View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
August 5, 2020updated 12 Jul 2022 11:40am

NIH starts trial of antibody treatments for Covid-19 patients

The US National Institutes of Health (NIH) has initiated a Phase III clinical trial, named ACTIV-3, to evaluate various types of monoclonal antibodies as potential treatments for hospitalised Covid-19 patients.

The US National Institutes of Health (NIH) has initiated a Phase III clinical trial, named ACTIV-3, to evaluate various types of monoclonal antibodies as potential treatments for hospitalised Covid-19 patients.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

The randomised, controlled trial has an adaptive design and a master protocol, allowing modification to include additional investigational therapies. It can also recruit additional participants in the middle of the study.

NIH said that the trial will be conducted at select hospitals globally that are covered under the existing clinical trial networks.

NIH director Dr Francis Collins said: “Under Operation Warp Speed, the US Government has brought together multiple agencies to accelerate the development, manufacture, and distribution of medical countermeasures for Covid-19.

“The ACTIV studies are just a few examples of this critical activity, which emphasises flexibility and minimises delays to generate scientifically sound results.”

ACTIV-3 uses a two-stage design. If an independent data and safety monitoring board (DSMB) review finds a treatment to be safe and effective in stage one, the therapeutic will be advanced to to stage two, which will enrol more subjects.

If a therapeutic is found to be unsafe or unlikely to be effective, it will be dropped.

Initially, the trial will assess Eli Lilly’s experimental monoclonal antibody LY-CoV555, which is being studied in alliance with Abcellera Biologics. LY-CoV555 is also being studied in NIH’s ACTIV-2 study in mild to moderate Covid-19 patients.

Lilly recently launched the Phase III BLAZE-2 trial of LY-CoV555 to prevent Covid-19 in residents and staff at long-term care facilities in the US.

The ACTIV-3 trial’s initial stage is set to enrol around 300 participants hospitalised with mild to moderate Covid-19 with fewer than 13 days of symptoms. Subjects will receive LY-CoV555 and standard of care, including the antiviral remdesivir.

Participants will be followed for 90 days after enrolment and will undergo regular examinations.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena