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Patients with acute respiratory failure may now enroll in NIH-sponsored trial.
A CCL-81 cell (purple) infected with SARS-CoV-2 virus particles, which are the small spherical structures (teal). The string-like protrusions extending from the cell are cell projections or pseudopodium, whose primary purposes are cell mobility and ingestion of nutrients. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland.NIAID
A new Phase 3 trial to test the safety and efficacy of therapeutics for COVID-19 has begun enrolling patients hospitalized with life-threatening cases of COVID-19, including those with acute respiratory failure. The trial is supported by two components of the National Institutes of Health, the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung and Blood Institute (NHLBI), and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership.
New Phase 3 trial of therapeutics begins enrolling severely ill hospitalized COVID-19 patients
A new Phase 3 trial to test the safety and efficacy of therapeutics for COVID-19 has begun enrolling patients hospitalized with life-threatening cases of COVID-19, including those with acute respiratory failure. The trial is supported by two components of the National Institutes of Health, the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung and Blood Institute (NHLBI), and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership.
The randomized, blinded, placebo-controlled clinical trial is called ACTIV-3 Critical Care. It will begin by testing Zyesami, a formulation of aviptadil acetate, produced by NeuroRx, Wilmington, Delaware, and the antiviral remdesivir (Veklury), developed by Gilead, Foster City, California. Aviptadil is a synthetic version of Vasoactive Intestinal Peptide or VIP, whi
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An international randomized, controlled Phase 3 clinical trial has begun evaluating the safety and efficacy of an investigational long-acting antibody combination for treating people hospitalized with COVID-19. The trial, part of a master protocol known as ACTIV-3, has an adaptive design allowing investigators to add new sub-studies of additional investigational agents. ACTIV-3 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The new sub-study is evaluating AZD7442, an investigational long-acting antibody combination developed by biopharmaceutical company AstraZeneca (Cambridge, United Kingdom). Antibodies are infection-fighting 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 r
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IMAGE: Colorized scanning electron micrograph of an apoptotic cell (green) heavily infected with SARS-COV-2 virus particles (orange), isolated from a patient sample. Image captured at the NIAID Integrated Research Facility (IRF). view more
Credit: NIAID
Preliminary results of a phase 3, randomized, placebo-controlled clinical trial testing the investigative monoclonal antibody LY-CoV555 in hospitalized COVID-19 patients were published today in the
New England Journal of Medicine. The antibody did not provide clinical benefit compared to placebo. The trial, which had been halted to new enrollment in late October following a recommendation by the independent Data and Safety Monitoring Board (DSMB), is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.