Evaluation of early warning systems for clinical assessment of patients with COVID-19 in the global study, ACTT-1

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September 21, 2021 The results from this study provide important information about the clinical management of hospitalized patients with COVID-19. Additional research is needed to identify a method that can be used to accurately prioritize patients with COVID-19 at risk of critical illness or death.

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Tiziana and FHI Clinical enter a collaboration agreement for a phase 2 clinical trial of intranasal Foralumab to treat hospitalized patients with severe COVID-19

June 23, 2021 Tiziana and FHI Clinical announce collaboration on a Phase 2 study in Brazil to evaluate the safety, tolerability and efficacy of intranasal Foralumab in hospitalized patients with severe COVID-19 and pulmonary inflammation.

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Baricitinib + remdesivir superior to remdesivir alone for hospitalized adults with COVID-19: ACTT-2 results published in NEJM

April 24, 2021 Results of the Adaptive COVID-19 Treatment Trial (ACTT)-2 investigating combination treatment with baricitinib, a Janus kinase inhibitor, and remdesivir for the treatment of COVID-19 in hospitalized adults were published in the New England Journal of Medicine (NEJM) on March 4, 2021, showing that the combination treatment was superior to remdesivir alone.

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Eight sites actively recruiting patients for CYNKCOVID therapy trial

March 29, 2021 Phase I/II studies to evaluate human placental hematopoietic stem cell–derived natural killer (NK) cell therapy to treat COVID-19 in hospitalized adults are currently ongoing as part of our partnership with the Infectious Disease Research Institute (IDRI).

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TrialSite News podcast: Patient recruitment challenges for COVID-19 clinical trials

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February 8, 2021 In a recent podcast discussion with TrialSite News, Claudia Christian, Senior Vice President, Clinical Operations at FHI Clinical, shares how the company’s experience in complex clinical research in resource-limited settings helps to ensure health equity and get life-saving vaccines to those who need them most.

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ACTT-2 findings support FDA emergency use authorization for baricitinib + remdesivir to treat COVID-19

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November 20, 2020 The U.S. FDA granted emergency use authorization (EUA) for the use of baricitinib in combination with remdesivir to treat COVID-19 in hospitalized adults and children at least two years of age requiring supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation.

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Building tuberculosis research capacity through the China Tuberculosis Clinical Trials Consortium (CTCTC) network

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October 16, 2020 Development and ongoing activities of the China Tuberculosis Clinical Trials Consortium (CTCTC) were described in an article published in the Infectious Diseases of Poverty journal earlier this year. Read more, including FHI Clinical's role in providing the network with technical support and guidance for clinical trial capacity building.

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FHI Clinical and Oracle bring critical clinical trial capabilities to markets in need

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October 12, 2020 Oracle Health Sciences and FHI Clinical Inc. have joined efforts to improve clinical trial efficiency and help get therapies to market faster. FHI Clinical has adopted Oracle Health Sciences Clinical One for randomization, supply management, and data collection; Oracle Argus Safety for safety case management; Oracle CTMS Cloud Service to manage the entire research portfolio; and Oracle ClearTrial Cloud Service to help budget, plan and bid on projects.

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Remdisivir superior to standard care for hospitalized adults with COVID-19: Final ACTT-1 results published in NEJM

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October 8, 2020 Final results of the Adaptive COVID-19 Treatment Trial (ACTT)-1 investigating remdesivir for the treatment of COVID-19 in hospitalized adults with evidence of lower respiratory tract involvement have been published in the New England Journal of Medicine (NEJM). Of the FHI Clinical study team members, Danielle Fisher, Clinical Research Project Manager, and Wendi McDonald, Associate Project Manager, are listed on the manuscript for their contributions to the study.

Continue ReadingRemdisivir superior to standard care for hospitalized adults with COVID-19: Final ACTT-1 results published in NEJM