Hopes were buoyed this week that a vaccine will soon be available to curb the COVID-19 pandemic. But with the virus spreading rapidly, treatments will remain key in the battle until a vaccine is widely available. Even then, some may refuse it, and a vaccine may not be effective for everyone, especially older people who are at high risk of serious illness and death.
More than 100 treatments to save those infected with the new coronavirus are now being tested or researched, and several experimental therapies have been expedited into clinical trials. Among the latest: The Food and Drug Administration this week granted emergency use authorization for Eli Lilly’s monoclonal antibody treatment, called bamlanivimab, which is designed to help the immune system fight COVID-19.
Dr. Danny Branstetter, medical director of infection prevention at Wellstar Health System, noted the astonishingly accelerated speed of development and pointed to the use of artificial intelligence to help researchers comb through thousands of studies and available compounds and perform genomic sequencing to find and create potential treatments and vaccines.
Most experimental treatments, though, have yet to undergo large-scale testing and trials, and many questions remain about some of the most promising treatments.
Researchers are trying to determine the ideal dosages, the best time to administer treatment during the course of illness, and the best course of action for each patient, such as whether to use a single treatment or a combination of ones. They also don’t know if the treatments are even needed for some patients.
That’s why the key principles of prevention —wearing a mask, social distancing, and keeping hands clean — remain the best tools to help control and stop the spread of the virus, Branstetter said.
“We have at least a familiarity with the virus now, which is good,” he said. “We have a few tools which may have an impact, but we don’t have a universal treatment that is effective for the majority of patients.”
Here’s a look at potential treatments at various stages of research and development.
Remdesivir, originally developed by Gilead Sciences as a treatment for hepatitis C and Ebola, is the first and only experimental drug to be approved by the FDA for treatment of COVID-19.
How it works: Remdesivir stops or interrupts the virus' ability to multiply and infect more cells in the body. Remdesivir is currently administered only intravenously.
What’s the latest: Hospitalized patients who took the experimental antiviral recovered faster than those who took a placebo, according to a report published recently in the New England Journal of Medicine and co-authored by Dr. Aneesh Mehta, associate professor of infectious diseases at the Emory University School of Medicine. The drug’s effects were studied in 103 patients at Emory, a higher number than at any other medical facility involved in the study.
But the benefits were modest. Key findings of the study: Hospitalized patients who received remdesivir recovered in 10 days on average, five days faster than those receiving placebo. Benefits were also seen for patients on supplemental oxygen when they started taking remdesivir. Those patients continued on oxygen for fewer days –—13 days, compared to 21 days for those receiving placebo.
Because remdesivir is an antiviral drug, many experts believe it will likely have more of an effect earlier in the infection when less virus is circulating.
While there have been reports in the past of extremely limited supplies of remdesivir at metro Atlanta hospitals, Gilead Sciences announced it is ramping up production.
Convalescent therapy is a century-old treatment that was used to fight flu and measles outbreaks in the days before vaccines. Convalescent plasma is being used at hospitals in metro Atlanta and around the country as part of a research program run by the Mayo Clinic and sponsored by the federal government.
How it works: When the body encounters a new germ, it makes proteins called antibodies that target the infection. The antibodies float in plasma — the yellowish, liquid part of blood. Plasma therapy works differently than a vaccine. When a person gets a vaccine, their own immune system actively produces antibodies to attack a pathogen. That’s called active immunity. Convalescent therapy offers what’s called “passive” immunity. It “borrows” antibodies from someone who has successfully fought off the disease.
What’s the latest: Convalescent plasma was granted emergency authorization in August and touted by President Trump as a breakthrough, but it has yet to be proven effective and needs more rigorous study, according to experts in Atlanta and across the country.
Larger, randomized clinical trials are underway, but it’s been a challenge to enroll enough participants because some don’t want to possibly receive a placebo instead of the treatment itself. Convalescent therapy is dependent on blood donations, and there have been dire shortages of convalescent plasma during the pandemic.
