DATE: September 3, 2020
LSU Health Shreveport begins enrollment in Pfizer-sponsored COVID-19 Vaccine Study 

LSU Health Shreveport has begun enrollment in the Pfizer-sponsored COVID-19 vaccine study.  This is a randomized, placebo-controlled trial of an mRNA vaccine to prevent illness due to the SARS-CoV2 virus. The vaccine will be administered by injection. Further details of the study can be found at https://clinicaltrials.gov. 

LSU Health Shreveport discoveries were licensed earlier this year by global biopharma firm BioNTech and serve as a key building block of Pfizer’s mRNA vaccine currently in Phase 2/3 safety and efficacy clinical study.

Adults 18-85 years old who are not pregnant, in good general health and have not been previously diagnosed with COVID-19 can participate in the study once approved by the principal investigator. An assessment on each individuals risk for contracting the COVID-19 includes understanding one’s type of work, lifestyle and all medical conditions.  All those interested in being a part of this vaccine trial should promptly complete the COVID-19 Vaccine Interest Survey. The survey can be found on the LSU Health Shreveport website at lsuhs.edu/coronavirus.

Currently, there are no approved vaccines available to prevent COVID-19. This disease has spread across the world. This COVID-19 vaccine study will enroll up to 30,000 adults, and each person involved plays a powerful role. Joining a clinical trial is an important and personal decision. 

“LSU Health Shreveport is excited to continue our impact on the COVID-19 pandemic by serving as a site for this Pfizer-sponsored vaccine trial. Having our discoveries play a key role in the availability of this worldwide vaccine trial is another example of the strength of our basic science faculty”, stated Dr. G. E. Ghali, Chancellor, LSU Health Shreveport.  

The principal investigator for this vaccine trial is John Vanchiere MD PhD, Professor of Infectious Disease and Pediatrics and a NIH funded researcher.  He is currently serving as the leader of the COVID -19 Strike Team providing testing in 98% of Region 7 nursing homes and in other strategic communities.   
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ABOUT LSU HEALTH SHREVEPORT
LSU Health Shreveport is one of two Health Sciences Centers of the Louisiana State University System and one of only 154 in the nation. LSU Health Shreveport is home to the School of Medicine, School of Graduate Studies and School of Allied Health Professions, and a robust research enterprise. Almost 900 students are enrolled in the degree programs at any one time. Additionally, over 500 residents and fellows are trained each year. The primary mission of the LSU Health Sciences Center at Shreveport is to teach, heal, and discover, in order to advance the well-being of the region and beyond. At the heart of the LSU Health Shreveport is a strong faculty that includes a number of nationally and internationally acclaimed physicians and scientists. More than 600 strong, they lead our research efforts, educate our students and provide primary and specialty care to patients throughout the region. LSU Health Shreveport has strong community support, fostering a culture of diversity and inclusion that promotes mutual respect for all. For more information, visit www.lsuhs.edu. 

CONTACTS:
Lisa Babin, Executive Director of Public Affairs, Communications and Development
Office: (318) 675-8769 | Cell: (318) 458-0166
Email: lbabi6@lsuhsc.edu 
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Date: May 7, 2020.
LSU Health Shreveport is now one of five sites in the world and the first in Louisiana involved in a clinical trial that assesses inhaled nitric oxide as a treatment for patients with mild to moderate cases of COVID-19.

To date, there are no targeted therapeutic treatments for COVID-19 and there are no proven interventions to prevent progression of the disease. This clinical trial in particular will monitor patients with mild to moderate cases of COVID-19 to see how they respond to inhaled nitric oxide as a treatment. Preventing disease progression in spontaneously breathing patients with mild to moderate disease could help to reduce the number of severe cases and deaths, which in turn lessens demand on healthcare resources such a critical care physicians and nurses.

“We are excited to be approved for this early intervention treatment aimed at stopping the progression of the virus which gives patients an improved chance of recovering quickly by preventing the virus from worsening. This treatment will be especially important should we see an increase in the number of COVID-19 positive patients,” said Keith Scott, MD, MSc, FCCM, Professor and the clinical trial’s Principal Investigator at LSU Health Shreveport.

