The coronavirus pandemic introduced a new virus to the US with no available cure or treatment to help patients.
Due to a rapid increase in cases and deaths, the White House and health officials have raced to find and develop drugs that could curb or mitigate the novel virus in its tracks, but this race has come with warnings about the potential negative effects on patients.
President Donald Trump himself has promoted the potential benefits of using drugs like hydroxychloroquine on Covid-19 positive patients. During one of his daily press briefings last month, he called hydroxychloroquine a “game-changer” despite the Food and Drug Administration (FDA) warning data has yet to conclusively show the drug’s benefits against the virus.
Increased promotion of Covid-19 treatments has also caused shortages for hydroxychloroquine across the US, with doctors being accused of hoarding the medication, which is used on-label to treat malaria and aid lupus sufferers.
The White House has also reportedly considered Avigan, a drug used in other parts of the world to treat the flu, as a potential therapy for Covid-19.
Experts are now working quickly to determine if these drugs work as therapies against the novel virus and help infected patients, as Covid-19 spreads throughout the country.
Previous research from France and China has suggested hydroxychloroquine, a variant of chloroquine first approved in 1955, showed faster clearance of the virus when used for some patients, according to limited studies.
But these studies were done on fewer than 100 people.
Dr David Boulware, an infectious disease expert at the University of Minnesota, and his team received FDA approval last month to launch a series of clinical trials attempting to answer if hydroxychloroquine could prevent and treat symptoms of Covid-19.
The first trial launched on 17 March to determine if hydroxychloroquine could be used as a preventive measure to halt or limit the virus’ impact on the body post-exposure.
“We’re looking at that group and the question of can we give hydroxychloroquine within the first four days post-exposure so we can prevent disease or decrease the severity of this disease,” Dr Boulware told The Independent.
Then a second trial started on 23 March for Covid-19 positive patients or those who showed symptoms for the novel virus.
“We are looking at the question of can we give early therapy to shorten their disease course, decrease hospitalisation, and decrease the severity of the disease,” he said about the second trial. Each clinical trial will include 1,500 volunteers.
Hydroxychloroquine was initially approved by the FDA for treating malaria and aiding symptoms like joint inflammation for lupus patients, so health officials already know the potential positive and negative effects for the drug.
But experts have cautioned the federal government and FDA about promoting hydroxychloroquine for treating Covid-19 before adequate research shows the benefits.
The Mayo Clinic released a warning for healthcare providers last week about the dangers the drug could pose on some patients, which includes it potentially causing sudden cardiac death when taken. The European Commission also announced on Tuesday there was no proof hydroxychloroquine or chloroquine, which is also used for malaria, could treat the coronavirus.
“The efficacy of hydroxychloroquine in the treatment of Covid-19 patients has to date not been proved,” a spokesman for the European Commission said.
But the FDA still approved using hydroxychloroquine on-label for treating Covid-19 on Sunday.
Dr Michael Ackerman, a genetic cardiologist at the Mayo Clinic, told The independent why the Mayo Clinic released its warning about the drug.
“While we are waiting to know the benefits signal, do they work (for Covid-19), I know, as a genetic cardiologist, the potential dark side of these medications,” he said. “There’s a risk of drug-induced long QT syndrome that can lead to drug-induced sudden cardiac death.”
Hydroxychloroquine can block “one of the critical potassium channel proteins in the heart muscle,” Dr Ackerman added. In patients with specific risk factors, the heart can then “spin electrically out of control into a dangerously fast rhythm that could culminate into a drug-induced sudden cardiac death.”
While this occurs in a small margin of the population, Dr Ackerman and other health professionals want prescribers and those taking the drug to be aware of the risks prior to use.
“We’ve got to take care of that at-risk group every bit as much as we need to try to do our best job as healthcare providers to treat those who are experiencing bad coronavirus infections and Covid-19 disease expression,” Dr Ackerman added.
About 90 per cent of patients will experience no negative effects on their hearts from the drug, but the other 10 per cent are at risk to experience changes in their heart rhythm. In about one per cent of the population, this risk could be deadly, the genetic cardiologist said.
Hospitals and doctors are told they must report negative side effects to the FDA that any patient experiences.
Dr Boulware acknowledged the risks relating to hydroxychloroquine and explained the steps his clinical trial was utilising to diminish risks.
“People on heart rhythm medications are excluded from our trial,” he said.
Pairing hydroxychloroquine with the antibiotic azithromycin, which was said could also work to alleviate Covid-19 symptoms, would also not be tested during Dr Boulware’s first two clinical trials to prevent any negative side effects on the heart.
“When you start adding multiple medications like azithromycin, or if you’re on other medications, then it may certainly be more relevant,” Dr Boulware said about the risk factors. “The hydroxychloroquine alone is a very safe medication based on 65 years of use without ever doing.”
Results from the clinical trials are expected within the next month depending on how quickly Dr Boulware and his team can enlist volunteers for the trials.
“I don’t know what the answer is going to be if it does work or doesn’t work but I think regardless of what the answer is it’s an important answer … if it doesn’t work then this is medication we shouldn’t be using in the outpatient setting for prevention or early treatment,” he said. “But if it does work then we should totally be using it and rolling it out.”
Volunteers can participate in the clinical trial from their home after completing a survey on Dr Boulware’s trial’s website to see if they qualify. Medication will then be mailed to the participants’ doorstep.
Already hospitals have prescribed hydroxychloroquine to patients hospitalised from the virus while clinical trials are in the process.
One patient, Suzanne Schwing from New York City, told WABC she thought the drug was what helped her walk out of Columbia Presbyterian Medical Centre after succumbing to the virus. “I don’t know how much of my recovery was due to the cocktail and how much of it was due to the length of the time I was spending recovering, but something certainly shifted,” she said. “And I think it would have shifted a lot later had I not received that particular treatment. That’s my gut feeling.”
The decades-old flu drug was promoted by Japanese Prime Minister Shinzo Abe for its potential benefits. But the drug also comes with negative side effects, such as birth defects.
The White House has asked the FDA to look into emergency authorisation for Avigan, similar to what was allowed for hydroxychloroquine. The White House Security Council has also asked the government to accept a donation of Avigan from Japan, Politico reports.
Avigan was rejected for use in the US by health officials previously, despite its use in places like Japan, because of its risk factors.
But already other countries have shown interest in testing the flu drug on their own patients with Covid-19. Japan’s Chief Cabinet Secretary Yoshihide Suga said during a news conference that about 30 countries have sought Avigan, including Indonesia, Germany, and Turkey.
Indonesia, for example, ordered 2m doses of the drug on 20 March. The interest from other countries will help expand the clinical trial for the drug’s potential benefits, Mr Suga said.
The FDA has not commented on whether it was considering the drug for any future trials to treat Covid-19 patients.
Although drug therapies are an easier treatment to test while scientists work to develop a coronavirus vaccine, billionaire philanthropist Bill Gates, as well as other health officials, have advised the Trump administration to stop pushing miracle drugs publicly before research can back up the potential benefits.