Wednesday, 27 October 2021


COVID R&D Alliance announces first patient enrollment in COMMUNITY Trial

02 December 2020 | News

COMMUNITY is the first platform trial designed and launched by members of the COVID R&D Alliance, a group of more than 20 leading pharmaceutical and biotech companies

Source credit: Shutterstock

Source credit: Shutterstock

Three members of the COVID R&D Alliance - Amgen Inc, Takeda Pharmaceutical Co Ltd and UCB announced the first patient enrolled in the COMMUNITY Trial (COVID-19 Multiple Agents and Modulators Unified Industry Members). COMMUNITY is a randomised, double-blind, placebo-controlled, adaptive platform trial that enables an array of therapeutic candidates to be studied in hospitalised COVID-19 patients.

COMMUNITY is the first platform trial designed and launched by members of the COVID R&D Alliance, a group of more than 20 leading pharmaceutical and biotech companies who are devoting significant time, insights and company resources to speed the development of potential therapies, novel antibodies, and anti-viral therapies for COVID-19 and its related symptoms.

COMMUNITY uses an adaptive design which allows for the addition, removal and simultaneous study of multiple therapeutic candidates during the course of the trial.

COMMUNITY will onboard global sites in the United States, Brazil, Mexico, Russia, South Africa and other countries. COMMUNITY aims to simplify the study of investigational therapies that may result in potential treatment options and address the needs of hospitals in treating patients.

Initial therapies entering into COMMUNITY were selected based upon their potential to suppress or control the immune response or the resulting inflammation. None of these therapies have been approved by the FDA, EMA, or other health authorities for the treatment of COVID-19 or its symptoms and are still investigational. These include:

  • Amgen's OTEZLA® (apremilast), which may suppress immune response inflammation;
  • Takeda's investigational intravenous administration of lanadelumab, which modulates the kallikrein-kinin system and suppresses production of bradykinin, potentially lessening inflammation;
  • UCB's zilucoplan, an investigational medicine that may reduce overactivation of the immune system that contributes to ARDS.

COMMUNITY is studying hospitalised COVID-19 patients. This includes confirmed COVID-19 patients who may require either ongoing medical care, supplemental oxygen, noninvasive ventilation or high-flow oxygen devices, or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). By enrolling both hospitalised Intensive Care Unit and non-Intensive Care Unit patients, the trial seeks to yield greater understanding of how therapeutic interventions may be used with hospitalised COVID-19 patients experiencing a range of symptoms.

 

 

 

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