Lacking Science, Doctors Seek a Coronavirus Treatment

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COURT HOUSE – Doctors are faced with decisions on how to treat COVID-19 patients coming into area hospitals, without any clear evidence on a safe and effective drug therapy or a vaccine, which, experts say, could be over a year away.
“You have to take it on a case by case basis. We need more data to be quite honest with you,” Dr. Paras Udani, an infectious disease specialist, said in a phone call with the Herald.
Coronavirus patients are often prescribed a combination of hydroxychloroquine, a drug most commonly used to treat malaria, and azithromycin, an antibiotic. Both drugs are FDA approved for other uses, but there has not been a clinical trial to assess their effectiveness and safety in treating the coronavirus.
In the White House press briefing room last week, President Donald Trump touted the drugs’ potential, saying they show “tremendous promise” and could be a “game changer.”
They are being used by some doctors in local hospitals to treat confirmed cases and even patients awaiting test results who doctors suspect have the virus. Some doctors, however, remain skeptical.  
“There are some studies out there that suggest it may not be of any added benefit,” Udani, the infectious disease specialist for Cape Regional, Shore Medical and AtlantiCare, said.  
In a Rose Garden press briefing March 29, Trump again referenced the two drugs’ potential and said they had been administered together to 1,100 COVID-19 patients in New York City, the epicenter of the disease in the United States. Gov. Andrew Cuomo said these people would be part of a test that would yield results of the drug’s effectiveness.
With limited information and few alternatives, even those skeptical of the drugs’ benefits are forced to consider taking a chance that they could help. The White House remained enthusiastic about the potential.
“I think it’s going to be great,” Trump said last week, adding the government has ordered over a million units of hydroxychloroquine. “We’re quickly studying this drug.”
However, Dr. Anthony Fauci, who stood behind Trump at the briefing, cautioned against being overly optimistic about cases where the drug has shown successful outcomes.
“They may be true, but they’re anecdotal,” Fauci, the director of the National Institute of Allergy and Infectious Diseases, said. “You really want to know definitively if something works, you have got to do the type of trial where you get the good information.”
“There were small arms of studies, out of China in particular, where hydroxychloroquine was given, and not given, and the outcomes were felt to be relatively the same or not significant. There’s a lot of limited data and not a lot of information,” Udani said, adding he is listening to the CDC and leading experts’ opinions to guide his judgment with coronavirus patients.
“The government is giving out important information. However, I think you need to interpret that information as well, which is where I think you need a clinician to do that,” he continued. “When you’re faced with the situation where you don’t have any definitive studies based on a large volume of data that can confirm one way or the other, you base it on what we call expert opinion. In this situation, Dr. Fauci is the expert.”
Asked if there is evidence to prove hydroxychloroquine could be used as a prophylactic treatment for people with COVID-19, Fauci didn’t mince words.
“No. The answer is no,” he said, adding that it would be made available for doctors to use in a setting where there is no proven effective treatment for COVID-19, but that he wanted it available in a way that would allow it to be studied so its efficacy and safety could be proven or disproven.
Trump, though optimistic, differed to the reality of the science.
“I agree with the doctor, what he said. May work, may not work. I feel good about it. That’s all it is just a feeling. I’m a smart guy. I feel good about it and we’re going to see – you’ll see soon enough,” said Trump.
The drugs’ safety profiles are relatively well-known, states the CDC, with main concerns being the risk of cardiotoxicity — such as QT interval prolongation. However, hydroxychloroquine has been reportedly well-tolerated in COVID-19 patients.
Two clinical trials are in the early stages in the United States, according to ClinicalTrials.gov. Both will test hydroxychloroquine versus placebo for its effectiveness in treatment.
One, being run by the University of Minnesota, is currently recruiting. A second, out of Columbia University’s Irving Medical Center, is in an even earlier stage, the national database says.
Numerous other clinical trials are underway in the United States, looking into different options to treat the coronavirus, which originated with an animal-to-human transmission last year in Wuhan, China. The disease was first reported to the World Health Organization by the Chinese government on New Year’s Eve.
Several studies are looking into remdesivir, a new drug. Six other drugs are also being studied in addition to blood transfusions and nitric oxide gas inhalation therapy.
“There’s not really much else to consider right now. The considerations have been hydroxychloroquine, Zithromax (generically known as azithromycin) and concern for the possible benefit of remdesivir. Other than that, I’m not really aware of much else that’s available right now. That’s something we as physicians are staying tuned for,” Udani said. 
Trump said the FDA is allowing new experimental blood therapy for the severely ill, called convalescent plasma, in his Rose Garden address March 29. The process would entail taking blood from people who have successfully recovered from coronavirus and giving it to people who have the disease.
“They’ve recovered, they’re strong. Something was good in them that worked. So we take the plasma from those people who have recovered so well, meaning their plasma is rich in antibodies against the virus,” Trump said, explaining it would then be transfused to those ailing with symptoms of the disease Fauci said, and Trump admitted, could likely kill 100,000 or more Americans.
Until a vaccine or effective drug therapy is discovered, social distancing continues to be at the center of messaging from America’s top doctors and officials, as the country now has more cases of the virus than any other. 
Without these social distancing precautions, which Trump announced will continue through the end of April, the president said the model he was shown put the death toll upwards of 2 million Americans.
To contact Shay Roddy, email sroddy@cmcherald.com.