NIAID set to conduct large monoclonal SARS-CoV-2 antibody clinical trial

By Angela Betsaida B. Laguipo, BSNJan 6 2021

The coronavirus disease 2019 (COVID-19) pandemic continues to spread worldwide, with a new highly infectious strain identified in the UK, causing surges of new cases. Caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 can cause mild to severe illness, while some do not experience any symptoms at all.

A large clinical trial, known as the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-2), is set to take place, which aims to test monoclonal antibody efficacy and safety in people who have mild or moderate COVID-19.

Large Clinical Trial Will Test Combination Monoclonal Antibody Therapy for Mild/Moderate COVID-19. Image Credit: ktsdesign / Shutterstock

Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in Maryland, USA, the trial uses two experimental antibodies, BRII-196 and BRII-198, which target SARS-CoV-2.

The ACTIV-2 trial

The ACTIV program is a public-private partnership that helps develop a coordinated research strategy to speed up the development of effective and promising treatments as well as vaccine candidates. The ACTIV-2 clinical trial aims to evaluate several investigational agents compared to placebo in adults with mild to moderate COVID-19.

In the trial, the investigators will enroll participants from many sites across the globe. It started on August 4, 2020, evaluating the LY-CoV555 or bamlanivimab, an investigational monoclonal antibody, which was discovered by AbCellera Biologics in Canada. The antibody was further developed and manufactured by Eli Lilly and Company in Indiana, United States, in collaboration with AbCellera.

By November 2020, the US Food and Drug Administration (FDA) granted bamlanivimab an Emergency Use Authorization (EUA) to treat patients with mild to moderate COVID-19. The drug is intended for use in adults and children over 12 years old, who are at high risk for progressing to severe COVID-19 or hospitalization.

The BRII-196 and BRII-198 monoclonal antibodies

Antibodies are specialized, Y-shaped proteins produced by the immune system in response to the presence of a foreign substance, called an antigen. These antibodies recognize and latch onto antigens to remove them from the body. Antigens come in many forms, including pathogens like bacteria and viruses.

The BRII-196 and BRII-198 are investigational neutralizing monoclonal antibodies that aim to fight off SARS-CoV-2 to prevent the illness from progressing. Developed by Brii Biosciences, these are synthetic versions of the antibodies that can fight off the SARS-CoV-2 infection.

The trial design aims to enroll 220 participants. These antibodies will be administered to half of the participants via intravenous infusions. The other half will receive a placebo and both groups will attend clinic or at-home visits by healthcare providers to monitor their condition for 72 weeks.

The trial is designed to study the therapies’ efficacy in a small group of volunteers. After, these will be administered to a larger group if the antibodies appear to be safe and effective in preventing disease progression in COVID-19 patients.

If there are no serious safety issues in the Phase 2 trial, the next step is the Phase 3 trial, wherein the investigators aim to enroll 622 additional volunteers. In total, the ACTIVE-2 trial will have 842 participants.

The main objective of the Phase 3 trial is to determine if the therapy can prevent hospitalization, disease progression, or death by 28 days after entering the study.

COVID-19 by the numbers

The world is in dire need of an effective treatment for COVID-19. As the pandemic evolves, more cases are being reported in many countries that are experiencing successive waves of infections.

To date, there are more than 86.47 million cases across the globe. Of these, 1.86 million people died.

The USA reports the highest number of cases, reaching 21 million, with more than 357,000 deaths. India, Brazil, and Russia follow, with more than 10.37 million, 7.81 million, and 3.27 million cases, respectively. The UK reports surging COVID-19 cases during its second wave since October, with the number of cases topping 2.78 million.