Adv Ther
Chimerix, Inc, Durham, NC, USA.
Published: January 2021
Introduction: The COVID-19 global pandemic caused by the novel coronavirus, SARS-CoV-2, and the consequent morbidity and mortality attributable to progressive hypoxemia and subsequent respiratory failure threaten to overrun hospital critical care units globally. New agents that address the hyperinflammatory "cytokine storm" and hypercoagulable pathology seen in these patients may be a promising approach to treat patients, minimize hospital stays, and ensure hospital wards and critical care units are able to operate effectively. Dociparstat sodium (DSTAT) is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, with the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding compared to commercially available heparin.
Methods: This study is a randomized, double-blind, placebo-controlled, phase 2/3 trial to determine the safety and efficacy of DSTAT added to standard of care in hospitalized adults with COVID-19 who require supplemental oxygen. Phase 2 will enroll 12 participants in each of two dose-escalating cohorts to confirm the safety of DSTAT in this population. Following review of the data, an additional 50 participants will be enrolled. Contingent upon positive results, phase 3 will enroll approximately 450 participants randomized to DSTAT or placebo. The primary endpoint is the proportion of participants who survive and do not require mechanical ventilation through day 28.
Discussion: Advances in standard of care, recent emergency use authorizations, and positive data with dexamethasone have likely contributed to an increasing proportion of patients who are surviving without the need for mechanical ventilation. Therefore, examining the time to improvement in the NIAID score will be essential to provide a measure of drug effect on recovery. Analysis of additional endpoints, including supportive biomarkers (e.g., IL-6, HMGB1, soluble-RAGE, D-dimer), will be performed to further define the effect of DSTAT in patients with COVID-19 infection.
Trial Registration: ClinicalTrials.gov identifier; NCT04389840, Registered 13 May 2020.
Download full-text PDF |
Source |
---|---|
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7588947 | PMC |
http://dx.doi.org/10.1007/s12325-020-01539-z | DOI Listing |
Neurology
January 2025
APHP- Salpêtrière Hospital, DMU BioGem, CNRS, INSERM, Paris Brain Institute, Sorbonne University.
Background And Objectives: Brain energy deficiency occurs at the early stage of Huntington disease (HD). Triheptanoin, a drug that targets the Krebs cycle, can restore a normal brain energetic profile in patients with HD. In this study, we aimed at assessing its efficacy on clinical and neuroimaging structural measures in HD.
View Article and Find Full Text PDFJ Sports Med Phys Fitness
January 2025
Physical Medicine and Rehabilitation Unit, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy.
Introduction: Sports injuries involving bi-articular muscles like the hip flexors, hamstrings, quadriceps, and gastrocnemius significantly affect athletes' performance and quality of life. Comprehensive rehabilitation is crucial for a pain-free return to play (RTP). Over the past 15 years, platelet-rich plasma (PRP) has emerged for its potential in tissue regeneration.
View Article and Find Full Text PDFAnesthesiology
January 2025
Takeda Development Center Americas, Inc., Lexington, MA, USA.
Background: Orexin neuropeptides help regulate sleep/wake states, respiration, and pain. However, their potential role in regulating breathing, particularly in perioperative settings, is not well understood. TAK-925 (danavorexton), a novel, orexin receptor 2-selective agonist, directly activates neurons associated with respiratory control in the brain and improves respiratory parameters in rodents undergoing fentanyl-induced sedation.
View Article and Find Full Text PDFClin Exp Dent Res
February 2025
Division of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health, Medical University of Graz, Graz, Austria.
Objectives: Considering the importance of patient-centered care, we aimed to evaluate the impact of systemic antibiotics on oral health-related quality of life during nonsurgical periodontal treatment. This controlled trial addresses a gap in understanding how systemic antibiotics influence patient-reported outcomes, focusing on Stage III periodontitis.
Materials And Methods: Sixty-one adults participated in a double-blind, randomized clinical trial, with participants divided into two groups: the test group, which received antibiotics, and the control group.
Hum Vaccin Immunother
December 2025
Clinical Development, Takeda Pharmaceuticals International AG, Zurich, Switzerland.
As infants suffer significant morbidity and mortality due to norovirus-related acute gastroenteritis (AGE), we assessed four formulations of the bivalent virus-like particle (VLP) vaccine candidate (HIL-214) in Panamanian and Colombian infants. 360 infants aged 6 weeks to 5 months were randomly allocated to 8 groups to receive three doses of HIL-214 or two doses of HIL-214 and one dose of placebo (Days 1, 56 and 112), where HIL-214 doses contained 15/15, 15/50, 50/50 or 50/150 μg of GI.1/GII.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!
© LitMetric 2025. All rights reserved.