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hydroxychloroquine / Generic mfg.MHRA suspends recruitment to COVID-19 hydroxychloroquine trials (GOV.UK) - Jun 16, 2020 - "The Medicines and Healthcare products Regulatory Agency (MHRA) has instructed UK clinical trialists using hydroxychloroquine to treat or prevent coronavirus (COVID-19) to suspend recruitment of further participants....We followed the emerging concerns about use of hydroxychloroquine in COVID-19, and took into consideration the results from two different trials, including the UK’s RECOVERY trial which has provided convincing evidence of no meaningful mortality benefit in hospitalised patients with COVID-19."Actemra IV (tocilizumab) / Roche, JW PharmaRoche rheumatoid arthritis drug fails to help COVID-19 patients in Italian study (Reuters) - Jun 18, 2020 - P2, N=398; NCT04346355; "Roche’s rheumatoid arthritis drug Actemra failed to help patients with early-stage COVID-19 pneumonia in an Italian study....It is pressing ahead with testing Actemra in another trial against COVID-19....The trial, which enrolled 126 patients, about a third of the intended number, was stopped early after an interim analysis raised doubts about the anti-inflammatory medicine’s effectiveness....Meanwhile, Roche has completed enrolment of its own Actemra study in patients hospitalized with severe COVID-19 pneumonia. That 'will provide robust evidence about the benefit/ risk profile', a Roche spokesman said, with data expected in the next few months."remdesivir / Generic mfg.Favipiravir and Remdesivir get approval for treatment (The Economic Times) - Jun 20, 2020 - "In a seperate development, Maharashtra's health minister Rajesh Tope said that Cipla and Hetero have received emergency marketing approval for Remdesivir for the treatment of severe Covid-19 patients from the drug controller of India..."Aclaris Therapeutics Supports Investigator-Initiated Clinical Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19 (GlobeNewswire) - Jun 17, 2020 - "Aclaris Therapeutics, Inc....today announced that the FDA has allowed an investigational new drug application to evaluate ATI-450...in hospitalized patients with COVID-19. Aclaris is supporting an investigator-initiated trial of ATI-450 for cytokine release syndrome (CRS) in 36 hospitalized patients with COVID-19, and will provide funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial....The trial is a Phase 2a, randomized, double-blind, placebo-controlled trial..."mavrilimumab (KPL-301) / KiniksaKiniksa Announces Lancet Rheumatology Publication of Clinical Outcomes with Mavrilimumab in COVID-19 (GlobeNewswire) - Jun 17, 2020 - P=Obs, N=1000; COVID-BioB (NCT04318366); "Kiniksa Pharmaceuticals, Ltd....today announced that clinical outcomes data from the open-label treatment protocol with mavrilimumab, an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα)...The 28-day clinical outcomes data from the open-label treatment protocol with mavrilimumab are described..."MetaBlok (lsalt peptide) / Arch BiopartnersFDA Grants Arch Biopartners Permission to Proceed with Phase II trial to Evaluate Metablok (LSALT peptide) for the Treatment of COVID-19 patients (GlobeNewswire) - Jun 16, 2020 - "Arch Biopartners Inc....today announced that the U.S. Food and Drug Administration (FDA) has granted permission to the Company to proceed with a Phase II trial in the U.S. for its lead drug Metablok....The Company expects to begin the Phase II trial before the end of the summer, 2020."IFX-1 / Staidson Biopharma, InflaRxInflaRx Reports Encouraging Topline Results from the Exploratory Phase II Part of the Adaptive Randomized Phase II/III Trial of IFX-1 in COVID-19 (GlobeNewswire) - Jun 17, 2020 - P2/3, N=30; "InflaRx...announced today interim results from the first 30 patients treated in the adaptive randomized Phase II/III trial....Relative change in the oxygenation index at day 5 showed no differences between treatment groups. However, IFX-1 treatment was associated with a lower 28-day all-cause mortality when compared to the best supportive care group....InflaRx is now evaluating continuing the study in an adequately powered, placebo-controlled, double blinded, Phase III part..."Decadron (dexamethasone) / Merck (MSD)The world will soon get coronavirus vaccine, health expert Anthony Fauci hopeful (Livemint) - Jun 19, 2020 - "On the treatment front, Fauci said he was 'very impressed' with results from a British trial into the steroid dexamethasone, which was found to reduce deaths among COVID-19 patients on ventilators by a third. However, given it works by suppressing the abnormal immune response that damages the body's organs, rather than attacking the virus, Fauci cautioned it should not be prescribed too soon after a person was infected."dexamethasone / Generic mfg.WHO welcomes preliminary results about dexamethasone use in treating critically ill COVID-19 patients (World Health Organization) - Jun 16, 2020 - "'This is the first treatment to be shown to reduce mortality in patients with COVID-19 requiring oxygen or ventilator support,' said Dr Tedros Adhanom Ghebreyesus...'This is great news and I congratulate the Government of the UK, the University of Oxford, and the many hospitals and patients in the UK who have contributed to this lifesaving scientific breakthrough.'"remdesivir / Generic mfg.Gilead to assess remdesivir in paediatric Covid-19 patients (Clinical Trials Arena) - Jun 18, 2020 - "The trial is expected to be completed in December this year....Merdad Parsey said in a statement: 'From the onset of the pandemic, Gilead has advanced the development of our investigational antiviral remdesivir for the treatment of Covid-19, in parallel with emerging knowledge about the disease. 'While the novel coronavirus appears to disproportionally affect adults, especially the elderly and those with underlying health conditions, concerning reports have been documented of children and young adults being hospitalised with Covid-19 and related autoimmune symptoms.'"
