In collaboration with Albert Einstein College of Medicine, Montefiore Health System has started the next stage of the Adaptive COVID-19 Treatment Trial (ACTT). The trial intends to evaluate treatment options for people hospitalized with severe COVID-19 infection. ACTT 2, the new version of the trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health.
Montefiore was the first New York site to join the multicenter trial, which evaluated remdesivir in March. Early results from the trial have shown that coronavirus patients who received remdesivir recovered in 11 days. Compared to an average recovery period of 15 days for patients in the placebo group, the drug's administration proved to give off a statistically significant improvement. Of the 1,063 participants of the remdesivir trial, 91 of them were from Montefiore and Einstein.
Due to remdesivir's promising results, researchers have considered using it inconjunct with baricitinib or placebo in a double-blind, randomized trial. According to Barry Zingman, a professor of medicine at Einstein and clinical director, infectious diseases, at the Moses Division of Montefiore Health System, including baricitinib in the trial could reduce COVID-19-related inflammation.
Furthermore, he says that combining baricitinib with remdesivir may give off an even better treatment option for people severely affected by the disease. Dr. Zingman supervised the original remdesivir study at Montefiore and is currently handling ACTT 2.
Patients enlisted in ACTT 2 have a positive coronavirus infection and lung complications, necessitating a mechanical ventilator's need. All patients in the trial will intevenously receive remdesivir for up to 10 days. Additionally, half of the patients will receive baricitinib through the oral route, with the remaining half receiving an identical placebo for up to 14 days.
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What is Baricitinib?
Baricitinib is primarily used in treating inflammation associated with rheumatoid arthritis. Baricitinib was established by Eli Lilly and Company.
However, researchers are curious to see whether baricitinib combined with remdesivir can prevent or reduce COVID-19's hyper-inflammatory "cytokine storm". This phenomenon can fatally overwork the lungs and other parts of the body when the immune system responds to infection.
In a letter published in The Lancet Infectious Diseases, scientists have described baricitinib's potential to undoubtedly provide an antiviral effect at the approved dose for rheumatoid arthritis therapy. Furthermore, they say that the drug offers an undeniable advantage over other potential inhibitors of the same pathway.
However, they say that the use of baricitinib in susceptible patients with ongoing pneumonia associated with COVID-19 should be considered with extreme caution. Moreover, they say that further studies need to be conducted before concluding that the drug indeed helps patients with coronavirus infections.
Gilead Sciences' Remdesivir
Remdesivir is a broad-spectrum antiviral drug developed by Gilead Sciences. The University of California in San Francisco says that the intravenously-administered drug is known as a nucleoside analog. It mimics a component of viral RNA that the virus uses to replicate itself.
It is one of the leading drugs in the treatment of COVID-19. Early in May, the US Food and Drug Administration issued an emergency use authorization for remdesivir to treat suspected or confirmed COVID-19 cases in adults and children hospitalized with severe disease.
With the drug gaining popularity as it continually shows good results in its trials, people are starting to worry if they could actually afford the highly-valuable medication. Moreover, worries over being able to access the drug also arose as Gilead announced it would end its clinical trials for remdesivir.
