As the number of Coronavirus cases and deaths continues to rise, researchers race at breakneck speed toward some form of a cure – anything to combat COVID-19. To save time during this crisis, the FDA has allowed parts of the standard clinical test process to be neglected. As such, some drugs are already being tried out on people, having skipped the animal phase. While researchers explore new ideas and take every procedural shortcut that can safely be justified, the world is left wondering: What treatments or vaccines may be coming soon?
Chloroquine and the Trump Effect
Chloroquine and its derivative, hydroxychloroquine, have shown promise in the fight against Coronavirus. Initially used to treat malaria, these drugs have since been prescribed to help patients with lupus. Lab tests have shown that this can kill the virus, and some doctors report high recovery rates – but then the president lauded the results. Queue the Trump effect:
“Human beings are not guinea pigs,” tweeted Dr. Eugene Gu, a prominent Trump critic whose activism cost him his job at Vanderbilt University Medical Center after patients refused to allow him to treat them. “We took a solemn oath to ‘first do no harm.’ That means not testing drugs that have deadly side effects without any proven benefit against the coronavirus with no evidence from clinical trials.”
There are risks, according to Dr. Michael J. Ackerman, a genetic cardiologist and director of Mayo Clinic’s Windland Smith Rice Sudden Death Genomics Laboratory. Both drugs could cause sudden cardiac arrest for those with longer than normal intervals between heartbeats – called prolonged QTs. But this is a rare result affecting only a small portion of the population.
“About 90% of us would be absolutely fine being exposed to these medications,” Dr. Ackerman explained. “Five to 10% of us would be at increased risk where I would want my physician to make some adjustments … and 1% of us are at a significantly increased risk of this tragic side effect.” He added that “even if you are in that 1%, that doesn’t mean that sudden cardiac death is around the corner. It just means that your risk has increased enough that there had better be a tremendous amount of respect and awareness given to this QTc issue.”
Repurposed Antivirals: Hit or Miss
The potential repurposing of drugs developed to fight other viruses doesn’t stop with chloroquine. There was some hope that lopinavir and ritonavir, two HIV drugs, would be effective, but the results so far aren’t promising.
Remdesivir was initially used to combat Ebola outbreaks, but it has proven useful against other viruses. Trials are underway in England and Scotland, and both the U.S. and China have already concluded similar tests. Results are expected in the next few weeks. If a drug already approved for use on humans can be used to treat COVID-19, it should significantly speed up the approval process.
A New Way for Donated Blood to Save Lives?
Early reports out of China show that plasma from those who have recovered from Coronavirus can help others fight off the infection. Countries around the world, including the U.S., are now participating in a global program to test whether this can be a viable treatment.
Each donor provides one pint. The red and white blood cells are separated and returned to the donor’s bloodstream, while the plasma – with all its virus-fighting antibodies – is kept. The plasma is tested for the disease, as well as hepatitis, HIV, and others to prevent accidental infection, and then used as a treatment for those suffering from severe cases of COVID-19.
Doctors don’t know whether this will be successful, but it has worked for other illnesses in the past, such as polio, measles, and mumps. However, a lot of blood is required to test the treatment – and if it’s effective, even more will be needed. To further complicate matters, the donor and patient must have the same blood type.
Can a Vaccine Stop COVID-19?
There are currently more than 20 vaccines in development – though the effectiveness of any is far from guaranteed. Even before SARS, MERS, and now COVID-19 made coronaviruses famous, four others in this family affected humans: 229E, NL63, OC43, and HKU1. They’re responsible for somewhere around 20% of all colds, and we still don’t have a vaccine or proven cure for any of them.
Scientists are hopeful about two potential preventatives, however. The mRNA-1273 vaccine is in the human trial phase now. Generally, animal testing would occur first, but in the interest of getting ahead of the virus, the FDA allowed an accelerated testing routine. What’s unique about this option is that it doesn’t contain any actual viral cells and therefore can’t spread the infection. Instead, it is made of messenger RNA from the virus. Hopefully, this will cause the body’s immune system to pump out antibodies in advance, making it better able to fight off the real Coronavirus if exposed.
On another front, researchers from the Murdoch Children’s Research Institute in Australia (MCRI) believe the bacille Calmette-Guerin (BCG) tuberculosis vaccine might offer some protection against COVID-19. TB is caused by a bacterium called Mycobacterium tuberculosis. How can an antibacterial vaccine prevent a viral infection? It’s unclear that it would, or how, but some unexpected benefits may be cause for hope. In addition to proving effective against TB and leprosy, the BCG vaccine has been shown to reduce the risk of some respiratory infections entirely unrelated to tuberculosis. Various studies show that it protects against acute lower respiratory tract infection and sepsis. One study out of Brazil showed that it reduced the risk of pneumonia mortality in children.
Doctors aren’t sure what causes these so-called heterologous effects but suspect it has to do with nonspecific boosting of the immune response. With Coronavirus leading in some cases to the conditions BCG proved effective against, scientists believe the vaccine might reduce the infection rates and lessen the severity of COVID-19. To be clear, this isn’t expected to be the ultimate cure or prevention – but an extra round of defense is nothing to be scoffed at.
Hurry Up and Wait …
When the scientific hurdles have all been cleared, universal application of the solution still won’t be immediate. While dozens of options are being evaluated, most will never pan out – and it’s impossible to predict which, if any, of even the most promising candidates will prove successful. Mass production takes money, and lots of it. Developers simply can’t afford to stockpile a potential treatment or vaccine that isn’t guaranteed to go to market.
Beyond the economic limitations lies the political. Government agencies must approve the distribution of drugs. A nation that develops or discovers a cure might well give its own population first shot at the treatment. Researchers race toward a cure in a hurry up and wait situation. This is the reason behind the 12-18-month estimate floating around; if a breakthrough occurs right now, we’re still looking at the beginning to the middle of 2021 before a vaccine or treatment could be effectively distributed, according to the most optimistic predictions. Even if something like the BCG vaccine – which is already on the WHO’s essential drug list – proves to be the answer today, don’t expect treatment to be widely available tomorrow.
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Read more from James Fite.
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