Hospitals here are using the malaria drug hydroxychloroquine with the antibiotic azithromycin to treat advanced COVID-19 cases, but with great caution.

“I used it a couple of hours ago. We tend to, as you do with any medication, weigh the potential pluses and minuses,” said Dr. Stephen Threlkeld, an infectious disease expert caring for COVID-19 patients at Baptist Memorial Hospital-Memphis.

New testing sites announced

“But it gets more complicated when we are talking about therapies for which we have no good data.”

Using hydroxychloroquine and azithromycin for COVID-19 is an off-label use, which means the drugs were intended for other uses and are experimental in treatment for the novel coronavirus now because doctors have few other choices. There also is no COVID-19 vaccine.

Dr. Jon McCullers, infectious disease expert at the University of Tennessee Health Science Center and chief pediatrician at Le Bonheur Children’s Hospital, is no proponent of using hydroxychloroquine, or its derivatives, and azithromycin for people sick with COVID-19.

“We know these drugs are not directly antiviral. They do not inhibit viruses in any way. Hydroxychloroquine will kill malaria, which is a parasite and nothing like a virus,” he said.

In test tube studies in labs, hydroxychloroquine inhibits how the virus reproduces itself, he said, “but it does not translate into mammals.

“It has never been shown to work in previous tests in other viruses in humans (including influenza), and nothing suggests it will against coronavirus in clinical trials.”

Regional One Medical Center is using the hydroxychloroquine-azithromycin combination for patients moderately to severely ill with COVID-19.

“In this case, the decision was to try it. No one has really good data. The data is not convincing one way or the other,” said Dr. Amber Thacker at Regional One.

“It is not a medication without risks. It has been around a long time, but it’s not benign,” she said, adding that no drug is.

Separately, each drug can cause heart arrhythmia because they throw off the heart’s electrical circuitry.

“When you take two of them, the risk is even more,” Thacker said.

Methodist Le Bonheur Healthcare said Wednesday it was restricting the use of hydroxychloroquine, but it did not say how.

Saint Francis Hospital did not respond to requests about its use of the drug.

Tuesday, the Centers for Disease Control eliminated dosage recommendations for hydroxychloroquine in COVID-19 patients. Its website now says only that the drug and other oral medications used to treat malaria are being studied in clinical trials.

On Monday, the American Thoracic Society (ATS) said hydroxychloroquine was acceptable for treating COVID-19 pneumonia under four conditions that must be met simultaneously: The patient is able to take part in the decision; is sick enough to require additional therapy; data is collected, including in control groups; and the drug is not in short supply.

“It’s really important that we have conversations with the patient,” Thacker said. “We say, ‘We don’t know if this will benefit you or not. And there are risks.’

“We normally have more evidence for disease,” she said. “It’s very challenging today. We give educated recommendations, but patients have to make the decision for themselves.”

The use of hydroxychloroquine for coronavirus leaped into public awareness in March after a French researcher, Jean-Marc Rolain, published his study of approved drugs that could be quickly used to fight the pandemic. One was hydroxychloroquine. The study was published in the International Journal of Antimicrobial Chemotherapy in mid-March. He is editor-in-chief.

On April 3, the Antimicrobial Chemotherapy society’s president Andreas Voss issued a letter saying Rolain’s research did not meet the society’s standards.

“Although ISAC recognizes it is important to help the scientific community by publishing new data fast, this cannot be at the cost of reducing scientific scrutiny and best practices,” he said. “Both Editors in Chief of our journals (International Journal of Antimicrobial Agents and Journal of Global Antimicrobial Resistance) are in full agreement.”

In Memphis, McCullers calls it an example of “a craze that got ahead of the data.

“There were no comparison groups, the study was theoretically flawed. Other scientists read it and said it was junk.

“But, it got picked up by the press and President Trump and has gotten magnified out of proportion,” he said.

McCullers agrees with CDC and ATS that hydroxychloroquine merits further testing but says, “It needs to be tested in a realistic way with controls and followed up with data comparing people who are getting it to those who are not.

Calkins: No, there won’t be football

“My suspicion is there will be little difference between these two groups.”

In the meantime, he does not recommend it for anything other than malarial and immunology uses, including for lupus.

“If you have severely ill patients, you will do things just hoping it will work,” he said.

Threlkeld uses hydroxychloroquine for his highest-risk COVID patients at Baptist-Memphis.

“And we tend to use it as early on in the process as we can. It stands to reason that therapies early-on tend to work better. We can see that in influenza. We would expect this to be analogous to that.”

It means weighing the issues “with every single patient,” he said, noting the difficulty with hydroxychloroquine is that benefits that have shown up in small studies are refuted in others.

“There are potentially other things we could use, but they are really difficult to access or not available,” he said.

He knows of cases in Memphis in which physicians prescribe hydroxychloroquine as a COVID preventive. He said he can’t condone it because patients taking the drug need extensive monitoring.

Wednesday, there were 20 COVID patients at Baptist-Memphis; 10 were in the intensive care unit. Of those 10, nine were on ventilators.

Methodist had 25 cases; 15 were in the intensive care unit. Of the 15, 6 were on ventilators.

Regional One said it was reporting the data only to the city and county coronavirus task force.

Saint Francis hospitals did not respond to the questions.

Thacker “honestly can’t say” if hydroxychloroquine has shown positive results in COVID patients at Regional One.

“I don’t think it has caused any harm. But we have not had enough patients. We are trying to collect data worldwide.”

The decision to use it at all at Regional One came only after many conversations, both internally and with UT’s pulmonary and critical care departments, she said.

“The interesting thing is there is new information daily,” she said. “We are busier than we have ever been, and now we also have to read all the time.”