[ad_1]
SINGAPORE – The National Center for Infectious Diseases (NCID) temporarily stopped enrolling Covid-19 patients for a monoclonal antibody trial after the US pharmaceutical company that developed the drug had to stop the trial last week due to concerns from security.
Singapore is only the third country to participate in the trial after the United States and Denmark, and this is the country’s first phase 3 monoclonal antibody trial.
The NCID announced that it was ready to enroll its first patients in the trial starting October 6, and a week later, on October 13, the pharmaceutical 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 issue was or how many people were affected.
“Following the instructions of the Active-3 safety monitoring board, the NCID immediately paused the screening and enrollment of new Covid-19 patients for the trial,” the NCID told The Straits Times on Monday (October 19). ).
Suspension does not affect the treatment of patients who have already enrolled in the trial.
So far, a Singaporean patient has joined the study and is doing well, with no adverse effects related to the drugs involved in the study, the NCID said.
The center added that the safety monitoring board is reviewing the study data further and will advise in the coming weeks if it is safe to continue testing.
“Rigorous monitoring of patient safety is a critical component in the development of new treatments. It is not unusual for any clinical trial to be temporarily paused to review the data in more detail if potential concerns arise,” the center added.
The NCID previously said its goal is to enroll 100 local patients in the study.
Active-3 monoclonal antibody is a highly active, purified antibody that targets the coronavirus spike protein.
On October 8, the NCID said it will enroll Covid-19 patients with pneumonia or high-risk patients over the age of 45, with chronic health problems such as diabetes or high blood pressure.
Patients will receive the antibody or a placebo, and all will receive the antiviral drug remdesivir.
Patients can also be given the steroid dexamethasone, a drug that widely 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 that was suspended last week.
Johnson & Johnson had to stop advanced trials for a possible Covid-19 vaccine after a volunteer fell ill.
[ad_2]
