The halt does not affect the treatment of patients who have already been enrolled in the trial.PHOTO: ST FILE
SINGAPORE — The National Center for Infectious Diseases (NCID) has temporarily stopped enrolling Covid-19 patients for a monoclonal antibody trial after the American pharmaceutical company that developed the drug had to halt the trial due to safety concerns last week.
Singapore is only the third country to be involved in the trial after the United States and Denmark, and this is the nation’s first Phase 3 monoclonal antibody trial.
The NCID announced that it was ready to enrol its first patients in the trial as of Oct 6, and a week later on Oct 13, the pharma company, Eli Lilly, said it had to pause the late-stage trial, called Activ-3. The drugmaker did not disclose details about what the safety concern was or how many people were affected.
“Following instructions from the Active-3 safety monitoring board, the NCID immediately paused screening and enrolment of new Covid-19 patients for the trial,” the NCID told The Straits Times on Monday (Oct 19).
The halt does not affect the treatment of patients who have already been enrolled in the trial.
So far, one patient in Singapore has joined the study and is well, with no adverse effects related to the drugs involved in the study, said the NCID.
The centre added that the safety monitoring board is reviewing the study’s data further and will advise in the next few weeks whether it is safe to continue with the trial.
“Rigorous monitoring of patient safety is a critical component in the development of new treatments. It is not unusual that any clinical trial may be temporarily paused to review data in more detail if any possible concerns are raised,” the centre added.
The NCID previously said that it aims to enrol 100 local patients in the study.
Active-3’s monoclonal antibody is a purified, highly active antibody that targets the spike protein of the coronavirus.
On Oct 8, the NCID said it will enrol Covid-19 patients with pneumonia or high-risk patients older than 45, with chronic health problems such as diabetes or high blood pressure.
The patients will get either the antibody or a placebo, and all will be given the antiviral drug remdesivir.
Patients may also be given the steroid dexamethasone, a drug which broadly suppresses the body’s immune response and can be used to treat severe asthma and severe allergic reactions.
Active-3 is not the only Covid-19-related trial to be suspended last week.
Johnson & Johnson had to pause advanced trials for a potential Covid-19 vaccine after a volunteer fell ill.