TMC opens one of first COVID-19 'antibody infusion' treatment centers in U.S.

Tucson Medical Center and the Department of Health and Human Services on Thursday opened one of two treatment centers in the U.S. where COVID-19 patients can receive a specialized treatment to minimize the severity of illness and prevent some hospitalizations.

The federally funded effort will begin administering monoclonal antibody therapeutic treatments at the temporary center, giving people an infusion of antibodies that are artificially made copies of the antibodies that people produce naturally to fight off infection.

The antibody infusion center will treat patients with mild to moderate symptoms who have tested positive for COVID-19, and are at high risk of severe illness or hospitalization, HHS said. 

Patients at the infusion center will receive one of two monoclonal antibody therapeutics authorized by the U.S. Food and Drug Administration, either one from Eli Lilly and Co., which uses the monoclonal antibody bamlanivimab, or one from Regeneron, which combines the two monoclonal antibodies casirivimab and imdevimab. 

The treatment center arrives just as Arizona struggles with thousands of new coronavirus cases. As the COVID-19 outbreak accelerates in the United States following the holidays, Arizona has the highest rate of new infections per capita over the past week, outstripping every region in the world. Pima County could face 37,000 new COVID-19 infections by the end of the month, officials warned, and local hospitals and funeral homes are running out of space.

On Thursday, Arizona had a seven-day average of 126.4 cases per 100,000 people, accelerating after a lull on Tuesday of 112.1 cases per 100,000, according to data from Johns Hopskins University.

In Arizona, nearly 585,000 people have been sickened by the virus since March, and 9,341 people have died, said state health officials. On Thursday, 297 additional people were reported dead, and the state added 9,913 new cases of infected people. The rate of fatalities in Arizona due to COVID-19 is more than 1 person for every 1,000, state data shows.

“TMC has been on the front line of this pandemic since the beginning and while we have made great progress in our clinical treatment of patients critically ill with COVID, still too many are dying," said Judy Rich, president and CEO of TMC HealthCare. "Monoclonal antibody therapeutics give us an early intervention that can keep people out of the hospital and save lives. Between advances in therapeutics and the vaccine, there is good news on the horizon." 

Dr. Cara Christ, director of the Arizona Department of Health Services, and Pima County Health Director Theresa Cullen praised the effort. 

"The pandemic's impact on our healthcare system demands innovative responses, including ways to employ approved therapeutics to prevent as many severe cases and hospitalizations as possible," Christ said. "We're grateful to the U.S. Department of Health and Human Services and Tucson Medical Center for taking the lead on an effort that holds great promise for our state."

Cullen said that Pima County was "pleased to work" with federal and state officials to help availability of monoclonal antibodies for some patients, and accelerate access to the treatment. This should result in decreased hospitalization rates at a time when Pima County is experiencing significantly decreased ICU bed availability,” Cullen said. 

"Like many areas across the country, Tucson and Pima County are seeing an increase in COVID-19 patients, and many of these patients have become severely ill and need hospitalization," said Dr. Robert Kadlec, the assistant Secretary for preparedness and response at HHS. "We have deployed a federal medical team to the infusion center to provide the therapeutic treatments which can keep people from becoming so sick that they need to be hospitalized, which will help reduce the stress on the hospital, particularly the ICU, and help save lives."

Patients who test positive for COVID-19 and meet the criteria can be referred by their medical provider to receive the infusion treatment, the agency said.  

Monoclonal antibody treatments have been shown to decrease hospitalization rates in people at highest risk for severe disease from COVID-19. This therapy requires an infusion within the first 10 days after diagnosis, the agency said. 

In perhaps the highest-profile case, President Donald Trump received Regeneron’s drug before it was widely authorized after he contracted COVID-19 and was treated at Walter Reed Medical Center. 

In Tucson, patients who have a positive COVID-19 test, and are referred by their doctor, or who receive a positive COVID-19 test at the TMC emergency department can be referred to the infusion center to receive the treatment within that window. 

In November, the FDA issued emergency use authorizations allowing emergency use of two monoclonal antibody therapeutics to treat mild to moderate COVID-19 cases in non-hospitalized patients. Eli Lilly's drug bamlanivimab was  authorized for emergency use on Nov. 9, and Regeneron’s therapeutic was authorized on Nov. 21, HHS said. 

Eli Lilly announced in October that federal officials would buy 300,000 vials of its drug for $375 million, or $1,250 per dose. The initial agreement required the company to deliver the vials over two months, and the U.S. government can purchase another 650,000 vials through June 30, 2021. 

The medicines are given to patients through an IV, and it takes about two hours and a half hours  to treat a patient, who will be treated by medical professionals with the National Disaster Medical System, part of HHS. 

Both medicines can be given to adults and children over 12, who weigh at least 88 pounds. Officials said that the medications will be given to people who have a positive COVID-19 test, and who are "at high risk" for a severe case. 

High-risk adults meet at least one of the following criteria, HHS said:

• Have a body mass index (BMI) of 35 or greater;
• Have chronic kidney disease;
• Have diabetes;
• Have immunosuppressive disease;
• Are currently receiving immunosuppressive treatment;
• Are 65 years of age or older.

The FDA notes that children 12 to 17 can receive the medications under certain conditions:

•  if their body-mass index is high for their age and gender;
• or sickle cell disease;
• congenital, or acquired heart disease;
• some neuro-developmental disorders, including cerebral palsy; 
• a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation; 
• or if they have asthma, a reactive airway, or another chronic respiratory disease that requires daily medication for control.

The federal government has shipped out about 414,195 doses of the monoclonal antibody therapeutics, and allocated about 13,000 doses for patients in Arizona, according to HHS. On Tuesday, the National Institutes of Health announced a large clinical trial that will test how monoclonal antibody therapies can help with people with mild to moderate cases of COVID-19.