Hyperimmune globulin is a type of therapy derived from blood plasma of people who have recovered from COVID-19. While the level of antibodies varies in convalescent therapy, hyperimmune globulin offers a standardized dose of antibodies and does not need to be limited to patients with matching blood types.
How it works: Researchers pool various plasma donations and purify and concentrate the antibodies, which could provide a reliable, consistent and more potent level. The treatment would also have a longer shelf life of 24 to 36 months compared with 12 months for convalescent plasma transfusions.
A major research hub for this experimental treatment is in Georgia. Takeda Pharmaceuticals, one of the largest biopharmaceutical firms in the world, has a $2 billion state-of-the-art facility stretching more than 1 million square feet just east of Covington. That facility, which employs about 1,000 people, now has a dedicated space and team of researchers focusing on hyperimmune globulin treatment.
Several other pharmaceutical companies, including competitors such as CSL Behring, teamed up with Takeda to form an alliance, known as the CoVIg Plasma Alliance, to accelerate the development of the therapy. The Georgia facility is manufacturing the potential therapy for the U.S. trials.
What’s the latest: CoVIg Plasma Alliance enrolled its first patient in the Phase III trial last month. It aims to enroll 500 adult patients and hopes to have results by year’s end.
Like convalescent therapy, this therapy relies on willing and able donors.
Monoclonal antibodies. Shortly after President Trump was diagnosed with the coronavirus in October, the White House announced that he had received a dose of Regeneron’s antibody cocktail, putting the spotlight on this little-known drug being tested at several sites in Georgia. On Monday, the FDA granted emergency use authorization to a similar antibody treatment by Eli Lilly.
How it works: Monoclonal antibodies are laboratory-made versions of proteins produced by a person’s immune system in response to invading viruses or other pathogens. Neutralizing antibodies, whether natural or monoclonal, can bind directly to portions of viruses that attach to and enter cells, preventing them from initiating the infection cycle.
What’s the latest: The FDA’s emergency approval was given only for non-hospitalized patients and specifies the treatment is meant for mild and moderate COVID-19 cases in adults and children over 12 who are at high risk of getting worse and requiring hospitalization. That includes people with underlying health conditions such as diabetes, sickle cell disease or obesity, and anyone over 65.
While the safety and effectiveness of this treatment continue to be evaluated, in clinical trials bamlanivimab was shown that it could help COVID-19 patients from getting to the point where they would need hospitalization. The clinical trials also suggest patients would benefit from the treatment early after a positive test result to help kick-start an immune response.
Meanwhile, Wellstar Health System is participating in Regeneron trials, enrolling in-patients and outpatients with COVID-19 and testing it as well as a preventive treatment for people who may have been exposed to the virus by a family member but have not yet tested positive.
The manufacturing of antibody treatments is a complex and costly process that requires specialized expertise and facilities.
Warp Speed provided Regeneron with about $450 million to make up to 300,000 treatment doses, with the first possibly being distributed before year’s end. The federal government also provided Lilly with $375 million for an initial purchase of 300,000 doses of its Monoclonal antibody treatment called bamlanivimab.
Dexamethasone is a powerful steroid that is an anti-inflammatory and can tamp down the immune response.
How it works: It’s believed some of the worst effects of COVID-19 are not from the virus itself but from an exaggerated immune response called a cytokine storm. That can trigger widespread inflammation and lead to organ damage.
What’s the latest: Studies have found that it reduces the risk of death by about 30% for people on ventilators and about 20% for people who needed supplemental oxygen, according to the Mayo Clinic. The National Institutes of Health has recommended this medication for those hospitalized with COVID-19 who are on mechanical ventilators or need supplemental oxygen. The steroid, approved by the FDA in the 1950s, has been used over the years to treat arthritis, allergic reactions and other illnesses. The FDA has given the OK for dexamethasone to be administered, at least temporarily, to severely ill patients.
Dexamethasone is not recommended for less severe COVID-19 infection and could be harmful. Dexamethasone is cheap and widely available.
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