Mississippi on the front lines as COVID-19 vaccine, treatment trials come to Hattiesburg – Clarion Ledger

The world's biggest COVID-19 vaccine test got underway Monday with the first of 30,000 planned volunteers. The experimental vaccine is made by the National Institutes of Health and Moderna Inc. It's one of several candidates in the vaccine race. (July 27) AP Domestic

Enrollment expected to begin in early August of patient referrals from local physicians.

Hattiesburg Clinic is packing a double punch in the fight againstthe coronavirus, which causes the disease COVID-19.

The clinic, with Forrest General Hospital, has joined two nationwide clinical trial programs one for treating seriously ill patientsthrough Mayo Clinic and the other for preventing infection through vaccination with Moderna and the National Institutes of Health.

Leading the treatment program for Hattiesburg Clinic is Dr. John "Bo" Hrom,clinical trial director for oncology for Hattiesburg Clinic and Forrest General.

"This is kind of my wheelhouse," he said. "Since I set up and help run clinical trials, I basically have the experience to do it."

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The other clinical trial, conducted by Dr. Rambod Rouhbakhsh, principal investigator for Hattiesburg Clinic's MediSync Clinical Research, will focus on testing patients who meet certain criteria as part of a larger study by Moderna and the NIHs National Institute of Allergy and Infectious Diseases.

Bonnie Hill, a nurse at a southwest Florida hospital, transfers convalescent plasma from a patient in this Tuesday, April 21, 2020, file photo. The plasma is used to treat seriously ill COVID-19 patients who are participating in the Mayo Clinic's study of convalescent plasma. Hattiesburg Clinic joined the Mayo Clinic program and is treating similar patients in Mississippi.(Photo: Andrew West, The News-Press)

The study is in its third stage, which meansthere has been positive results in the earlier stages and it is time toopen the trial to a larger group of participants who will randomly be given either the vaccine or a placebo to accurately measure the effects of the vaccine and make sure it is safe.

Rouhbakhsh said Hattiesburg Clinic is one of 89 sites in the country taking part in this phase of the vaccine study. He said Hattiesburg Clinic is expected to begin the trial soon.

Hromsaid Mississippi south Mississippi in particular saw an influx of cases early in the pandemic, with many people requiring hospitalization. Medical professionals knew something needed to be done quickly to help patients, but there was no known treatment at the time.

"When the pandemic first started in March, we didn't have any available therapies," Hrom said. "We still have very limited therapies as far as treatment for COVID-19."

Dr. John "Bo" Hrom(Photo: Courtesy of Hattiesburg Clinic)

One of the first programs Hattiesburg Clinic and Forrest General consideredwas Mayo Clinic's convalescent plasma treatment. While the treatment is not FDA approved, the protocol for the program met FDA approval.

"Hattiesburg Clinic was one of the early adopters of the treatment," Hrom said. "When (the pandemic) first started, the hospital and Hattiesburg Clinic administrationtalked about we needed to do something so that we would have a treatment that was available in the hospital.

"This basically came out of the need for treatment. We wanted to do something to have treatment available."

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They joined Mayo Clinic's Expanded Access Program, which allows Hattiesburg Clinic and Forrest General to treat seriously ill COVID-19 patients with convalescent plasma collected from those who have recovered from the coronavirus.

Plasma is the liquid part of blood, Hrom said. A recovered person's plasma contains coronavirus antibodies, which could help neutralize and kill the virus when given to a person who is fighting COVID-19.

So far, Hrom said, more than 100 patients have been treated, with encouraging results. Nationwide there are nearly 2,700 sites participating in the trial with more than 40,000 people treated.

Hrom said the clinic and hospital hope to treat many more patients, but needs plasma donations from those who have recovered from COVID-19 and meet certain criteria.

"It's slow going," he said. "There's not enough recovered patients who have donated."

While Hattiesburg physicians, educators and others worked quickly on creating personal protection equipment, rapid-response testing and other innovations since the onset of the pandemic, treatment and prevention have been slowly evolving but are now gaining steam.

We are very pleased to be involved in the latest phase 3 trial (for the Moderna vaccine), which means our community will have access to this as early as any other community in the world,Rouhbakhsh said.

He said enrollment is expected to begin in early August from patient referrals by Hattiesburg Clinic physicians who know the inclusion and exclusion criteria. A website also will be available for those interested in learning more ormay want to volunteer for the trial.

"But we are going to rely on our doctors to help refer patients,"Rouhbakhsh said.

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Those being considered for the study are people who are at high risk, such as older patients and those who haveco-morbid illnesses, he said.

If it proves to be efficacious with lower side effects, production could be ramped up quickly "to get billions of doses out in the world."

Rouhbakhsh said other doctors at Hattiesburg Clinic will be called on to help him and sub-investigator Dr. Elizabeth Danfordwith the trial on a volunteer basis

"This is such a large trial that is going to rapidly enroll patients, so we are essentially asking doctors to volunteer their off time to participate in this,"Rouhbakhsh said. "Many faculty colleagues have volunteered to be sub-investigators."

He said the goal is to vaccinate around 420, but could getclose to 500 people locally in the next six to seven weeks. Moderna is hoping to have around 30,000 participants nationwide.

In this March 16, 2020, file photo, a person at a Seattle hospital receives a shot in the first-stage safety study clinical trial of a potential vaccine by Moderna for COVID-19, the disease caused by the new coronavirus. Hattiesburg Clinic is joining the study, now in its third stage. According to results released on Tuesday, July 14, 2020, early-stage testing showed the first COVID-19 vaccine tested in the U.S. revved up peoples immune systems the way scientists had hoped. The vaccine is made by the National Institutes of Health and Moderna Inc.(Photo: Ted S. Warren, AP)

Participants would not know if they are receiving theinvestigational medication or a placebo.

The doctors won't either.

Rouhbakhsh said the doctors will follow the patients during length of trial and send the responses to Moderna, along with the other participating sites, so results won't be skewed. A review board also will examine the findings.

If that data is so compelling and it shows that it is so effective, we could potentially end this trial early because it would be unethical to continue with it and deny the placebo group of patients the access to this investigational trial,"Rouhbakhsh said.

That likely wont happen until the early part of 2021 at best,Rouhbakhsh said.

Dr. Rambod Rouhbakhsh(Photo: Courtesy of Hattiesburg Clinic)

Participants who are given the vaccine or placebo will be asked to conduct their lives as usual using the same coronavirus precautions they did before the trial, such as wearing a mask, social distancing and regular hand washing.

"Participants will still need to continue using the same protocols,"Rouhbakhsh said. "Dont go out and be careless and reckless. As scientists,we presume the trial is not going to work and treat participants accordingly."

While the vaccine has already been proven to work, seeing its effectiveness in a larger group of people is another matter. And anumber of participants with the placebo could get COVID-19 during the trial.

"In the United States there are a lot of cases, so the likelihood of getting the illness is quite high,"Rouhbakhsh said.

He said most research is done in bigger cities and in academic settings. The vaccination trial will focus on different size communities

Rouhbakhsh said it is important for the trial to be conducted in communities of all sizes, so Hattiesburg is a prime location since it has qualified experts to conduct the trials.

"We punch above our weight," he said. "We have resources here that are far beyond a city of our size."

To donate, a person must have had a formal COVID-19 diagnosis,be recovered and have no symptoms for 14 days and have a negative COVID-19 RNA swab.

If the person meets the criteria, he or she may go to a blood donation center, such as Vitalant or American Red Cross, where they are hooked up to a machine similar to ones used in traditional blood donations. Donors can give once per week.

"We can get anywhere from two to six units of convalescent plasma at a time," Hrom said."One unit of convalescent plasma is used to treat one patient, so potentially, two to six patients can be treated from one persons donation.

LSUHS will be using serology testing to support the convalescent plasma therapy clinical trial and help identify ideal plasma donors. Shreveport Times

The goal of the trial is to determine if the antibodies developed in a patient who has recovered from the virus will effectively treat those who are currently affected by the disease, Hrom said in a news release.

Only patients in serious, critical condition currently are able to receive convalescent plasma treatment.

While the study is in its infancy, risks associated with receiving treatment are the same as any other blood transfusion. Since plasma is takenat a blood donation center, it meets FDA requirements. Every unit that is donated undergoes various system checks to ensure it is safe.

We needed access to something that would help critically ill patients," Hrom said."If this treatment proves to be beneficial, I want to be able to offer patients the same treatment as those services provided by the Mayo Clinic or Mount Sinai Hospital in New York.

"We want to be able to provide the same level of care as some of these major medical institutions.

Anyone interested in participating in the Convalescent Plasma Clinic Trial may visit hattiesburgclinic.com/convalescent-plasma-trial and fill out the information form provided.

For more information on the COVID-19 Expanded Access Program, visit uscovidplasma.org.

To learn more about the enrollment process for the Coronavirus EfficacyStudy, visit hattiesburgclinic.com/medisync-study-opportunitiesor call 601-544-1866.

To learn more about Moderna and the COVE study, visitinvestors.modernatx.com/news-releases/news-release-details/moderna-announces-phase-3-cove-study-mrna-vaccine-against-covid.

Contact Lici Beveridgeat 601-584-3104 orlbeveridge@gannett.com. Follow her onTwitter@licibevor Facebook atfacebook.com/licibeveridge.

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Mississippi on the front lines as COVID-19 vaccine, treatment trials come to Hattiesburg - Clarion Ledger