A doctor at the University of New Mexico Hospital has launched clinical trials for multiple drugs that may be useful in treating COVID-19 in patients.
Dr. Michelle Harkins, who is overseeing the trials, said she has been working on the frontlines of the outbreak in the hospital’s intensive care unit.
“I’m a pulmonary critical care physician. I was on call for the first wave of COVID patients that came into the ICU,” Harkins told NM Political Report. Harkins said she began enrolling critically ill patients in the trials who were at the hospital and who agreed to the experimental treatment.
“We’re looking at treating patients with COVID pneumonia that are critically ill. If the patient was able to consent, I presented the information to them that this is an experimental treatment, we don’t know if it’s going to help, but it’s been used worldwide, would you like to participate?” Harkins said. She also spoke with legal representatives for patients who weren’t able to communicate at that time.
“Now, we’re actively enrolling in the ICU,” she said. “We’re trying to do things that can actually help the really critically ill patients to see if we make a difference.”
Limited ebola drug shows promise
One of the trials involves remdesivir, an antiviral that was developed by the firm Gilead Sciences during the Ebola outbreak of 2013-2016 to treat Ebola virus disease.
“It actually is an antiviral, so it inhibits the viral RNA polymerase, meaning it inhibits the virus’ replication,” Harkins said. “There’s a protein that allows the virus to replicate. This particular compound is a nucleotide that inhibits that action and doesn’t allow the virus to replicate itself.”
“That’s in theory how it works,” she added. “Do we know that it’s successful? That’s why we’re doing trials, to see how effective it is in humans.”
Preliminary data from other studies seem promising. Gilead Sciences began experimenting with remdesivir to treat COVID-19 in a laboratory setting in January 2020, which led to a few experimental treatments in both China and the U.S. More data is needed before the drug can be approved for treating COVID-19.
UNM Hospital is now one of a handful of institutions around the world that are conducting trials with the drug. Harkins said she currently has one patient in the hospital that’s being treated with remdesivir. Access to the drug has become an obstacle for expanding the trial.
“We’re still awaiting the expanded access to get the drug for more patients here at UNM,” she said.
The patient on Remdesivir is doing well but is still hospitalized, she added.
Fighting SARS-CoV-2 with antimalarials
The second trial Harkins is conducting uses two antimalarial drugs, chloroquine and hydroxychloroquine. Both were developed to treat malaria, a parasitic disease endemic to tropical regions across the world. Chloroquine is an analog of quinine, the first drug identified to be effective in treating malaria in the early 19th century, though the compound had been used for centuries in Peru to treat fevers.
Chloroquine began being used in the 1930s to treat malaria, but the compound’s toxicity can cause several adverse side effects in patients, including nausea and vomiting, and even blindness in prolonged use; and large doses can lead to death.
Hydroxychloroquine — a form of chloroquine — was developed in the 1940s as a less toxic version of the compound. Hydroxychloroquine is also useful in treating strains of the malaria-causing Plasmodium parasite that have become resistant to chloroquine.
Both drugs also act as antivirals and inhibit viral replication, Harkins said, but they are also used to treat an array of other diseases.
“Hydroxychloroquine is an anti-inflammatory and a mild immunosuppressant. It’s a long standing drug that’s been used for years in patients with lupus to help control the inflammation and the manifestation of the disease,” Harkins said. Chloroquine is also used to treat rheumatoid arthritis.
Studies conducted as early as 2005 found chloroquine and hydroxychloroquine might be useful against other SARS-CoV viruses, including the virus that caused the SARS epidemic in 2003. In February 2020, the first team of researchers at the Chinese Academy of Sciences began exploring the two drugs for treating COVID-19.
The results of that study and others conducted in South Korea and France seem to indicate that the drugs do have some impact on SARS-CoV-2, though more recent data from France’s drug safety agency attributes a number of deaths to experimental hydroxychloroquine treatment.
Last week, the U.S. National Institutes of Health’s National Heart, Lung, and Blood Institute began clinical trials of using hydroxychloroquine to treat COVID-19.
Harkins said her trial, which uses hydroxychloroquine and chloroquine in combination, has been up and running for about ten days.
“Our trials are very similar to the NIH trial for hydroxychloroquine. We’re looking at a similar dosing regimen, making sure there aren’t side effects, and then following the long-term outcome, do the patients clear the virus sooner, do they have decreased lengths of stay, is there a positive effect on symptoms,” she said.
“Part of what hydroxychloroquine does is it inhibits the viral replication. We’re looking to see, does that combination of drugs decrease your viral shedding? Does it actually help the patients have a less severe disease, does it help them get out of the hospital?” she added.
There are currently eight patients at the UNM hospital that are being treated with hydroxychloroquine and chloroquine.
“We had four or five others that were discharged already, that had been on this treatment,” she said, but cautioned that it’s still too early to tell what effect the drugs had on those patients.
“The patients that we’ve had on these drugs have done well, but it’s too early to say. We don’t have a lot of data,” Harkins said. “It’s us looking over time, and what’s being done nationally and in other places, to see how the patients do on the treatment.”
Drug controversy hits home
President Donald Trump touted hydroxychloroquine as being effective at treating COVID-19, despite the lack of conclusive evidence, while both the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have issued emergency authorization and guidelines for the drug’s use in treating COVID-19.
In late March, the FDA gave emergency use authorization (EUA) to use hydroxychloroquine and chloroquine for treating COVID-19, which sparked a wave of criticism from former FDA officials.
The CDC later issued guidance for doctors prescribing chloroquine and hydroxychloroquine for COVID-19, though the document was later edited to remove the guidance on dosage that was based on anecdotal evidence.
In the meantime, the U.S. has seen a wave of inappropriate prescribing of those two drugs among doctors, including here in New Mexico.
The New Mexico Pharmacy Board received two complaints from pharmacists about practitioners inappropriately prescribing the drugs. The New Mexico Regulation and Licensing Department spokesperson Bernice Geiger said the state Pharmacy Board received two emails from health system organizations about prescribing the antimalarials.
“One email was from a chain pharmacy representative who indicated that their pharmacies were reporting prescribers calling in large quantities for family members with no diagnosis,” Geiger told NM Political Report in an email.
The complaints spurred the Pharmacy Board, the state Nursing Board and the New Mexico Medical Board to issue a notice about the complaints and re-affirm the boards’ positions on doctors treating themselves or family members.
“The stance continues to be for practitioners to adhere to evidence based standards of practice in prescribing decisions, and for pharmacists to be aware of current recommendations and indications for the prescribed drug as part of the determination whether to fill such a prescription,” Geiger said.
“The problem lies in prescribing in large quantities, and without an indication for use,” Geiger said. “Stockpiling medication is associated with drug shortages, and individuals who need the drug(s) going without.”
Harkins said the use of hydroxychloroquine and chloroquine for treating COVID-19 is best left to clinical trials.
“When you get emergency access from the FDA, it allows us to treat patients in a trial setting when we don’t have the evidence to know that that’s really what works,” Harkins said. “It’s really better to do it in a trial setting, because we just don’t know, and you want to be able to observe what you’re doing with the patient, and reserve the supply for the patients that have been on it long-term. It’s best to do things in a trial setting to know if we’re making any difference at all.”
Correction: This story referred to malaria as a viral disease; it is a parasitic disease. We regret the error.