It almost seems like a Hollywood cliche — a ragtag team of existing drugs team up to defeat a threat that puts the whole world at risk.
The team members? An old malaria treatment dating from the ’40s, a drug combo used against HIV, and a treatment against Ebola that never really took off. The race is on.
In our battle against COVID-19, developing new treatments and vaccines is paramount. But the problem is that these trials usually take years and years, and as much as you accelerate things, it will still take over a year (under optimistic conditions).
This is why researchers are intensely studying already-existing drugs — because we already know they’re safe. It’s also not unreasonable to expect drugs that work for one thing to work for another. There’s no guarantee, of course, but researchers have some good hunches.
Already, word of preliminary results (some of which are optimistic) have made it through the media. Trump’s praise of chloroquine, in particular, ignited hope that this could be, as Trump put it, a “game changer”. But Trump’s statement is premature at best.
In Nigeria, Trump’s statements triggered a frenzy, and three people were hospitalized after ingesting too much chloroquine. Anthony Fauci, the doctor overseeing the COVID-19 outbreak in the US, was quick to correct Trump and say that there is no “evidence” other than “anecdotal evidence” — and when it comes to a treatment, anecdotal evidence doesn’t really cut it.
This is why we need large clinical trials to test these drugs. Of course, speed is essential, but scientific rigor must also be ensured: we need to know that a drug is safe and effective before deploying it.
If we want to find drugs that slow or kill the novel coronavirus, or that can be given prophylactically to protect healthcare workers from the risk of infection, or even to reduce the time necessary in intensive care units, trials like these are our best bets.
So the World Health Organization has announced a large global randomized trial, called SOLIDARITY, to test some of the most promising drugs. The design is not double-blind (so placebo effects cannot be ruled out), but it will be very easy for doctors to enroll patients in the study. When a person is eligible, all the physician needs to do is enter the patient’s data into a WHO website, including any health information that might be a consideration. Then, a consent form will be printed out. This form is scanned and sent to the WHO in any electronic form. The doctors can then mention which drugs are available at their hospital, and the website will randomize the patient on one of the drugs available.
It’s a huge effort made with the goal of being accessible for everyone in the world. Here are the drugs that will be tested:
Chloroquine and hydroxychloroquine
Information about these drugs has been somewhat contradictory. The drugs were designed as treatments for malaria during World War II. It was one of the first promising research avenues against COVID-19, but the WHO had initially planned to leave them out of the SOLIDARITY trial.
However, they changed their mind because the drugs “received significant attention” in many countries, which prompted “the need to examine emerging evidence to inform a decision on its potential role.”
It’s not the first time the drugs were considered for a different purpose, after being tested for dengue and chikungunya — but the results were not encouraging at all. Furthermore, the drugs are also toxic in high quantities.
Much of the support for these two substances comes from a Chinese report on 100 patients, but the data for that study has not yet been revealed. Several studies published in China have been similarly murky. Hopefully, the data will clarify with this trial.
Remdesivir is another promising compound. Initially developed by Gilead Sciences to combat Ebola and related viruses, Remdesivir did not really seem to work against Ebola — but subsequent trials found that it can inhibit the viruses causing SARS and MERS, two other coronaviruses.
There are several anecdotes about COVID-19 patients receiving Remdesivir and making a quick recovery, but again, the data is not clear. Furthermore, Remdesivir is an intravenous drug and it’s pretty expensive — and seems to work best when patients exhibit low levels of symptoms.
This combination drug (sold under the name Kaletra) was sold in the US starting in 2000. Kaletra is used to treat HIV infections.
The drug is generally safe, but can interfere with other drugs. It remains to be seen just how effective it is against COVID-19.
In addition, the SOLIDARITY trial will also analyze the above-mentioned combination, administered alongside interferon-beta: a molecule used for regulating inflammation.
Here, too, safety must be first established, as the combination can cause liver damage.
Overall, the entire trial is very robust and may change along the way as new evidence pops up. Already, multiple countries from all around the world have signed up for it, which is encouraging.
It’s more important than ever to have access to clinical data as early as possible, especially if we want to have a treatment against COVID-19 as soon as possible.