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Clinical trial of therapeutics for severely ill hospitalized COVID-19 patients begins


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. ....

United States , Salt Lake City , University Of Utah , Foster City , Samuel Brown , James Neaton , Alan Moskowitz , Taylor Thompson , Annetine Gelijns , Anthonys Fauci , Garyh Gibbons , Us Department Of Health , Human Services , National Institute Of Allergy , National Institutes Of Health , International Network For Strategic Initiatives In Global , Research Facility , Cardiothoracic Trials Surgical Network , Us Department Of Veterans Affairs , Blood Institute , National Heart , Fort Detrick , National Institutes , National Institute , Infectious Diseases , Vasoactive Intestinal Peptide ,

New Phase 3 trial of therapeutics begins enrolling severely ill hospitalized COVID-19 patients


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 ....

United States , Salt Lake City , University Of Utah , Foster City , James Neaton , Alan Moskowitz , Taylor Thompson , Annetine Gelijns , Anthonys Fauci , Emily Henderson , Samuel Brown , Garyh Gibbons , National Institute Of Allergy , National Institutes Of Health , International Network For Strategic Initiatives In Global , Cardiothoracic Trials Surgical Network , Us Department Of Veterans Affairs , Blood Institute , National Heart , National Institutes , National Institute , Infectious Diseases , Vasoactive Intestinal Peptide , Acute Respiratory Distress Syndrome , Safety Monitoring Board , Intermountain Healthcare ,

Altasciences Conducts Phase I Study in Healthy Normal Subjects for RLS-0071 for Treatment of Acute Lung Injury Due to COVID-19 Pneumonia


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Altasciences is pleased to support ReAlta Life Sciences by conducting a Phase I trial to evaluate RLS-0071 for treatment of Acute Lung Injury (ALI) as a result of viral infections, such as COVID-19, respiratory syncytial virus (RSV), and influenza. As part of the ReAlta ALI program underway, the Phase I trial is a single-ascending dose, randomized, double-blind, placebo-controlled, adaptive-design study to evaluate the safety, tolerability, PK, and PD of RLS-0071 in healthy subjects, performed at the Altasciences clinical pharmacology unit in Montreal, Canada.
Ingrid Holmes, Vice President, Global Clinical Operations at Altasciences, says,
Our teams are proud to have the opportunity to be involved in the clinical conduct and bioanalytical analysis for this important first-in-human trial. Being able to prioritize COVID-19 therapies by contributing critical data to the development of potentially life-altering medications, such as RLS-0071, is tremendously rewa ....

Julie Ann Cabana , Ulrich Thienel , Ingrid Holmes , Realta Life Sciences , Acute Lung Injury , Vice President , Global Clinical Operations , Realta Life , Chief Executive , Co Vid , ஜூலி ஆண்டு கான , இஂக்ரிட் ஹோம்ஸ் , எடுப்போசை நுரையீரல் காயம் , துணை ப்ரெஸிடெஂட் , உலகளாவிய மருத்துவ செயல்பாடுகள் , தலைமை நிர்வாகி , இணை வித் ,