Health Care

Covid-19 coronavirus: Possible safety issue spurs pause of antibody study

The Eli Lilly trial was created to test the benefits of the therapy on hundreds of people hospitalized with COVID-19, compared with a placebo.

Lilly said earlier this month it was applying for emergency use authorization (EUA) for the antibody drug, LY-CoV555, for patients with mild to moderate Covid-19 based on data from another clinical trial.

The problem has not been identified, but the company says safety is its top priority.

Neither Eli Lilly nor the NIAID, which is sponsoring the trial, have described the safety issue that prompted the decision to pause the study.

Two late-stage COVID-19 medical trials have been paused in the space of 24 hours over potential safety concerns, the latest setbacks to scientists in the long fight against the pandemic.

The pause in the Lilly study comes a day after a temporary halt to enrollment in a coronavirus vaccine study.

During the call, the company said it did not know whether the participant had received the vaccine or a placebo, according to press reports.

Such pauses for large clinical trials can occur and don't necessarily mean anything is wrong with the treatment.

More news: Judge Amy Coney Barrett's U.S. Supreme Court Confirmation Hearings

Enrollment for the Eli Lilly trial, which was sponsored by several branches of the National Institutes of Health and the Department of Veterans Affairs, among others, had been ongoing.

An independent data safety monitoring board recommended pausing enrollment in the USA government-sponsored trial, a company spokeswoman said in a statement. "Lilly is supportive of the decision by the independent (Data Safety Monitoring Board) to cautiously ensure the safety of the patients participating in this study". It's also testing an antibody cocktail.

The US Food and Drug Administration and the National Institutes of Health did not immediately reply to requests for comment.

The treatment is being developed with Canadian biotech AbCellera.Lilly shares closed almost 3%.

The study began in August across more than 50 sites in the United States, Denmark and Singapore with the aim of recruiting 10,000 people. The 300-participant trial known as ACTIV-3 will also treat patients in both the placebo arm and antibody arm with Gilead Sciences Inc.'s antiviral remdesivir, which is considered to be a standard of care.

The ACTIV-3 trial is created to test a monoclonal antibody developed by Eli Lilly in combination with remdesivir, an antiviral medication with emergency use authorization for the virus, the report said.

Lilly sought the EUA from USA regulators after publishing data in September showing LY-CoV555 helped cut hospitalisation and emergency room visits for COVID-19 patients.



Like this

loading...
loading...

Latest


14 October 2020
BTS leader irks China, worrying big brands
As of press time, the band's management company, Big Hit Entertainment , did not immediately respond. The report also talked about the commercial implications of the backlash.

14 October 2020
Jets Release Le'Veon Bell
Last season, Bell recorded career-lows in rushing yards (789), yards per carry (3.2), and rushing touchdowns (three). He missed the next three games before returning for Sunday's loss to the Cardinals as the Jets fell to 0-5.

14 October 2020
Google Fi begins selling "5G phones" from Samsung
Compared to the overall variant which has a better Snapdragon 865 processor , the Indian variant gets the Exynos 990 chipset. The handset has 48 megapixel primary, 8 megapixel ultra-wide lens, 5 megapixel depth sensor and 5 megapixel macro lens.

14 October 2020
Xbox Series X backwards compatibility explained: 'Significantly higher performance' promised
If you've already installed your games to an external drive, you can bring that with you to the Xbox Series X and Xbox Series S. Back to the frame rate doubling, and it's great to see how this can improve the experience for Fallout 4 and Xbox Series S.

14 October 2020
Texas Woman Waives Extradition In Pregnant Woman's Slaying
On being questioned, she said that she "had just given birth and her newborn baby, which was in the auto , was not breathing". She added that she is touched by the way everyone has "come together to love, pray for, and support" the family.

14 October 2020
YOUR MONEY: Here’s what you should know ahead of Amazon Prime Day
Disclosure: Many products on this website use affiliate links also we might make commission for any order made via the hyperlinks. Prime Day, typically held in July to boost summer sales, is now a kickoff to what will be an earlier holiday shopping season.

14 October 2020
Google Play No Longer Sells Music
The new playback interface includes information like the song and artist name, and a progress bar as the music plays. Secondly, if you don't want to transition to YouTube Music, you can keep your purchased music via Google Takeout .

14 October 2020
Alonso senses Renault "potential" after Barcelona test
Alonso will be able to complete 100km in the 2020-spec Renault auto in what is officially classed as a filming or promotional day. Alonso's most recent F1 experience came when he drove a Renault-powered McLaren in Bahrain for two days in April 2019.

14 October 2020
Razer's first gaming chair improves your posture
You can find all of the newly-released products available on Razer's official site , with several available right now to lock in. The chair, called the Razer Iskur , focuses on making sure gamers have proper posture and sit at an ideal position for gaming.

14 October 2020
Selena Gomez Reveals She 'Went Into A Bit Of Depression' During Lockdown
In her acceptance speech, the "Spring Breakers" star said she hopes to inspire others to pursue their dreams. Every day I would wake up and think why am I doing this? "They add nothing to my life".