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A Study of Markers of Cosmic Radiation Exposure and Effect Among Flight Crews
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Research Initiative
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CDC
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NCI
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National Cancer Institute (NCI) and Centers for Disease Control and Prevention (CDC) are collaborating on a cross-sectional study of 83 airline pilots and 50 university faculty to assess the relation of stable chromosome translocations with cosmic radiation exposure.
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A Study to Evaluate the Effects of fixed dose Flavonoid Isoquercetin on thrombo-inflammatory biomarkers in subjects with stable Sickle Cell Disease
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Research Initiative
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FDA
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NHLBI
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A Study to Evaluate the Effects of fixed dose Flavonoid Isoquercetin on thrombo-inflammatory biomarkers in subjects with stable Sickle Cell Disease
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A Working Group to Consider the Question of Federal Public Health and Medical Resource Allocation
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Committee, Work group, Advisory group, or Task Force
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OS
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CC
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The National Institutes of Health (NIH) Clinical Center is participating in a working group to consider the question of federal public health and medical resource allocation. The group developed a framework for allocation of federal resources during scarcity after engaging with stakeholders in ethics, disaster preparedness, and emergency management.
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A5349/TBTC S31 - Rifapentine - Containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-Label, Controlled Phase 3 Clinical Trial
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Research Initiative
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CDC
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NIAID
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The purpose of this research initiative is to provide scientific discovery to improve patient care and safety by reducing the duration of treatment for drug-susceptible pulmonary tuberculosis to 4 months by using new regimens, including high-dose rifapentine.
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A5418: Study of Tecovirimat For Human Monkeypox Virus (STOMP)
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Other
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CDC, FDA
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NIAID
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To see if tecovirimat is safe, and whether it helps treat monkeypox infection.
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Abuse Liability Evaluation for Research, Treatment, and Training (ALERTT)
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Research Initiative
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FDA
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NIDA
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Abuse Liability Evaluation for Research, Treatment, and Training (ALERTT) is part of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration (FDA). The mission of the (ACTTION) is to identify, prioritize, sponsor, coordinate, and promote innovative activities with a special interest in optimizing clinical trials that will expedite the discovery and development of improved analgesic, anesthetic, and addiction treatments for the benefit of public health.
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Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Therapeutics Working Group
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, ASPR
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NIAID
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Develop master protocols to support the ACTIV Research; Prioritize putative therapeutics candidates for entry into trials
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Accelerating COVID-19 Therapeutic Interventions and Vaccines-1: Immune Modulators (ACTIV-1)
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Research Initiative
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FDA, ASPR
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NCATS
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The ACTIV public-private partnership has evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized the most promising candidates, designed and harmonized adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates. The ACTIV-1 master protocol tested three promising immune modulator compounds, a class of drugs that help minimize the deleterious effects of an overactive immune response to SARS-CoV-2 infection. This Phase 3 trial enrolled hospitalized adults with moderate to severe COVID-19 disease. The goal of the trial was to evaluate the safety and efficacy of each immune modulator when given as an add-on therapy to standard of care (SOC) at local clinics, which may have included remdesivir (provided as part of the study to all participants), an antiviral approved for treatment of COVID-19. The different treatments were assessed with respect to illness severity, recovery speed, mortality, and hospital resource utilization. The trial is completed, and results on the two immune modulators that showed efficacy are available on medRxiv.
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Accelerating COVID-19 Therapeutic Interventions and Vaccines-6: Outpatient Repurposed Drugs (ACTIV-6)
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Research Initiative
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CDC, FDA, ASPR
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NCATS, NIAID, NHLBI
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The ACTIV public-private partnership has evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized the most promising candidates, designed and harmonized adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates. ACTIV-6 is designed to test the effectiveness of repurposed drugs (drugs that are FDA-approved for non-COVID-19 indications and have known safety profiles) in reducing the duration and severity of symptoms associated with mild-to-moderate COVID-19. The large, randomized, placebo-controlled Phase 3 trial is enrolling outpatient participants who are at least 30 years old, have tested positive for SARS-CoV-2 infection and show two or more mild-to-moderate symptoms of COVID-19 for no more than seven days. Results for ivermectin, fluvoxamine and fluticasone are available on medRxiv. Results for ivermectin and fluvoxamine have been published in JAMA. Testing of montelukast is ongoing.
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Accelerating Medicines Partnership (AMP)
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Other
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FDA
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OD/OSP, NIA, NIDDK, NIAMS, NINDS, NIMH
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Public-private partnership between the National Institutes of Health (NIH), the Food and Drug Administration (FDA), multiple biopharmaceutical companies and multiple non-profit organizations, and managed by the Foundation for NIH (FNIH), to transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets for therapeutics.
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