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Alinia (nitazoxanide) / Lupin, Romark LabA Randomized, Double-Blind, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF) (clinicaltrials.gov) - Apr 13, 2020 - P3; N=300; Not yet recruiting; Sponsor: Romark Laboratories L.C.Virazole (ribavirin for inhalation solution) / Bausch HealthBausch Health initiates Virazole (ribavirin for inhalation solution, USP) clinical study in patients with Covid-19 (PRNewswire) - Apr 13, 2020 - "Bausch Health Companies Inc....today announced it has initiated a clinical trial program in Canada evaluating an investigational use of VIRAZOLE®....The initial clinical study has been approved by Health Canada and is expected to begin within the next few weeks. The Company is also in discussions with the U.S. Food and Drug Administration and health authorities in multiple countries regarding additional studies to evaluate VIRAZOLE as a treatment for COVID-19 infection. The Bausch Foundation is also continuing to work directly with health authorities in Italy to make VIRAZOLE for inhalation available free of charge in compassionate use in Italian hospitals."ifenprodil (NP-120) / Algernon PharmaAlgernon Receives Positive Feedback from U.S. FDA for Ifenprodil COVID-19 Human Trial; Appoints U.S. Ambassador (Rtd) Howard Gutman to Advisory Board (GlobeNewswire, Algernon Pharmaceuticals) - Apr 13, 2020 - "Algernon Pharmaceuticals Inc...is pleased to announce that it has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding the Company’s plans to conduct a phase 2 COVID-19 clinical trial using its repurposed drug NP-120 (Ifenprodil). Based on the feedback, the Company plans to submit, as soon as possible, an Investigational New Drug (IND) application to the FDA, to conduct a Phase 2 clinical trial with Ifenprodil, as a therapy for patients who experience respiratory complications as a result of contracting COVID-19."HB-adMSC / Hope BiosciencesHope Biosciences receives second FDA clearance for a phase II clinical trial for protection against Covid-19 (Businesswire) - Apr 13, 2020 - "Hope Biosciences…today announced that FDA has approved a Phase II clinical trial evaluating the safety and efficacy of Hope Biosciences’ allogeneic, adipose-derived mesenchymal stem cells (HB-adMSCs)….This Phase II study is a randomized, placebo-controlled, double-blind, single center study that is expected to enroll 100 frontline healthcare workers and first responders….This is the second of three New Drug Applications (INDs), related to COVID-19, that Hope Biosciences has filed with FDA. ‘It is our intention for both our first trial (an oen-label, autologous study) and this newly approved trial, to run in parallel’.” "mosedipimod (EC-18) / Enzychem LifesciencesEnzychem Lifesciences announces filing of US provisional patent for EC-18 to treat Covid-19 (Pharmaceutical Business Review (PBR)) - Apr 13, 2020 - "Enzychem Lifesciences announced that it has filed a provisional patent application with the United States Patent and Trademark Office (USPTO) covering treating COVID-19 infections and symptoms using EC-18, the Company's lead compound....Enzychem is currently seeking appropriate partners to develop and commercialize EC-18 worldwide as a potential treatment for COVID-19."nCoV-2019 vaccine / GSK, CEPI, University of QueenslandSanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19 (GlobeNewswire, Sanofi) - Apr 14, 2020 - "Sanofi and GSK today announce that they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19....Sanofi will contribute its S-protein COVID-19 antigen....GSK will contribute its proven pandemic adjuvant technology....The combination of a protein-based antigen together with an adjuvant is well-established and used in a number of vaccines available today....The companies plan to initiate phase I clinical trials in the second half of 2020 and, if successful, subject to regulatory considerations, aim to complete the development required for availability by the second half of 2021."U.S. FDA grants CytoSorb emergency use authorization for use in patients with Covid-19 infection (PRNewswire) - Apr 13, 2020 - "CytoSorbents Corporation...announced the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of CytoSorb® for use in patients with COVID-19 infection."lenzilumab (KB003) / HumanigenFDA approves initiation of Humanigen’s phase III study of lenzilumab in Covid-19 patients (Issuer Direct) - Apr 15, 2020 - "Humanigen, Inc....announced that FDA has given permission to commence a Phase III study of lenzilumab in patients with COVID-19....Humanigen plans to enroll patients in a multicenter, randomized, placebo-controlled, double-blinded clinical trial with lenzilumab for the prevention of respiratory failure and/or death in hospitalized patients with pneumonia associated with SARS-CoV-2 infection in COVID-19 patients."Ortho's total antibody test for Covid-19 receives emergency use authorization from FDA (PRNewswire) - Apr 14, 2020 - "The U.S. Food and Drug Administration (FDA) today announced it granted Emergency Use Authorization to Ortho Clinical Diagnostics' total antibody assay for COVID-19—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators. This test is one of the first high-throughput, automated* COVID-19 antibody tests to be granted Emergency Use Authorization....The test can also help screen plasma donations for convalescent plasma therapy..."hydroxychloroquine / Generic mfg.; chloroquine phosphate / Generic mfg.No evidence hydroxychloroquine works against COVID-19: WHO’s Ryan - Apr 13, 2020 - "'The potential of chloroquine and hydroxychloroquine are being taken seriously by the medical and research community,'...Michael Ryan said on Monday, adding that 'there is no empirical evidence from randomized control trials that hydroxychloroquine works against COVID-19'....Meanwhile, WHO chief Tedros Adhanom Ghebreyesus emphasized the importance of precautions against the novel coronavirus, which has brought the entire world to a standstill."
