NIH to Launch Massive ACTIV-6 Phase 3 Clinical Study
ーInvestigating Repurposed Drugs & Ivermectin May be on the Listー
TrialSite is pleased to report that
Francis S. Collins, MD, PhD,
the team at the National Institutes of Health (NIH)
will fund a large, randomized, placebo‑controlled Phase 3 clinical trial to test several existing prescription and over-the-counter medications for people to self-administer to treat symptoms of COVID-19.
ACCELERATING COVID-19 THERAPEUTIC INTERVENTIONS AND VACCINES (ACTIV)
On April 17, 2020
the National Institutes of Health (NIH)
announced the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership
to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines.
Coordinated by the Foundation for the National Institutes of Health (FNIH),
ACTIV
brings NIH together with its sibling agencies in the Department of Health and Human Services,
including the Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA);
other government agencies
including the Department of Defense (DOD) and Department of Veterans Affairs (VA); The Operation (formerly known as Operation Warp Speed);
streamline processes
to make the best use of biomedical research resources and testing of preclinical compounds.
the European Medicines Agency (EMA); and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies.
The research community is sifting through more than 100 potential preventives and treatments.
However, because so many studies are recruiting patients,
many of those studies
could fail to enroll enough participants to answer their research questions.
In addition, lack of coordination
could make interpretation and comparison of the results difficult.
Meanwhile, healthcare providers on the front lines are taking care of critically ill patients every day.
They need solid information grounded in research.
Opportunity
Through the ACTIV initiative,
NIH is pursuing four fast-track focus areas most ripe for opportunity,
each of which is led by a working group of senior scientists representing government, industry, non-profit, philanthropic, and academic organizations.
Fast Track Area #1
Develop a collaborative, streamlined forum to identify preclinical treatments.
Fast Track Area #2
Accelerate clinical testing of the most promising vaccines and treatments.
Fast Track Area #3
Improve clinical trial capacity and effectiveness.
Fast Track Area #4
Accelerate the evaluation of vaccine candidates to enable rapid authorization or approval.
Industry
AbbVie Amgen AstraZeneca Bristol Myers Squibb Dewpoint Therapeutics Eisai Eli Lilly and Company Gilead GlaxoSmithKline Johnson & Johnson Merck & Co., Inc. Moderna Novartis Novavax Pfizer Rhythm Therapeutics Roche-Genentech Sanofi Takeda Vir Biotechnology
ACTIV | National Institutes of Health (NIH)
https://www.nih.gov/research-training/medical-research-initiatives/activ