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Jakafi oral (ruxolitinib) / Novartis, IncytePhase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID) (clinicaltrials.gov) - Apr 24, 2020 - P3; N=402; Not yet recruiting; Sponsor: Novartis Pharmaceuticalsvafidemstat (ORY-2001) / OryzonOryzon to initiate ESCAPE: A phase II clinical trial to test efficacy of vafidemstat in severely ill Covid-19 patients (GlobeNewswire) - Apr 24, 2020 - "Oryzon Genomics, S.A....it has received approval from the Spanish Drug Agency (AEMPS) to conduct a Phase II clinical trial with vafidemstat in seriously ill COVID-19 patients. The study, named ESCAPE (Efficacy and Safety of a Combined treatment with vafidemstat to prevent ARDS in adult Patients with severE COVID-19)...is an open-label, randomized, double-arm Phase II trial to assess the efficacy and tolerability of vafidemstat….Initially, it is planned to include 20 patients in each arm of the trial. In principle, initially two hospitals will participate (H. Valle de Hebrón and H. del Mar, both in Barcelona, Spain), while more centers can be added if necessary."Vicromax (merimepodib) / BioSig TechBioSig subsidiary ViralClear submits Investigational New Drug application to the FDA for phase II clinical trials for merimepodib, an orally administered treatment for patients with Covid-19 (GlobeNewswire) - Apr 24, 2020 - "BioSig Technologies, Inc....today announced that its subsidiary ViralClear Pharmaceuticals, Inc. submitted an Investigational New Drug (IND) Application to the Food and Drug Administration (FDA) for its Phase II clinical trial with Merimepodib as a treatment for COVID-19. The study will be a randomized, placebo-controlled trial to evaluate the efficacy and safety of Merimepodib in patients with COVID-19. The placebo-controlled Phase II clinical trial calls for 20 planned patients from three Mayo Clinic sites....Data from the Phase II trial is expected within three months of the commencement of the trial."bucillamine / Revive TherapRevive Therapeutics announces U.S. FDA recommendation to proceed directly into a phase 3 confirmatory clinical trial (GlobeNewswire) - Apr 23, 2020 - "Revive Therapeutics Ltd....announced today that it has received positive feedback....The FDA recommended that the Company proceed directly into a Phase 3 confirmatory clinical trial ('Phase 3 study') to evaluate Bucillamine for the treatment of patients with mild-moderate COVID-19....FDA provided valuable guidance on study design and outcome measures for the Phase 3 study....The Company...actively incorporating the pre-IND meeting guidance and preparing the package for submission to the FDA. The Company expects to file the final IND within the next 60 days and will plan to initiate the Phase 3 study thereafter."Baxter obtains U.S. FDA emergency use authorization for Oxiris blood purification filter for Covid-19 treatment (Baxter Press Release) - Apr 24, 2020 - "Baxter International Inc....announced it has received emergency use authorization (EUA) from the U.S. FDA for the company’s Oxiris filter set to treat patients who have confirmed COVID-19 and have been admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure in need of blood purification therapy to reduce pro-inflammatory cytokine levels, including use in continuous renal replacement therapy (CRRT)."DiaSorin obtains FDA emergency use authorization and BARDA funding for SARS-CoV-2 IgG serology kit for Covid-19 testing in the U.S. (PRNewswire) - Apr 25, 2020 - "DiaSorin...announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for the LIAISON® SARS-CoV-2 S1/S2 IgG test....DiaSorin recently signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services to obtain funding aimed at making the test available in the U.S."MetaBlok (lsalt peptide) / Arch BiopartnersArch Biopartners Submits Application to Health Canada to Conduct COVID19 Phase II Human Trial for Metablok to Prevent Lung and Kidney Inflammation (GlobeNewswire, Arch Biopartners) - Apr 23, 2020 - "Arch Biopartners Inc....today announced it has submitted a Clinical Trial Application to Health Canada for a Phase II human trial for its lead drug Metablok (LSALT peptide) to prevent lung and kidney inflammation in patients with COVID19. The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide....As a result of clinical interest to support the Phase II trial in the United States, Arch will be preparing an application to the U.S. Food and Drug Administration as well as other authorities within the American hospital system."Ortho launches second Covid-19 antibody test with 100% specificity (PRNewswire) - Apr 25, 2020 - "Ortho Clinical Diagnostics...today introduced and announced the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization to its second COVID-19 antibody test—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test)....Ortho plans to manufacture several million COVID-19 IgG antibody tests each month."remdesivir (GS-5734) / GileadGilead Sciences statement on data from remdesivir study in patients with severe COVID-19 in China (Gilead Press Release) - Apr 23, 2020 - "'Today, information from the first clinical study evaluating the investigational antiviral remdesivir in patients with severe COVID-19 disease in China was prematurely posted on the World Health Organization website....We also anticipate data at the end of May from NIAID's double-blind, placebo-controlled study of remdesivir in patients across a range of disease severity."WHO warns against coronavirus “immunity passports” due to reinfection concerns (Vox) - Apr 25, 2020 - "Lipsitch says based on current evidence and what the scientific community knows about similar viruses, it's only possible to make 'an educated guess' as to immunity: 'After being infected with SARS-CoV-2, most individuals will have an immune response, some better than others. That response, it may be assumed, will offer some protection over the medium term - at least a year - and then its effectiveness might decline,' he wrote....And earlier in April, Anthony Fauci...said it's 'possible' that the US would consider such a policy in the future. 'I mean, it's one of those things that we talk about when we want to make sure that we know who the vulnerable people are and not,' he told CNN on April 10. 'This is something that's being discussed. I think it might actually have some merit, under certain circumstances.'"