Massachusetts General Hospital reports that preliminary data suggests that inhaled nitric oxide could have a virus-killing effect on COVID-19, due to the genomic similarities between this virus and those that caused the SARS and MERS outbreaks. Studies during the SARS outbreak in 2004-05 demonstrated that nitric oxide was effective in killing that virus.

Patients in the clinical trial will be assigned to a treatment group or a control group. Patients in the treatment group will receive nitric oxide gas along with the standard of care for 30 minutes two times per day for 14 consecutive days. Patients in the control group will not receive the nitric oxide gas. Researchers will be monitoring patients to see if those receiving the nitric oxide gas had a reduced incidence of needing intubation and mechanical ventilation, which is common in patients with severe cases of COVID-19.

Nitric oxide has already been a miracle drug for newborns starved of oxygen by a heart defect due to the gas’s ability to relax blood vessels and the journal Science named nitric oxide the "molecule of the year" in 1992. UCLA pharmacologist Dr. Louis J. Ignarro shared a Nobel Prize in medicine in 1998 for uncovering nitric oxide's role as a "signaling molecule in the cardiovascular system.”

“I can’t tell you how excited I am to see that inhaled Nitric Oxide is being tested for its effectiveness in patients with COVID-19. Having spent twelve years as a Professor in Louisiana, I am very proud that LSU Health Shreveport is conducting yet another clinical trial involving nitric oxide. I applaud these novel efforts to address this viral pandemic,” said Dr. Louis Ignarro, Nobel Prize Winning Scientist, Discoverer of Nitric Oxide, UCLA Emeritus, Ph.D. in Pharmacology.

In humans, nitric oxide is naturally generated by blood vessels and by some brain cells as well. It helps to regulate blood pressure, engulfs invading toxins, and prevents platelets in the blood from forming clots that may be significantly compromised during times of stress including infection thus warranting the need for a supplemental supply. When inflammation, emphysema or a disease like cystic fibrosis attacks the lungs, the large blood vessels and tiny capillaries that deliver oxygen constrict. Inhaled nitric oxide also relaxes those vessels, increasing the transfer of oxygen to the blood and easing the heart's workload.

The Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19 Infection clinical trial was conceived and sponsored by the Department of Anesthesia and the Respiratory Care Services at the Massachusetts General Hospital, which serves as the coordinating center for this international multicenter trial. In addition to LSU Health Shreveport, other collaborators are the University of Alabama at Birmingham, and academic medical centers in Austria and Sweden. For more information about this clinical trial, visit clinicaltrials.gov/ct2/show/NCT04305457.

DATE: April 5, 2020

Critical care and emergency medicine faculty at the LSU Health Shreveport School of Medicine join the Department of Anesthesia at Massachusetts General Hospital (MGH) and the Division of Cardiology in the Department of Medicine at University of Alabama- Birmingham (UAB) as being among the first centers in the US to enroll patients in an international study testing using inhaled nitric oxide to improve outcomes for COVID-19 patients with severely damaged lungs; using gas to effectively “kill” corona virus in the lungs and improve delivery of oxygen to injured tissues. “Inhaled nitric oxide had previously been suggested to decrease original SARS-CoV infectivity over a decade ago but its effect on SARS-CoV2 remains unknown.  Moreover, research from LSU Health Shreveport has shown that nitric oxide is a strong protector against tissue hypoxia, which occurs during severe Covid-1 infection”, said Dr. Chris Kevil, Vice Chancellor for Research at LSU Health Shreveport.

“This is a wonderful collaboration with two highly regarded institutions in the US as well as the sites in Europe.  We have tremendous confidence this therapy will alter the devastating effects of CoVID-19 but we must test it. If results show promise, and since this gas is already FDA approved, wide spread use could begin immediately,” shared Keith Scott MD, MSc, FCCM, Principal Investigator for the nitric oxide clinical trial.  “I am fortunate to have my esteemed colleague Steven Conrad MD, PhD, MS, ME, MBA, MSST, MSC working alongside me on this trial as he brings immense research experience and knowledge in working with critically ill patients.”   

