Pictured: Dr. Sabine Hazan (standing) and Dr. Brad Barrows, a pathologist on her team at Progenobiome. Photo by Dr. Chris Gilbert.

by Kimberly Rivers

kimberly@vcreporter.com

On Monday, three proposals for clinical trials related to combatting novel coronavirus and COVID-19 were sent to the Institutional Review Board for approval by a Ventura-based genetic sequencing research lab and a clinical trial company.  

“When this virus came on in China, what I paid attention to mostly is that a lot of doctors were dying and that it was spread from asymptomatic carriers — those with no symptoms were still spreading it,” said Dr. Sabine Hazan, a medical doctor board-certified in gastroenterology, internal medicine and hepatology. She has participated in over 150 clinical trials including the first prescription for postpartum depression. Hazan is the CEO and founder of Ventura Clinical Trials and Progenabiome, the company sponsoring the COVID-19 clinical trials.

“Women are on the forefront . . . stepping up to try and save humanity is part of who we are as women, protectors. One of the big problems is being heard.” She said a group of 5,000 female doctors around the world are communicating, tracking data and laying out the pathway to stopping this virus.

As the pandemic approached Ventura County last month she began sounding the alarm to protect “those on the front lines,” especially doctors, nurses and health providers at the highest risk of being exposed to the virus which she says poses new dangers as it mutates.

“It’s time to kill this virus”

In December 2019, Hazan saw the data coming in from China about the virus and the disease —COVID-19 — it caused. “It is extremely dangerous, with a high infection rate.”

A table showing the various genetic mutations of the novel coronavirus as it has moved across the globe. https://www.gisaid.org/epiflu-applications/next-hcov-19-app/

“Successive mutations change both the virulence and transmission of this virus, making it difficult to create a worldwide efficacious vaccine,” explained Hazan. “That’s why we’re expanding our clinical trials to focus urgently on a prophylaxis and treatment protocol for  COVID-19.”

Everyday she’s thinking about the “doctors on the front line. It needs to be created really quickly, we will submit [a proposal] to the FDA as soon as the IRB approves it.”  

Her approach for prevention, however, is not based on a vaccine. Her other trials lay out a plan to test “out of the box” methods of treatment. She can’t say much about the trials now, as they are confidential and she’s not sure when the FDA will respond. “The FDA is slammed right now, I don’t know when we will get an answer.”

What she can say now is that her approach to combatting COVID-19 incorporates various aspects of the pandemic she saw unfolding. Data from China and Italy included startling numbers of doctors getting infected and dying. “Fifteen percent of physicians in Italy are infected. 3.5 percent of them are dying.” She also sees a need for treatment that doesn’t depend on existing prescription drugs, which are becoming hard to get and have side effects. The drug Plaquenil(chloroquine), approved for treating malaria and lupus, is getting harder to get as it is commandeered for treating COVID-19 — despite a lack of peer-reviewed evidence that it works.

When she knew she’d be submitting protocols for clinical trials related to COVID-19, Hazan started making sure her Ventura lab and team would be ready. That meant keeping everything clean and protected.

“Look at what others are doing! In Taiwan… the mortality rate was so low, they basically isolated everyone.” She has ensured that her lab will be an isolated area, and her staff will keep themselves isolated. She has made sure her staff has hazmat suits, goggles and plenty of N95 masks. “Protection is number one…It is part of the oath, first do no harm, ensuring the surrounding area is safe and clean, then we go from there.”

Understand the microbiome

Her expertise in the microbiome within the human body directed her approach to the coronavirus. She thinks success in combating it will be found by “looking at the microbiome in people that are infected.”

“What can I do right now to help humanity? Understand the microbiome of those who survive versus those who die.”

Microbiome in the gut, with a virus invader.

