Debate over over the drug chloroquine is racing across the country almost as fast as COVID-19 itself.
The success of the drug — first approved for medical use in the United States in 1955 as a treatment for malaria and now also for rheumatoid arthritis and lupus — is being debated from the White House all the way to hospital rooms.
The use of chloroquine, which became politically charged when President Donald Trump endorsed its possibilities in March, has been approved by the FDA for emergency usage for COVID-19 patients, even as clinical trials of it and other drugs continue around the world.
Trump called the drug a possible “game-changer” in the fight against the COVID-19 pandemic, prompting critics to accuse him of pushing for unproven, untested remedies.
At the same press conference, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said any success is anecdotal.
“It was not done in a controlled clinical trial. So you really can’t make any definitive statement about it,” Fauci said.
And yet:
— A recent international poll of thousands of doctors from around the world rated chloroquine as the best treatment for coronavirus, according to a story in the New York Post.
— A 104-year-old World War II veteran in Oregon became the oldest person thus far to survive COVID-19 after being treated with chloroquine and a common antibiotic called azithromycin. “I did it to give him a fighting chance,” Dr. Rob Richardson told reporters.
— Hospitals across Connecticut have begun using chloroquine to treat COVID-19 patients. “We are using [the drug] out of desperation because we do not have anything else to use,” said Dr. Henry Anyimadu.
— Hospitals in the San Francisco Bay area are now administering the combination of chloroquine and azithromycin to any COVID-19 patients admitted to the facilities.
So what is happening with treatments in north central Ohio?
OhioHealth Mansfield Hospital and OhioHealth Shelby Hospital
“OhioHealth constantly evaluates the scientific literature being published related to hydroxychloroquine and its possible role in therapy for moderate to severe COVID-19. We do have access to the medication; however, the evidence to support its use is very limited and anecdotal,” said Caroline Cruce Jozefczyk, PharmD, BCIDP, an antimicrobial stewardship pharmacist.
Jozefczyk said some test tube studies of chloroquine show activity of the drug against COVID-19.
“So, in addition to its well known ability to reduce inflammation there is a potential for antiviral activity,” she said.
She said there are many clinical trials ongoing into chloroquine in the treatment of the coronavirus.
“These trials can take weeks to months to complete. The Food and Drug Administration (FDA) then must evaluate the data from those studies for safety and efficacy to determine if the medication can be approved for usage in COVID-19 cases,” she said.
There are also short-term side affects with chloroquine that physicians and patients must be aware of.
“Short term side effects – which is what we are concerned with during the shorter treatment durations proposed for COVID-19 – include gastrointestinal disturbances, cardiac arrhythmias, low blood sugar, and muscle spasms. Specifically, the risk for cardiac arrhythmias pose the greatest concern when people are taking this medication without close monitoring by a physician who is familiar with the patient’s past medical history,” she said.
“It is understandable that people want to know if there is something out there that can definitively treat this virus. However, we must exercise caution and evaluate reports of treatments being used all over the world for safety and efficacy in order to best protect and take care of our patients,” Jozefczyk said.
University Hospitals Samaritan Medical Center in Ashland
Dr. Aaron Young, medical director of critical care and ICU with University Hospitals Samaritan in Ashland, said some hospitals within the system have used chloroquine.
“We have not used it in Ashland,” he said. “We are using other drugs. University Hospitals are part of a clinical trial for remdesivir and we are part of that in Ashland. We are also using some of the HIV drugs, which seem to be showing good activity against this virus. We have chloroquine on hand and we’re ready to use it if needed.”
Remdesivir is an antiviral compound undergoing clinical trials in China, the United States, and the United Kingdom as a potential treatment for COVID-19.
Young said the key to any drug treatment is to reduce the “viral load” in the patient, allowing the body to better combat the virus. Still, doctors are learning daily.
“We’re at a very new time in medicine for all of us,” he said. “We are at a place where we don’t know all the right answers yet.”
Young said local doctors are aware of chloroquine and azithromycin being used in combination.
“It seems like when you add those two drugs together, you can get the viral load down faster,” he said, acknowledging trials are ongoing and success stories are largely anecdotal.
Young said he is not surprised anxious people are looking for drugs like chloroquine and others to calm their fears.
“We all want the answer, I think,” Young said. “We are all searching really hard to find that answer.
“There are some other things (also) going on. One small study shows that taking the plasma from someone who went through the disease, getting those antibodies, may help others with the disease.
“We have the ability to get through this. That’s been the motto of medicine since the start of time — figure out how to fix things.”
Avita Health System in Ontario, Galion and Bucyrus
“There is little direct evidence to inform management of COVID-19. Prevailing medical sentiment is that clinical trials are urgently needed to effectively guide management. However, most patients do not have access to clinical trials. Trials take time, and speculation is that results will not be available until late spring or early fall,” said Dr. James Heddleson, a fellowship-trained pulmonary and critical care physician, as well as the medical director of inpatient services at Avita Health System and chief of staff.
“As a result, institutions and clinicians on the front-line are utilizing a variety of approaches to manage COVID-19 patients outside of a clinical trial, ranging from supportive care alone to prescribing unproven medications like Hydroxychloroquine, among many others currently under investigation. Based upon the severity of illness associated with COVID-19 infection, physicians at Avita may consider Hydroxychloroquine use on a case-by-case basis.”
Heddleson said physicians are not yet sure how chloroquine might work to assist in the fight against the virus.
“Various theories have been postulated that range from inhibition of virus replication to immune system modulation. However, there is no formal scientific evidence to date to support these theories. Studies of Hydroxychloroquine are ongoing around the world at present to determine its efficacy against COVID-19,” he said.
Heddleson said there is no time frame for when the FDA may fully approve chloroquine for usage against COVID-19.
“Hydroxychloroquine does not have a clinical indication for treatment for COVID-19 by the FDA. Its use for treatment of COVID-19 is ‘off-label’. The time frame for FDA approval is unknown as this declaration would be based upon data from clinical trials which are currently ongoing,” he said.
Heddleson said many medications approved for specific diseases are then found to be effective in the treatment of other ailments.
“The most recent being Sildenafil (trade name Viagra) – which was developed for treatment of heart failure. Through clinical trials and analysis in patients with heart failure, the drug was found to demonstrate a benefit in another condition, erectile dysfunction.
“Similarly, Hydroxychloroquine (or a number of other current medications under investigation vs COVID-19) may demonstrate clinical efficacy against a disease state that it was not initially designed to treat. To date, several medications or combinations of medications ‘show promise’ anecdotally against COVID-19. Ultimately, these medications need to prove themselves objectively though clinical data obtained via randomized control trials in order to obtain clinical indications from the FDA for widespread use.”
