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UCI Health Creates New Delivery System For Monoclonal Antibodies In COVID-19 Patients

Monoclonal antibodies are showing promise for improving outcomes for COVID-19 patients, but when a hospital is already beyond capacity, administering them can be a challenge. As hospitalizations soared across California, clinicians with UCI Health created a system for delivering monoclonal antibodies that is keeping hospital beds available for patients with the greatest need.

The hospital bed is one of the most valuable resources that we have, which has been stretched thin by the COVID-19 pandemic. Every effort to expand the number of beds available counts, and that includes being proactive about preventing hospitalizations.”

Dr. Daniel S. Chow, Assistant Professor, Residence, Radiological Sciences, Co-Director, Center for Artificial Intelligence, Diagnostic Medicine

They are partnering with the federal government’s response to COVID-19 to share their success in delivering monoclonal antibodies with healthcare systems across the country.

Despite the increasing availability of COVID-19 vaccines, there is still a critical need to identify, develop and expand the use of therapies for those who have the disease. The FDA provided emergency use authorization for the Eli Lilly and Regeneron monoclonal antibodies in November. The treatment – which uses laboratory-made proteins to block the virus from entering into human cells – is authorized for mild to moderate COVID-19 cases in adults and certain pediatric patients who are at high risk to develop severe symptoms or who may require hospitalization.

However, according to NPR and other news sources, healthcare systems have been slow to adopt this treatment because of the steps involved in administering it. The therapy requires an infusion that takes one hour, followed by an hour of observation before patients are released to self-monitor at home.

As of early February, UCI Health had treated about 170 patients with monoclonal antibody therapy and significantly prevented hospitalizations resulting from severe cases of COVID-19.

As hospitals across the country reach and exceed their ability to accommodate patients due to COVID-19, it is critical that we use every resource to reduce the burden on the healthcare system. When monoclonal therapies are administered appropriately, they have the potential to reduce disease progression and the need for hospitalization, so we are very excited to see success stories like UCI’s.”

Since the therapy is only given to patients who have tested positive for COVID-19, the set-up has to be separated from other patients to avoid spreading the disease. With hospitals at or near full capacity, allocating healthcare workers and a safe, designated infusion space is a challenge.

UCI Health has created a successful system for doing this. They set aside six chairs with dedicated staff in an infusion clinic that allows patients to come in and out of a closed loop system that avoids putting non-COVID patients at risk. Patients who fit the emergency use authorization guidelines are referred to the clinic through their doctors when they test positive for COVID-19. The clinic is capable of infusing 24 to 36 patients with monoclonal antibodies per day.

Using AI technology to aid treatments

UCI is also investigating whether its existing machine-learning tool – which is designed to predict the probability that a COVID-19 patient is likely to need a ventilator or ICU bed – can also identify patients who may benefit from monoclonal antibody treatment. The researchers are incorporating EUA guidelines into the model.

“In combination with EUA recommendations, our tool may help us stratify and identify additional patients who may benefit from monoclonal antibodies,” Chow said.

Of the first 86 patients who received monoclonal antibody therapy at UCI – which included Latino, white, Asian-American and Black patients – only about 3 percent afterward had to be admitted to the emergency department. This tracks with the FDA’s findings that only about 3 percent of high-risk patients treated with the therapy required hospitalization or emergency department visits, compared with 9 percent of patients in the control group.

“If we can avoid ambulatory patients that are symptomatic and COVID-positive from ever having to touch our emergency department or our hospital setting, that helps the community and manages bed flow,” said Dr. Alpesh N. Amin, the Thomas & Mary Cesario Chair of Medicine and the project’s principal investigator.

“The average hospitalization for a COVID patient at UCI is a little over seven days,” added Chow. “So this is actually a very big impact, especially when you consider the associated needs for every hospital day, including nursing and staff needs at a time when personnel are stretched thin, as well as associated medical supplies, etc.”

Using the federal response’s distribution network, UCI Health is sharing their monoclonal antibody delivery system with other healthcare systems. Interested hospitals can reach out to Amin for a consultation.

“Vaccines give us all hope that end of the pandemic is near, but monoclonal antibodies give us ‘more than hope’ because we can now treat high-risk patients with COVID-19 and decrease their risk of becoming hospitalized,” said Col. Deydre Teyhen, deputy program manager for the federal government’s therapeutics response.

(Source: News Medical Life Sciences, 2021)

Roche’s tocilizumab cuts deaths in hospitalised COVID-19 patients: Study

Roche’s arthritis drug tocilizumab cuts the risk of death among patients hospitalised with severe COVID-19, also shortening the time to recovery and reducing the need for mechanical ventilation, results of a large trial showed on Thursday (Feb 11).

The findings – from the RECOVERY trial, which has been testing a range of potential treatments for COVID-19 since March 2020 – should help clear up confusion about whether tocilizumab has any benefit for COVID-19 patients after a slew of recent mixed trial results.

“We now know that the benefits of tocilizumab extend to all COVID patients with low oxygen levels and significant inflammation,” said Peter Horby, a professor of emerging infectious diseases at Oxford University and the joint lead investigator on the RECOVERY trial.

In June last year, the RECOVERY trial found that the cheap and widely available steroid dexamethasone reduced death rates by around a third among the most severely ill COVID-19 patients. That drug has since rapidly became part of standard-of-care recommended for severe patients.

Tocilizumab, sold under the brand name Actemra, is an intravenous anti-inflammatory monoclonal antibody drug used to treat rheumatoid arthritis. It was added to the trial in April 2020 for patients with COVID-19 who required oxygen and had evidence of inflammation.

The study data were from 2,022 COVID-19 patients who were randomly allocated to receive tocilizumab by intravenous infusion and who were compared with 2,094 patients randomly allocated to usual care alone. Researchers said 82 per cent of all patients were taking a systemic steroid such as dexamethasone.

Results showed that treatment with tocilizumab significantly reduced deaths – with 596 (29 per cent) of the patients in the tocilizumab group dying within 28 days, compared with 694 (33 per cent) patients in the usual care group.

This translates to an absolute difference of 4 per cent and means that for every 25 patients treated with tocilizumab, one additional life would be saved, Horby and his co-lead investigator Martin Landray said.

They added that benefits of tocilizumab were clearly seen to be in addition to those of steroids.

“Used in combination, the impact is substantial,” said Landray, who is also an Oxford professor of medicine and epidemiology.

He added that results “clearly show the benefits of tocilizumab and dexamethasone in tackling the worst consequences of COVID-19 – improving survival, shortening hospital stay, and reducing the need for mechanical ventilators.”

Roche’s drug division chief Bill Anderson said last week that previous mixed results were likely due to differences in the type of patients studied, when they were treated, and the endpoint – the juncture at which success or failure is measured.

“We think we’re sort of zooming in on both the most relevant endpoints and relevant patient population,” Anderson said. “It seems like the ideal candidates are patients who are really in that acute phase of inflammatory attack.”

Actemra, along with Sanofi’s similar drug Kevzara, was authorized by Britain’s NHS in early January for COVID-19 patients in intensive care units after preliminary data from a smaller study called REMAP-CAP indicated it could reduce hospital stays by about 10 days.

During 2020, Actemra rose to become Roche’s fifth-best-selling drug, at more than US$3 billion, with nearly US$600 million from COVID-19 treatment.

(Source: Channel News Asia, 2021)