BIRMINGHAM, Ala. (WSFA) - Phase 2 of the most prominent COVID-19 drug trial will explore treatments for some of the most critical cases.
Patient enrollment is now underway for phase 2 of the Remdesivir study, the only drug to receive emergency FDA approval to treat COVID-19. During phase 1, some patients who received Remdesivir had shorter hospital stays and recovered from the virus faster, which quickly elevated the drug as the standard of care for COVID-19.
In phase 2, all participants will receive Remdesivir, half will receive an anti-inflammatory drug used for rheumatoid arthritis and the other half will receive a placebo.
This will help determine whether the anti-inflammatory drug, Baricitinib, could provide better outcomes for patients with declining lung function.
Doctors and preliminary studies indicate some patients' immune systems overreact to the virus causing rapid lung deterioration. Baricitinib, in theory, could scale back an overresponsive immune system, and possibly save patients' lives.
“A significant subset really progresses rapidly to a more severe disease state,” said Dr. Nathanial Erdmann, principal investigator in UAB’s Remdesivir trial. “We believe that much of that is immune mediated, meaning it’s your immune system attacking the virus and mucking up the ability of your lungs to function properly.”
Some physicians believe this runaway immune response could explain why patients of all ages, with or without pre-existing conditions, show signs of marked improvement after having the virus for a week, then take an immediate turn.
“The intent is to provide a strategic brake on the immune system to slow down some of that potential damage,” Erdmann explained. “It inhibits [white blood cells] ability to speak to each other and escalate the immune response."
Erdmann believes using Baricitinib exclusively without an antiviral could advance the disease.
“There’s a concern that if you crank back the immune response but don’t deal with the virus itself, we can allow the virus to get kind of a running start,” he stated. “Even if we improve, so to speak, the immune response, we may lose ground overall. So having both together is, at least in concept, is a more beneficial way of dealing with this.”
Around 1,100 patients hospitalized with COVID-19 will be enrolled in phase 2 of the study. UAB expects to enroll upwards of 20 participants; so far two patients met the criteria and agreed to join the study.
During phase one, Erdmann says the majority of patients and families he approached about the study were highly motivated to participate not only for the sake of their health, but also improving the outcome for those who would contract the virus in the future.
“It speaks to the fact that everyone’s thinking about this and everyone’s looking for more information,” said Erdmann. “Everyone wants this to be handled in the best way possible, but to have it articulated so clearly by some of our participants has been one of the more inspiring things about the study overall.”
This is a double-blinded study, neither the participants nor those conducting the experiments know who was selected to receive the drug or the placebo. An independent data and safety and monitoring board, or DSMB, oversees the study.
Due to the outcome of phase one, the federal government allocated doses of Remdesivir to each state. Alabama received enough to treat more than 200 patients.
Alabama Public Health Officer Dr. Scott Harris confirms each hospital that requested the drug received an allocation and ADPH currently has a small surplus. Harris says the state may receive another small shipment, but what they have on hand must last through the summer. Remdesvir is currently being manufactured and hospitals are expected to be able to order the antiviral through their suppliers in August.