Use of Human Antibodies to Treat COVID-19: Q&A with Michael Dougan, MD, PhD

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On June 1, 2020, Eli Lilly announced the launch of its first antibody clinical trial to treat COVID-19. The placebo-controlled phase I trial will assess the safety and dosage of LY-CoV555, a neutralizing IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2. The LY-CoV555 antibody was identified from one of the first recovered COVID-19 patients and then rapidly developed to block viral attachment and entry into human cells, therefore neutralizing the virus.

Massachusetts General Hospital is one of the trial sites, which is being led by Michael Dougan, MD, PhD, physician in the Division of Gastroenterology at Mass General and director of the GI Center for Cancer Complications at Mass General Cancer Center. In this Q&A, Dr. Dougan explains what is currently known about this therapy and its potential to treat COVID-19 patients.

Q: What do we know about using human antibody therapeutic products today?

Dougan: Currently, there are antibody trials for HIV that use fully human antibodies derived from infected people who established strong immune responses. Fully human antibodies are very safe and appear to have less of a risk of an infusion reaction because all the components of the antibody came directly from a person. We believe that this treatment is less likely to have unexpected side effects from off target binding because we know that they can form naturally inside a person.

Q: What do we know about its potential to treat patients with coronavirus today?

Dougan: Although we have no clinic efficacy data yet, we do have reason to believe that this antibody will have some beneficial effects. First, the antibody was identified from a person who recovered from a SARS-CoV-2 infection, which means that its development correlated with disease control. Second, we have high quality in vitro testing that shows that the antibody binds to the spike protein of SARS-CoV-2 and prevents the virus from entering cells in culture. Combining these two pieces of information, we believe that this antibody has a high likelihood of being a neutralizing antibody that could improve recovery from SARS-CoV-2 infection.

Q: Why was this therapy prioritized at Mass General?

Dougan: Really for the reasons outlined above—this is an antibody derived from a patient who recovered from SARS-CoV-2 infection, so in that sense it is similar to convalescent plasma, but is a highly purified version of the active component of convalescent plasma that can be given to patients at a very high dose.

Q: What are the potential drawbacks or reservations associated with use of this drug?

Dougan: It is possible that using only one purified type of antibody is not as effective as having the broad spectrum of antibodies to the virus that would develop during a natural infection. It is also possible that if this antibody is highly effective, it might clear the virus before full natural immunity can develop.

Finally, there are some data from other viruses that certain types of antibodies can increase the efficiency of viral spread, but I believe that risk is lower if the antibody selected came from a patient who recovered from infection than it would be if the antibody were develop purely in a lab.

Q: What is Mass General's role in clinical trials with this drug?

Dougan: We are one of a few sites around the country that will be enrolling patients in both the phase 1 (inpatient) and phase 2 (outpatient) testing of this antibody. Both the inpatient and outpatient trials are now open at Massachusetts General Hospital and are recruiting.

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