When people came into the ICU with the coronavirus in March, doctors were hamstrung. As patients faced life-threatening respiratory issues and organ damage, healthcare workers’ only option was to make them as comfortable as possible until they either recovered or died.
“We didn’t have a cure,” Dr. Panagis Galiatsatos, a pulmonary physician at Johns Hopkins Bayview Medical Center, told Business Insider. “We didn’t really have anything other than supportive therapy, which would be giving them oxygen if their oxygen was low, breathing devices if they were struggling to breathe, fluids if they were dehydrated. That was it.”
But treating those patients is getting easier now that a few therapies have been approved for severe cases, he said.
For the sickest individuals, doctors can prescribe dexamethasone, a cheap, generic steroid that’s been shown to significantly reduce mortality among critically ill COVID-19 patients. A recent analysis from the World Health Organization found that corticosteroids in general may lower mortality rates among these patients.
For those who don’t require breathing machines, doctors have two FDA-authorized options: the repurposed Ebola treatment remdesivir, and convalescent plasma (blood infusions from recovered patients).
“We’ve gotten really good at knowing when to pull the trigger for those,” Galiatsatos said.
Researchers are still looking to add more tools to that arsenal — particularly when it comes to treating less severe cases. Hundreds of experimental COVID-19 therapies are being developed and tested. This month in particular has yielded a spate of promising results in two areas: new antibody drugs and repurposed rheumatoid arthritis treatments.
One antibody medication, from pharma giant Eli Lilly, was found to lower the chances that a COVID-19 patient will require hospitalization. Another, from the biotech company Regeneron, entered a critical trial last week.
The rheumatoid arthritis drugs gaining attention, meanwhile, come from Eli Lilly and Swiss drug company Roche. Eli Lilly’s drug, baricitinib, was found to reduce recovery times among COVID-19 patients when combined with remdesivir. Roche’s therapy, Actemra, seemed to reduce the need for ventilators.
But some of this data still needs review from independent experts, and drugs like Actemra have failed in the past when administered to hospitalized COVID-19 patients. So more research is needed before companies can seek emergency approval from the FDA.
Here’s what to know about the newest developments in the race for COVID-19 treatments.
Eli Lilly’s antibody drug may reduce the risk of hospitalization
University of Maryland School of Medicine/AP Photo
Neutralizing antibodies are our body’s natural response to a foreign pathogen. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has called them “the gold standard of protection against a viral infection.”
To make an antibody therapeutic, scientists hunt for the most potent antibodies among a large pool, then clone and produce those antibodies at scale.
Eli Lilly began testing its antibody drug, LY-CoV555, on patients in June. That same month, the drug entered a phase 2 trial among people with mild to moderate cases of COVID-19.
The company announced the preliminary results last week: Out of more than 450 newly diagnosed patients, only 1.7% of those who received the drug were hospitalized, compared to 6% of patients who got a placebo. That’s a 72% lower risk of hospitalization.
“Since these are the first clinical data we’ve seen from neutralizing antibodies, I find the results quite encouraging,” Eric Topol, a cardiologist who directs the Scripps Research Translational Institute, told Science Magazine.
This class of antibody drugs, he added, “represents our best shot for a near-term, potent intervention even though they are difficult to produce at scale and will likely carry a high cost.”
There are still reasons to be skeptical, however. The results haven’t been vetted yet by independent scientists or published in a peer-reviewed journal. Eli Lilly also hasn’t confirmed whether they were statistically significant.
It’s possible that the researchers just got lucky, since one dose — 2,800 mg — was found to significantly reduce the viral load in patients’ blood after 11 days, but the higher dose — 7,000 mg — did not. Eli Lilly said that could be because most patients had completely cleared the virus by day 11, however.
The phase 2 trial is still ongoing: Eli Lilly hopes to enroll 800 participants in total.
Regeneron’s drug just entered a major clinical trial
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Regeneron started clinical trials for REGN-COV2, its two-antibody cocktail, in June. The company expects to have initial data by the end of this month, but the early results seem favorable: Among the first 30 participants — which include hospitalized and non-hospitalized patients — the intravenous drug appeared to be safe. It has also been shown to prevent and treat COVID-19 in animals.
The antibody cocktail has demonstrated enough potential, in fact, to be included in one of the world’s largest randomized clinical trials of potential COVID-19 treatments: the Recovery trial led by the University of Oxford.
“The Recovery trial was specifically designed so that when promising investigational drugs such as REGN-COV2 became available, they can be tested quickly,” Peter Horby, the trial’s chief investigator, said in a statement last week. “We are looking forward to seeing whether REGN-COV2 is safe and effective in the context of a large-scale randomized clinical trial.”
Actemra reduced the need for breathing machines
Getty Images/Joe Raedle
Scientists have a few theories about why some coronavirus patients make a rapid turn for the worse. One is that an aggressive immune response leads the body to attack its own cells — what’s known as “cytokine storm.” Cytokines are small proteins that can trigger immune activity and inflammation in the body.
Roche’s anti-inflammatory drug Actemra targets a key cytokine called interleukin-6. Studies have observed increased levels of interleukin-6 among critically ill COVID-19 patients, and significantly higher levels in severe cases than mild ones.
Actemra did not reduce mortality among hospitalized COVID-19 patients in a phase 3 trial that ended in July. But on Friday, Roche announced that the drug was found to reduce the need for breathing machines in a new study of hospitalized patients.
Over 28 days, only 12% of patients who received the intravenous drug required a breathing machine, compared to 19% of patients who got a placebo.
About 85% of the nearly 390 participants in the study were Hispanic, Black, Native American, or identified with another ethnic or racial minority group. That makes the trial the first global, phase 3 clinical study of a COVID-19 treatment that enrolled mostly minority patients.
Eli Lilly is also repurposing a rheumatoid arthritis drug
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Eli Lilly’s baricitinib — known commercially as Olumiant — is already approved to treat adults with moderate to severe rheumatoid arthritis. It belongs to a class of anti-inflammatory drugs called Janus kinase (JAK) inhibitors, which help calm cytokine storms.
The drug, administered in pill form, is showing early promise as a COVID-19 treatment when combined with remdesivir.
The combo entered a phase 3 trial in May that involves more than 1,000 hospitalized COVID-19 patients. Last week, Eli Lilly announced that together, Olumiant and remdesivir reduced patients’ average recovery time by one day compared to patients who only received remdesivir.
The results put the company one step closer to seeking emergency authorization from the FDA.
A WHO analysis found steroids could lower mortality
Reuters
US treatment guidelines already recommend giving the corticosteroid dexamethasone to patients who are on ventilators or need oxygen support.
A major UK clinical trial found in June that dexamethasone reduced the number of deaths by one-third for people on ventilators, and by 20% among patients who were getting extra oxygen. More recently, a Brazilian study found that patients who took dexamethasone spent fewer days on a ventilator.
Research suggests other corticosteroids could be effective, too.
A WHO working group analyzed seven randomized trials of corticosteroids that in total involved more than 1,700 critically ill COVID-19 patients. Some received dexamethasone, while others received hydrocortisone or methylprednisolone. Overall, the researchers found fewer deaths among patients who received the steroids relative to those who received standard care or a placebo.
That led the WHO to issue a “strong recommendation” for the use of steroids earlier this month.
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