Evaluation of baricitinib versus dexamethasone for adults hospitalized with COVID-19 in the global ACTT-4 study

September 7, 2022 The global ACTT-4 study, supported by FHI Clinical, evaluated baricitinib vs dexamethasone for adults hospitalized with COVID-19. This trial is the fourth and final stage in a series of phase 3, randomized, double-blind, placebo-controlled trials to evaluate the clinical efficacy and safety of investigational therapeutic agents in hospitalized adults with laboratory-confirmed COVID-19.

Continue ReadingEvaluation of baricitinib versus dexamethasone for adults hospitalized with COVID-19 in the global ACTT-4 study

FHI Clinical to write clinical trial protocol for development of Gb Sciences’ COVID-19-related anti-inflammatory therapies

May 2, 2022 FHI Clinical Inc. announces today it will consult on the go-to-market strategy for COVID-19 related anti-inflammatory therapeutics for Gb Sciences. FHI Clinical will additionally write the draft clinical trial protocol for a first-in-human trial of these proprietary cannabinoid-containing formulations.

Continue ReadingFHI Clinical to write clinical trial protocol for development of Gb Sciences’ COVID-19-related anti-inflammatory therapies

FHI Clinical announces the closing of its acquisition of the clinical trials business of South Africa-based Triclinium Clinical Development (TCD)

February 8, 2022 FHI Clinical Inc. announces today the official closing of its acquisition of the clinical trials business of Triclinium Clinical Development Proprietary Limited (TCD), a full-service, South Africa-based CRO. With the acquisition, FHI Clinical expands its share of the infectious disease (ID) clinical development market and becomes the dominant service provider in sub-Saharan Africa.

Continue ReadingFHI Clinical announces the closing of its acquisition of the clinical trials business of South Africa-based Triclinium Clinical Development (TCD)

FHI Clinical announces intent to acquire South African-based Triclinium Clinical Development (TCD)

December 2, 2021 FHI Clinical announces its intent to acquire TCD Global, a South African-based CRO. The acquisition allows FHI Clinical to expand its share of the infectious disease (ID) clinical development market and become the dominant service provider in sub-Saharan Africa.

Continue ReadingFHI Clinical announces intent to acquire South African-based Triclinium Clinical Development (TCD)

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

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.

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

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.

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

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.

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

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).

Continue ReadingEight sites actively recruiting patients for CYNKCOVID therapy trial

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

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.

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

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

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.

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