photo by Sandra C. Roa, University Communications and Marketing

1,500 pounds of medications and supplies donated by USF Health were delivered Oct. 11 to hurricane-ravaged Puerto Rico on a jet chartered by Tampa Bay Rays for a humanitarian relief effort.

//www.youtube.com/watch?v=Zt5BLxnsftE

Video courtesy of Tampa Bay Rays

USF physicians are now in Puerto Rico donating medical supplies and treating patients severely impacted by Hurricane Maria.

Asa Oxner, MD, assistant professor of Internal Medicine at the USF Health Morsani Collge of Medicine, works without power in Puerto Rico with only the illumination from a head lamp.

Asa Oxner, MD, and Elimarys Perez-Colon, MD, both from the Department of Internal Medicine in the Morsani College of Medicine, landed in San Juan Saturday, Oct. 7. They brought along donated boxes of medications, IV bags and fluids to various hospitals including the Hospital Menonita de Caguas, which is affiliated with the San Juan Bautista Hospital and Medical School.

Drs. Oxner and Perez-Colon traveled to  rural areas to treat patients with diabetes and high blood pressure. They’ve worked in shelters where most patients had their homes destroyed in the hurricane and don’t have the means to travel to hospitals in larger cities.

Dr. Oxner (far left) and Dr. Elimarys Perez-Colon (second from left), a USF hospitalist in internal medicine and pediatrics, are welcomed by officials at Hospital Menonitas Caguas, affiliated with the San Juan Bautista Hospital and Medical School. That’s where majority of the supplies from USF have been dropped off.

On Wednesday Oct. 11, USF Health Director of Safety and Preparedness Don Mullins escorted more than 1,500 pounds of additional supplies and medications donated by USF Health — including insulin, anti-inflammatory medications, IV supplies and baby formula —  aboard a jet chartered by the Tampa Bay Rays for a humanitarian relief mission to Puerto Rico.   The charter jet took off about 9:30 a.m. Wednesday morning carrying tons of medical supplies, food and water from the Tampa-based Course of Action Foundation as well USF Health’s supplies.

Boxes of donated medications and supplies are unloaded on the tarmac in Ponce, Puerto Rico, from a jet chartered by the Tampa Bay Rays for a humanitarian relief mission. The cargo included 1,500 pounds of medications and supplies contributed by USF Health. | Photo by Don Mullins, USF Health

Don Mullins, director of safety and preparedness at USF Health, carries a case of insulin from the airport runway to vans waiting outside the airport to deliver the supplies to hospitals coordinating their distribution.  Mullins escorted USF Health’s delivery and supervised claiming and sorting the boxes. | Photo by Dr. Asa Oxner, USF Health

Dr. Perez-Colon and Dr. Oxner load a chest of refrigerated insulin into a van in Ponce, Puerto Rico. | Photo by Don Mullins, USF Health

Once the flight landed in Ponce, Puerto Rico, Mullins connected with Drs. Oxner and Perez-Colon, to unload and sort the supplies and medications so they could be allocated to outlying rural areas based on need.  The USF Health group also met with representatives from Hospital Menonitas Caguas and San Cristobal Hospitals in Villalba and Juana Diaz municipalities. The two doctors — who spent the last five days in Puerto Rico caring for patients and assessing items critically needed in the outlying rural communities including pediatric nebulizers, prescription baby formula, disposable IV tubes and sterile saline water  —  accompanied Mullins on the flight back to Tampa at 2:30 p.m. the same day.  They plan to make a return trip with more supplies later this month, joined by other doctor colleagues.

Dr. Perez-Colon sorts through the various types of insulin to be delivered for patients in hospitals, shelters and outlying communities. | Photo by Don Mullins, USF Health

A total of 12 USF physicians will travel to Puerto Rico over the next two months to provide additional medical care.  Many have disaster relief experience helping local physicians and hospitals care for victims of earthquakes and disease outbreaks in other countries.

“These folks are our Navy SEALs; they’ve been in Haiti, they’ve helped with Ebola,” Charles Lockwood, MD, senior vice president for USF Health and dean of the Morsani College of Medicine said in an interview with the Tampa Bay Times.  “They know what they are doing.”

Dr. Oxner packs medications and supplies at USF Health before leaving for San Juan, Puerto Rico on Oct. 14. | Photo by Sandra C. Roa, University Communications and Marketing

You can help too! Go to the USF Herd Funder site to contribute.

-Story by Tina Meketa and Anne DeLotto Baier, University Communications and Marketing