New York- Independent observers have halted the enrollment process in a study testing a cocktail to treat Covid-19 that includes the antiviral drug remdesivir in addition to an experimental antibody therapy being developed by drug maker Eli Lilly, which is similar to the treatment. recently received by the President of the United States, Donald Trump.
Lilly confirmed today that the study has been suspended as a “precautionary measure” and said safety is the top priority. The company did not provide further details on why this action was taken.
The U.S. National Institute of Allergic and Infectious Diseases, which is sponsoring the study, has yet to comment on the matter.
Antibodies are proteins that the body makes when an infection occurs; they adhere to the virus and contribute to its elimination. The investigational drugs mentioned here are concentrated versions of one or two specific antibodies, which were the ones that worked best against coronavirus in laboratory and animal tests.
The study tested a single antibody that Lilly is developing in collaboration with the Canadian company AbCellera. Trump has received an experimental two-antibody drug combination produced by Regeneron Pharmaceuticals Inc.
Lilly and Regeneron have asked the U.S. Food and Drug Administration for an emergency authorization to use their drugs to treat COVID-19 while late-phase studies continue.
The hobby study, called ACTIV-3, began in August and aims to enroll 10,000 hospitalized COVID-19 patients in the United States, Denmark and Singapore. All are receiving remdesivir, which has been approved in the United States as an emergency treatment for the coronavirus, in addition to Lilly’s antibody or a placebo.
The main goals are to reduce the need for supplemental oxygen and to reduce recovery time. Deaths, relief of symptoms, and other data are also recorded. All medications are administered intravenously.
These types of interruptions are not unusual in long clinical studies. Unlike a study suspension imposed by government regulators, the drug’s trial sponsor initiates a hiatus and can often be resolved quickly.
The break in Lilly’s study came one day after a temporary suspension of recruitment for a coronavirus vaccine study. Johnson & Johnson executives said Tuesday it would take them a few days to learn more about an unexplained illness in one participant that led to late-stage clinical trials of the vaccine being halted. The drug maker did not disclose the nature of the disease.