In ACTIV-3, however, those who get the antibody treatment receive a dose of 7,000 milligrams.
Meanwhile, medical experts said that putting a pause on COVID-19 vaccine trials is not an uncommon practice.
It was halted at the request of an independent oversight panel, called a Data Safety and Monitoring Board (DSMB). The DSMB will review data again at a preplanned meeting on October 26.
Participants in the multicenter, adaptive, randomized, blinded, controlled trial were being randomized to treatment with LY-CoV555 plus current standard of care (SOC), remdesivir plus current SOC, or placebo plus current SOC. Researchers will continue to collect data from the 326 individuals already enrolled in the study while awaiting a recommendation from an independent data and safety monitoring board on the trial's future. Vaccine trials conducted by Johnson & Johnson and Astrazeneca have also been paused due to safety concerns after patients from both trials developed unrelated illnesses, according to the IndyStar. "Good to be cautious", Topol added.
Lilly has been studying its antibody treatment as a potential treatment for patients hospitalised with COVID-19, as well as in a number of additional patient populations.
Johnson & Johnson indicated that such a temporary suspension is normal in the case of major trials, which could include tens of thousands of people, stressing that the "suspension of the study" in terms of administering the expected vaccine doses differs from the "regulatory stoppage" that you require.
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ACTIV-3 uses an adaptive two-stage protocol design meant to allow for modification to test additional experimental therapeutics, as well as flexibly allow novel therapeutics to enter at either stage 1 or stage 2.
The treatments use antibodies demonstrated to home in on the coronavirus and neutralise it the most effectively. If an investigational therapeutic is unsafe or not likely to be effective, it will be dropped. But during this time, questions are also being raised about the vaccine and medicine of COVID-19. These patients have therefore been infected with the coronavirus longer and could have more severe symptoms than patients in other trials.
The decision by Eli Lilly comes after Johnson & Johnson announced that it learned of an "unexplained illness" in one of the volunteers that caused it to pause its Phase 3 coronavirus vaccine trial on Sunday.
Lilly said earlier this month it was applying for emergency use authorization for the antibody drug LY-CoV555 for patients with mild to moderate COVID-19.
All of these patients are given remdesivir, with either the Lilly antibody or placebo. Although clinical studies have resumed in many countries, the USA study is under clinical hold.
Lilly began its ACTIV-3 trial in August and is aiming to recruit 10,000 patients, primarily in the United States.