Could these treatments being studied at NJ hospitals help coronavirus patients?

This is what hope looks like in the time of coronavirus: Family members beg on social media for the release of experimental drugs for their loved ones. President Donald Trump tells the nation of his “gut feeling” that an unproven medication will change the course of coronavirus disease. Top law enforcement officials order pharmacists to guard against hoarding potential treatments by doctors and dentists.  

And at the state's hospitals, doctors study and test drugs in a relentless effort to learn what works with a new disease that so far has no cure. 

No drugs have been approved as specific treatment for the novel coronavirus. There is no vaccine. These two facts feed anxiety in a state where more than 34,000 people had confirmed diagnoses of COVID-19 as of Saturday, and more than 6,000 were hospitalized. Almost 850 people have died.   

Amid the clamor for treatment, a handful of New Jersey hospitals are testing drugs — and soon, blood plasma from recovered patients — through clinical trials to identify effective treatments. Others are using anti-malarial drugs, off-label and outside of studies, in a desperate effort to save critically ill patients. 

Striking the balance between scientific rigor and panic prescribing is difficult.  

Only with data — on dose and effectiveness — will health care providers eventually be able to make evidence-based decisions about treating coronavirus. 

“You don’t really know these drugs work until you study a large group of patients,” said Dr. Adam Jarrett, chief medical officer at Holy Name Medical Center, where studies of two drugs — remdesivir, an anti-viral, and Kevzara, used to moderate immune responses — are underway on some COVID-19 patients. “Some may get better without the drugs.”  

Gov. Phil Murphy said he was optimistic that doctors will have a better understanding of how to treat coronavirus illness by fall, after he spoke with Dr. Anthony Fauci, the nation’s leading infectious disease expert and a member of the White House coronavirus task force, Thursday evening. For now, though, “social distancing is our only vaccine,” Murphy said.   

 Asked about the use of anti-malarial drugs to treat COVID-19, state Health Commissioner Judith Persichilli said: “We’re supporting the studies in New Jersey. The use of these drugs within a clinical study that can give us the specificity we need is a good thing.” 

But “they are not likely to be miracle drugs,” said Dr. Edward Lifshitz, medical director of the communicable disease service at the state health department.  

While two anti-malarial drugs — chloroquine and hydroxychloroquine — are being studied with great interest, “it’s too early to tell for sure” whether they will be effective, he said. Small studies in China and France have provided weak and conflicting evidence.  

“Anything to help at this point is certainly welcome,” he said. 

Unusually high demand for the anti-malarial medicines led New Jersey Attorney General Gurbir Grewal earlier this week to order restrictions placed on prescriptions, lest shortages develop for patients with rheumatoid arthritis or lupus, two conditions for which the drugs are typically prescribed.  

“Stockpiling and hoarding drugs, and inappropriate prescribing for friends and family, is unacceptable,” Grewal said. 

In its severe form, COVID-19 causes acute injury to the lungs. In some patients, this triggers a cytokine storm — an immune response so excessive that the disease-fighting cells, or cytokines, attack the very organs, like the lungs, they are trying to save.  

Some of the therapies being tested aim to moderate that immune response using existing drugs in new ways.  An investigational drug, remdesivir, may interrupt the replication of the virus. And another therapy uses antibodies from patients who’ve fought off the virus and recovered, in an effort to boost the body’s initial response to the virus.  

New Jersey has four clinical trials underway at various hospitals, according to the National Institutes of Health. Here’s what is known about the therapies and where they are being tested in New Jersey. 

Off-label use of chloroquine and hydroxychloroquine 

The vast majority of severely ill COVID-19 patients — 75 to 80% -- at two of the hardest-hit hospitals in New Jersey’s hot zone, Hackensack University Medical Center and Holy Name, receive anti-malarial drugs, and they are in wide use elsewhere.  

These existing drugs can be prescribed for a purpose not indicated on their labels — “off-label use” — because doctors are always permitted to prescribe whatever medications they wish for a patient.    

Chloroquine “has been around for a long time,” said Jarrett, of Holy Name. “We know its safety profile. We give it to patients who have significant disease, where we’ve measured the risk versus benefit.”  

