A clinical official with AstraZeneca, the multinational biopharmaceutical company, tells Provider that progress in developing a potential COVID-19 treatment that complements the vaccine program will require a partnership with long term and post-acute care facilities and individual residents.

As part of the broad effort to treat the coronavirus, AstraZeneca has partnered with the U.S. government to develop a long-acting antibody combination (LAAB), called AZD7442. An effective monoclonal antibody (man-made versions of human antibodies in the immune system) that can prevent COVID-19, particularly one that is long-lasting and delivered by intramuscular injection, may be of particular use in certain groups, the company said.

This includes people who have compromised immune function, those who are over 60 years old, and people undergoing medical treatments that may preclude them from receiving a COVID-19 vaccine, according to federal health guidance.

Robert Gasser Jr., MD, senior director, clinical development, AstraZeneca, says the drug maker has high hopes for AZD7442 as a potential preventative treatment, but “we need to test this investigational product on the people who are most likely to benefit from its use,” including those residing in nursing homes and similar facilities.

“It is insufficient to test on young and healthy people,” Gasser says. If the monoclonal antibodies are to be successful, the trials will need to focus on high-risk individuals including the elderly, he says.

The elderly are at high risk of both being infected and then seeing the most severe results from the SARS-CoV-2 virus that causes COVID-19. Gasser says while there is much discussion about a vaccine for COVID-19, including recent positive news from AstraZeneca on this front, the antibody treatment is very much needed in order to fill in the gaps for those who cannot benefit from a vaccine and to have a treatment option for those who are exposed or infected despite the presence of a vaccine.

“We think that vaccines will be a major preventive public health measure to control the pandemic, but people won’t be immediately protected,” Gasser says. Two doses will be required for most of the vaccine candidates. “This means four to six weeks to be protected, which in many situations may not be quick enough, like for those living in a skilled nursing facility where another resident or member of the staff is shedding the virus, making exposure immediate.”

In addition, vaccines are dependent on the ability of a person getting it to be able to mount an effective immune response. “This is a common reason why vaccines are not always entirely helpful for the elderly, especially if they have illnesses like kidney disease, if they are on certain medications, are obese, or have certain other medical problems.  The nature of nursing homes is such that the vast proportion of their resident population is elderly and may have comorbid conditions that result in a poor vaccine response,” he says.

To have an additional preventive treatment at hand then is very important for the long term care setting, and thus leads to the AstraZeneca call for facilities to respond. Gasser says if a facility participates, there are further steps leading to getting the permission of individual residents to take part. The treatment trial is a blinded one, meaning that the person getting the treatment and the clinician administering it do not know if they received the antibodies or a harmless placebo.

“To demonstrate the safety and effectiveness of  AZD7442,  over the course of the next year we track who gets sick and who does not from COVID, and at the end of the study we open up the blinding information to see who got the antibody or the placebo,” Gasser says.

To explore participation in the clinical trials, please contact L. Allen Kindman, MD, at allen.kindman@iqvia.com.