Nitric oxide has already been a miracle drug for newborns starved of oxygen by a heart defect due to the gas’s ability to relax blood vessels, which ultimately led to the resolution of erectile dysfunction as targeted by the drug Viagra. In 1992, the journal Science named nitric oxide "molecule of the year." In addition, in 1998, UCLA pharmacologist Louis J. Ignarro shared a Nobel Prize in medicine for uncovering nitric oxide's role as a "signaling molecule in the cardiovascular system.”

Unlike nitrous oxide (known as laughing gas), nitric oxide has an even brighter future as the colorless, odorless gas, inhaled through a mask or potentially through a small "flute," is now being tested as an experimental treatment for COVID-19. It may also prove helpful in protecting healthcare workers on the front line of the pandemic from getting sick.

In Italy during the COVID-19 outbreak the gas was used under less controlled study conditions; however the treatment appeared to dramatically boost oxygen levels in the blood of COVID-19 patients, said Dr. Lorenzo Berra, the critical-care specialist at Massachusetts General Hospital who is leading the new trial. However, it will take more rigorous testing to clarify how much nitric oxide helps, he said.

A proposed second trial, still under review by a research panel at Massachusetts General Hospital, would enroll healthcare workers who are routinely exposed to patients with COVID-19 and are themselves at high risk of infection. For 10 to 15 minutes at the start and end of every shift, doctors and nurses would tug on a handheld device and inhale a high dose of nitric oxide.

In humans, nitric oxide is naturally generated by blood vessels and by some brain cells as well. It helps to regulate blood pressure, engulfs invading toxins, and prevents platelets in the blood from forming clots that may be significantly compromised during times of stress including infection thus warranting the need for a supplemental supply.

When inflammation, emphysema or a disease like cystic fibrosis attacks the lungs, the large blood vessels and tiny capillaries that deliver oxygen constrict. Inhaled nitric oxide also relaxes those vessels, increasing the transfer of oxygen to the blood and easing the heart's workload.

Physicians who are interested in a patient accessing this clinical trial should send an email to ino_trial@lsuhsc.edu with pertinent patient details. 

Additional COVID-19 clinical trials will be announced soon.

Date: April 4, 2020

At approximately 2:30 p.m., the first convalescent plasma therapy in Louisiana was provided to a critically ill COVID-19 patient at Ochsner LSU Health Shreveport Academic Medical Center. The transfused plasma was donated hours earlier by two people at LifeShare Blood Center in Shreveport. Both individuals who donated plasma at LifeShare are fully recovered from COVID-19.

“LifeShare is among the first centers in the country to partner with regional hospitals to provide this type of therapy for COVID-19 patients”, says LifeShare Medical Director Dr. Tim Peterson.

“The FDA just released new guidelines allowing us to investigationally use convalescent plasma for patients with moderate to severe COVID-19 infections. The only source of this convalescent plasma is donations from people that have recovered for at least two weeks from COVID-19 and have produced antibodies. As cases are expected to peak in the coming week, LifeShare needs additional convalescent donors who are fully recovered from COVID-19. This is an important step in bridging a gap until a suitable vaccine is developed,” stated Dr. G. E. Ghali, Chancellor of LSU Health Shreveport.

This investigative therapy uses convalescent plasma from individuals who have recovered from COVID-19. It is possible convalescent plasma contains antibodies to SARS-CoV-2 (COVID-19) and might be effective against the infection. Use of convalescent plasma has been studied in 

outbreaks of other respiratory infections, including the 2009 H1N1 influenza virus pandemic, 2004 SRS-CoV-1 epidemic, and the 2012 MERS-CoV epidemic.

“With the new LSU Health Shreveport Emerging Viral Threat Lab and its upcoming serology testing platform, we are uniquely able to identify potential convalescent plasma donors in collaboration with LifeShare to produce this potentially life saving therapy,” said Dr. Chris Kevil, Vice Chancellor for Research of LSU Health Shreveport.

Although promising, convalescent plasma has yet to be definitively shown to be effective in COVID-19. In addition to the establishment of clinical trials for convalescent plasma therapy, the Food and Drug Administration (FDA) is working with multiple federal partners and academia to open an expanded access protocol to facilitate access to COVID-19 convalescent plasma. For those not eligible to participate in a randomized clinical trial, access is being made available through participation of acute care facilities in an investigational expanded access protocol.