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Press release
Monday, February 8, 2021
The NIH trial has started recruiting participants.
An international randomized, controlled phase 3 clinical trial has begun to evaluate the safety and efficacy of an experimental combination of long-acting antibodies for the treatment of people hospitalized with COVID-19. The trial, which is part of a main protocol known as ACTIV-3, has an adaptive design allowing researchers to add new sub-studies of additional experimental agents. ACTIV-3 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health.
The new substudy evaluates AZD7442, an experimental long-acting antibody combination developed by the biopharmaceutical company AstraZeneca (Cambridge, UK). Antibodies are anti-infective proteins naturally made by the immune system. Antibodies can prevent viruses from infecting cells, usually by binding to the surface of the virus. In 2020, researchers at Vanderbilt University Medical Center, Nashville, Tennessee, isolated antibodies from two patients who had recovered from COVID-19. These antibodies, which were licensed to AstraZeneca, formed the basis of the synthetic antibodies included in AZD7442. AZD7442 is designed with AstraZeneca’s proprietary half-life extension technology which helps therapeutic work for a longer period of time. This experimental combination of long-acting antibodies could work both as a treatment and as a means of preventing infection with SARS-CoV-2, the virus that causes COVID-19. However, the ACTIV-3 trial will only test its efficacy as a therapy.
ACTIV-3 is part of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinated research strategy to prioritize and accelerate the development of the most promising treatments and vaccines. The main ACTIV-3 trial is designed to simultaneously conduct several different experimental therapy trials. The placebo group serves as a shared comparison group for two or more experimental therapies, increasing the chances that participants will receive treatment in this randomized trial. The new AZD7442 sub-study will run concurrently with two other sub-studies. A substudy evaluates VIR-7831, an experimental monoclonal antibody against SARS-CoV-2 developed through a partnership between GlaxoSmithKline (Brentford, UK) and Vir Biotechnology, Inc. (San Francisco). The other ongoing sub-study is evaluating the combination of BRII-196 and BRII-198, two research SARS-CoV-2 neutralizing monoclonal antibodies manufactured by Brii Biosciences (Durham, North Carolina and Beijing).
Initial participants in the new ACTIV-3 substudy will be hospitalized patients with mild to moderate COVID-19 with less than 13 days of symptoms. They will be randomized to receive either a placebo saline control or one of the three experimental therapies. After five days, participants will be rated on two seven-point ordinal scales, each ranging from ability to undertake usual activities with little or no symptoms to death.
If the ordinal results evaluated at five days, after approximately 150 volunteers have received AZD7442, indicate that AZD7442 is likely to be both safe and effective, enrollment in the trial will be expanded. At that time, an additional 700 participants, some of whom may have more severe cases of COVID-19, will be recruited and randomized into the trial. This larger pool of participants will allow researchers to better assess whether the treatment meets the trial’s primary endpoint of sustainable recovery. Participants will have met this criterion when they are released from the hospital and have lived at home for 14 consecutive days.
The principal investigator of ACTIV-3 is Jens Lundgren, MD, of the University of Copenhagen and Rigshospitalet. Leaders of participating networks include James Neaton, Ph.D., of the NIAID-sponsored INSIGHT Network; Taylor Thompson, MD, of the PETAL network, Annetine Gelijns, Ph.D., and Alan Moskowitz, MD, of CTSN, two networks sponsored by NHLBI; and Victoria Davey, Ph.D., MPH, of the US Department of Veterans Affairs.
Those interested in learning more about the trial can visit ClinicalTrials.gov and search for ID NCT04501978.
NIAID conducts and supports research – at the NIH, in the United States, and around the world – to study the causes of infectious and immune-mediated diseases and to develop better ways to prevent, diagnose, and treat these diseases. Press releases, fact sheets and other materials related to NIAID are available on the NIAID website.
About the National Institutes of Health (NIH):NIH, the country’s medical research agency, comprises 27 institutes and centers and is part of the US Department of Health and Human Services. The NIH is the premier federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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