In Hazan’s view, the microbiome in our bodies is key to fighting off illness, including those caused by viruses. Aspects of the novel coronavirus’s structure make it a good fit for the human digestive system and researchers are finding evidence of the virus in fecal matter of those infected, including in the first positive case in the U.S. (1)

“We are all bacteria…those that come from our moms, we pass to our kids. The process of disease creation involves bacteria,” Hazan said.

She’s involved in research that aims to understand the imbalance of the bacteria in patients with Parkinson’s disease, Alzheimers, Crohn’s and others. Her work over the last year and a half taught her to look at the sequencing of viruses and bacteria.

“This virus and it’s ability to mutate makes it difficult to treat. Therefore containment is number one and staying at home is the priority. If you believe you have an emergency first call your doctors, avoid going to the hospital.”

First, listen to the doctors

“Doctors are dying on the front lines. Five doctors in Italy died. University of Washington pathologist: dead from coronavirus. Unless you put doctors in the government level that understand this and talk to the leaders, we are going to lose against the virus. This virus is smart and it has mutated from one country to another.”

“The physicians and scientists need to be heard by the community,”  Hazan continued. “They need to be listened to by the hospitals, the businesses… because we are in a position that we know what we are talking about.” She pointed out many top administrators at local hospitals are not always medical doctors.

“Like on an airplane, you put on your mask first then your child. Same thing here. Doctors need to be protected…I was an early hawk last month in urging a pre-emptive war against COVID-19,” said Hazan. “I saw the dangers when I looked at the changing sequencing of this virus from China to Italy. It’s important to keep looking at the sequencing as the virus mutates, We must also not look back at what could have been done, but we must move forward with a strong plan to keep the front line providers and the patients of the community safe.”

The protocols being recommended by the Centers for Disease Control (CDC) and other authorities call for strict protective measures.

Staying — and surviving — at home

“Look at Hong Kong, a mortality of 40 to 50 people. As soon as they heard China was infected, they closed the borders down, told everyone to stay home.” She emphasized that staying home is the best way to stay well and, if you become sick, to get better.

“People have a 99 percent chance that if they are positive and stay home they will survive,” Hazan stated. 

On March 23 at 4:38 p.m., the Ventura County Sheriff Office issued an “extreme” Emergency Alert emphasizing the “Stay Well at Home Order.” That’s because “asymptomatic people are the carriers. We need to assume that everybody is positive. Because we do not know. We need to start thinking like that,” said Hazan.

She pointed to the R0 of the virus as important for the public to understand when considering the orders to stay home and self-isolate.

“R0” (pronounced “R nought”) is the ratio of how many infections one person will cause under certain circumstances. Imagine under no protocols one infected person goes to work, goes to the grocery store, visits a friend and then goes home. If they came in contact with 25 people and those 25 people then go out and each comes in contact with 25 people, that is 625 infections.

If that first infected person practiced social distancing and stayed home except for, say, a grocery store run, maybe they only infected the checkout person and someone they walked past. That is 623 fewer people infected. That is how you reduce the R0.

Right now COVID-19 has an R0 of 1.4-3.9. The regular seasonal flu strain has an R0 of .9-2.1. The influenza strain that caused the 1918 pandemic was very similar to COVID-19 at 1.4-2.8. Getting that number lower is what bends the curve.

Hazan said that even the process at a drive-through testing site does not protect either the public or the tester. The nurse who swabs one person might get droplets of the virus on their sleeve and/or mask. When the nurse swabs another person, that person could be exposed. 

“Anyone who is feeling ill should call their doctor, only in an emergency do you need to see them. If you have a symptom that’s been chronic, not a good time to go. Acute symptoms, call first, then manage and see what they want you to do,” advised Hazan. “Stay home, let the virus go out of your system for 30 days.”

Hazan’s message is being echoed by healthcare providers across Ventura County and around the United States. A wholly unique concept in modern memory, the community has to come together by staying apart to let the virus pass.

 

  1. https://www.nejm.org/doi/full/10.1056/NEJMoa2001191

 

View the Disaster Plan developed by Dr. Hazan online: www. progenabiome.com/disaster-plan.