Independent observers have paused 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 drugmaker Eli Lilly, which is similar to the treatment. that US President Donald Trump recently received.
Lilly confirmed Tuesday that the study had been paused as a “precautionary measure” and said safety is the top priority. The company did not provide further details on what prompted this action to be taken.
The US National Institute of Allergic and Infectious Diseases, which is sponsoring the study, has not yet commented on the matter.
Antibodies are proteins that the body makes when an infection occurs; they stick to the virus and help it to be eliminated. The experimental drugs mentioned here are concentrated versions of one or two specific antibodies, which were the ones that worked best against the coronavirus in laboratory tests and in animals.
The study tested a single antibody that Lilly is developing together with the Canadian company AbCellera. Trump received an experimental two-antibody drug combination produced by Regeneron Pharmaceuticals Inc.
Lilly and Regeneron have asked the U.S. Food and Drug Administration to grant an emergency authorization to use their drugs to treat Covid-19 while advanced-phase studies continue.
The slow study, called ACTIV-3, began in August and aims to enroll 10,000 hospitalized patients with Covid-19 in the United States, Denmark and Singapore. They are all given remdesivir, which has been licensed in the United States as an emergency treatment against coronavirus, in addition to Lilly’s antibody or a placebo.
The main goals are to reduce the need for additional oxygen and reduce recovery time. Deaths, symptom relief, and other data are also being tracked. All medications are administered intravenously.
Those kinds of pauses are not unusual in long clinical studies. Unlike a study suspension imposed by government regulators, a pause is initiated by the drug’s trial sponsor and can often be resolved quickly.
The pause in Lilly’s study came one day after a temporary suspension to enrollment in a study of a coronavirus vaccine. Johnson & Johnson executives said Tuesday it will take a few days for them to learn more about an unexplained illness in a participant that caused the late-stage clinical trials of the vaccine to halt. The drugmaker did not disclose the nature of the disease.