MANALAPAN, NJ — Margaret Novins, 53, is currently resting at her Manalapan home after she survived having covid-19/coronavirus.
Novins was discharged Wednesday from CentraState Medical Center in Freehold, where she has been hospitalized for the past ten days. CentraState is the same hospital where four members of one single family, the Fuscos, died of the virus last week.
It's at CentraState where she was given a series of off-label drugs, including remdesivir (a drug originally developed to treat Ebola), Plaquenil (the brand name for the anti-malarial hydroxychloroquine) and azithromycin, an antibiotic with the common brand names Zithromax/Z-Pak. After being given the meds, she said she "turned a corner" fighting the virus.
"I'm not comfortable saying it's that specific drug combo," said Novins. "I was also given an HIV drug, and anti-virals. I think they really don't know yet what works. But I can say the first thing they gave me was the Plaquenil and azithromycin, and I definitely turned a corner at that point."
The chief medical officer at CentraState, Dr. James Matera, confirmed they are giving Plaquenil, remdesivir and azithromycin to "some" covid-19 patients, but stressed that he could not speak to its efficacy, saying more clinical trials on the drugs are needed.
"The problem is we don't have any large-scale control studies to show that this works," said Dr. Matera. "A lot of what we're finding is anecdotal evidence: Some doctors have tried it, and gotten a response. Others tried it and gotten no response. That's the problem with a disease that's so new like this."
When it comes to treating coronavirus, the effectiveness of these drugs remains unknown, and their use is currently described as "compassionate care." However, the federal government gave New York state clearance to start giving a Plaquenil/azithromycin combination to covid-19 patients; Gov. Andrew Cuomo announced the news on Sunday.
Also on Sunday, the World Health Organization approved a groundbreaking "global mega-trial" to see if remdesivir, chloroquine/hydroxychloroquine and an HIV drug combo can effectively fight covid-19, according to Science magazine.
And a lawyer for the Fusco family, backed by local Republican Congressman Chris Smith, is now pushing to allow doctors more leeway in prescribing these experimental drugs, the Asbury Park Press reported today. Currently, doctors have to wait until they get a positive coronavirus test result before they can give the experimentals. Coronavirus test results can take up to five days to get back.
“They don’t have hours, never mind days,” Roseann Fodera, the Fusco family lawyer, told the newspaper.
Novins works as a nurse and her job involves traveling to nursing homes throughout the state of New Jersey, showing the facilities how to use wound-care medical equipment. In fact, that's how she thinks she first contracted coronavirus.
Prior to getting the virus, she was in great health, she says, with no underlying issues, and is a non-smoker.
"Initially, the first few days were relatively mild," she said. "I thought, 'Well, if I do have covid, I'm just going to tough it out.' I confined myself to my room. But then a few days in I started to get concerned."
She wasn't getting better: She was exhausted, had a fever and violent chills that would come on in the evening. It was also very frustrating finding a doctor or hospital that would give her the test to confirm she had the coronavirus.
"I made three separate calls and kept being told, don't come in; go to the ER if you are really sick," she recalled. "But I wasn't ER-sick."
Finally, on Monday, March 16, after a week of getting worse at home, she finally went to the emergency room at CentraState.
"My fever had spiked to 102, then 103 and then 104," she said. "I started having chest pain; it was in my lungs. At that point, I couldn't even stand up."
The slightest effort, talking or moving, left her gasping for air. CentraState admitted her right away, diagnosed her with pneumonia, put her in isolation and tested for the virus. The results came back March 19 confirming exactly what she had known all along: Positive for coronavirus.
"I wasn't in intensive care and I didn't even need oxygen, but I don't think the staff realized how much difficulty I was having," said Novins. "At night I would spike a fever and I could not get warm. I felt so cold I couldn't breathe. It was like when you jump into a cold swimming pool, that shaking and feeling like you can't breathe. If I moved just a little bit, to speak or go to the bathroom, I could not breathe."
"I was not responding to the antibiotics they had given me," she said. "So the next morning I told the infectious disease doctor how much trouble I was having. I told him that my friend had been doing research online and wanted me to ask him about these two drugs: Plaquenil and azithromycin. The doctor responded that he had been fighting for me to get that even before I tested positive."
"Last Thursday I got the positive test result, and that same day I got the pills," she said. "Within 24 hours my fever went away, my breathing got better and I was able to tolerate movement without getting winded."
What these experimental drugs are
Plaquenil (hydroxychloroquine) and chloroquine were originally developed to treat malaria. They bring down inflammation in the body. While chloroquine remains solely for use on malaria patients, Plaquenil is commonly used in the U.S. to treat autoimmune diseases that can cause inflammation, particularly rheumatoid arthritis and lupus. Azithromycin is an antibiotic used to treat bacterial infections. Remdesivir was developed to help fight Ebola; it works by preventing viral cells from duplicating themselves.
When used to treat covid-19, the use of such drugs is considered "off label," meaning they are being used for a purpose other than what the FDA has approved.
Gov. Cuomo even speculated Sunday that existing high usage of the anti-malarials in Africa may be why coronavirus rates are so puzzling low there.
"Some health officials point to Africa, which has a very low infection rate and there's a theory that because they're taking these anti-malaria drugs in Africa, it may actually be one of the reasons why the infection rate is low in Africa," said Cuomo on Sunday, according to ABC. "We don't know, but let's find out and let's find out quickly."
Either way, CentraState doctors are giving this experimental cocktail of drugs to some covid-19 patients.
"I wouldn't say it's a Hail Mary pass, but they are one of the things out there for treatment of this disease," Dr. Matera told Patch Wednesday, the same day Novins was discharged. "There are certain criteria that our doctors will use to determine if the patient is a candidate. It has a lot to do with advanced age and pulmonary issues. Mild cases certainly don't get it. But higher-risk categories, those medications are going to be an option for us."
Right now, CentraState is treating 17 patients who are positive for the coronavirus, and has an additional 22 patients who are not yet confirmed positive, but being treated and isolated as if they are.
Dr. Matera said doctors still aren't sure how or why exactly the experimental drugs work.
"We're not really sure what the mechanism is: There is a large inflammatory response to this virus, and cytokines, which are proteins, are released into the system," he said.
Matera said he plans to do a full review of how many times CentraState has given Plaquenil to covid-19 patients, and how effective it's been.
But in the meantime, covid-19 patients, or their families, are increasingly asking for these experimental/"compassionate care" drugs: A previously healthy 25-year-old Metuchen man with the virus — a college lacrosse star who is now in a medically-induced coma and on a ventilator — has been airlifted to the University of Pennsylvania, where his family is fighting for him to get remdesivir, the Edison-Metuchen Patch reported.
Novins agreed with Dr. Matera's caution, saying she doesn't want the takeaway of this article to be that the experimentals are miracle drugs.
"I know it's controversial and I think they really don't know yet," she said. "I think they are searching for answers."
Congressman wants off-label drugs given out before positive test results come back
Rep. Smith, the Republican congressman who has long represented this part of Monmouth County, wants the Food & Drug Administration to allow doctors to start giving drugs as such as remdesivir before test results come back positive for covid-19.
Currently, doctors have to wait for positive test results.
"The top docs at CentraState told me they couldn’t administer remdesvir without confirmation of the virus," said Smith in an urgent email he sent this week to Dr. Deborah Birx of the White House Coronavirus Task Force. "I urgently write to ask whether new guidance can be issued to permit a physician to administer remdesivir without confirmation of infectiont."
"How many other seriously ill patients have been refused remdesivir because of delays in confirming the virus?," Smith continued. "The tsunami-like number of test samples to be analyzed will likely overcome capacity."