At Hackensack, physicians prescribe hydroxychloroquine, a derivative of chloroquine, for patients with both severe and moderate forms of COVID-19, said Dr. Daniel M. Varga, chief physician executive for the Hackensack Meridian Health system. “Nobody is 100%  sure how it works,” he said. “The supposition is it decreases the amount of viral load somebody has.”  

New York State launched a massive experiment with the drugs last week. State officials have begun to provide the drugs to hospital networks after manufacturers donated millions of doses to the strategic national stockpile and the federal Food and Drug Administration fast-tracked an emergency use authorization. The “observational study” lacks the rigor of comparison against a placebo. It asks doctors to report on mortality, recovery, safety problems, and length of stay in a hospital and on a ventilator.   

Fauci, director of the National Center for Allergy and Infectious Diseases, has cautioned that Americans shouldn’t assume hydroxychloroquine is “a knockout drug,” and that evidence of its benefit is “anecdotal.” Known side effects include heart problems and eye damage.   

Interleukin-6 blockers  

Interleukin-6 is a type of cytokine, a cell that regulates the body’s acute immune response and causes inflammation. Drugs that block it, referred to as IL-6 blockers, have been used in recent years to treat the swollen joints and pain of rheumatoid arthritis. Over-active cytokines cause the cascade of problems that can prove fatal in critically ill COVID patients, so this treatment is being investigated for possible use in such patients.   

Holy Name is participating in a study of one such drug, called Kevzara, produced by Regeneron. Studies launched last month in the United States and Europe are to enroll a total of 400 severe and critically ill patients to see if the intravenous drug reduces their fevers and the need for oxygen. It is a double-blind study: neither patients nor doctors know whether they receive the drug or a placebo.   

Clinicians at Holy Name are optimistic about the results, Jarrett said, even though they must guess at who received the drug.  “It shuts down the body’s immune response to the virus," he said. For severely ill patients, the benefit may outweigh the risk.  

For some patients who don’t qualify for the study, Jarrett said doctors are prescribing related drugs to try to elicit the same response.   

Other hospitals in New Jersey — in Hackensack, Morristown, Newark, Neptune and Edison — also are participating, according to study records with the National Institutes of Health.  

Remdesivir  

An investigational drug with no approved uses anywhere in the world, remdesivir was initially tested as a treatment against Ebola, with disappointing results. Now it is being studied as a potential treatment for COVID-19. It interferes with replication of the virus. 

With limited opportunities to enroll in studies, doctors and patient families deluged the drug’s maker, Gilead, with requests for “compassionate use” of the drug in critically ill patients. At Holy Name, six patients received it on a compassionate-use basis.  

Elsewhere, family and friends of Jack Allard, a 25-year-old lacrosse player who grew up in Ridgewood, were among those who used social media to push for access to it.  But they and others were frustrated in late March, when Gilead halted its compassionate use program, saying it was never meant to handle the volume of requests.  

The company announced instead that it planned to allow broader “expanded access” for groups of patients. In New Jersey, Hackensack Meridian JFK University Medical Center in Edison, The Valley Hospital in Ridgewood and Holy Name will make remdesivir available that way.  

In addition, Hackensack is participating in two clinical trials comparing the outcomes of patients who receive the drug for five days or 10 days, or receive a placebo. One study is for patients who are on ventilators, and the other is for moderately ill, non-ventilator-dependent patients. 

‘Convalescent Plasma’  

Scientists know that the blood of patients who have recovered from COVID-19 is rich with antibodies against the disease. Various experiments around the country seek to extract those antibodies, which are found in blood plasma, and use them to kick-start the immune system in patients who have fallen ill with the disease.  

The timing of the infusion and the extraction of the antibodies are tricky.  

Some New Jersey patients who have recovered have traveled to Mount Sinai Hospital in New York to donate plasma for that institution’s study.  

Hackensack Meridian Health is awaiting the approval of its institutional review board — and a sufficient population of survivors — to launch its own study, Varga said.  

Lindy Washburn is a senior healthcare reporter for NorthJersey.com. To keep up-to-date about how changes in the medical world affect the health of you and your family, please subscribe or activate your digital account today.

Email: washburn@northjersey.com Twitter: @lindywa