This October, the National Institutes of Health (NIH) began an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. According to the information that was published, some COVID-19 patients experience an immune response in which the immune system unleashes excessive amounts of proteins that trigger inflammation — called a “cytokine storm” — that can lead to acute respiratory distress syndrome, multiple organ failure and other life-threatening complications.
All these factors leads to the clinical trial aims, such as: can modulating that immune response can reduce the need for ventilators and shorten hospital stays.
Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative expected to involve about 2,100 hospitalized adults with moderate to severe COVID-19 at medical facilities in the United States and Latin America.
“This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” said NIH Director Francis S. Collins, M.D., Ph.D. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.”
During the researches going to be used placebo-controlled trial ACTIV-1 IM. “ACTIV-1 IM is a randomized, placebo-controlled trial that uses an adaptive master protocol. One of the hallmarks of master protocols is that they allow coordinated and efficient evaluation of multiple investigational agents as they become available. This enables maximum flexibility to swiftly weed out drugs that do not demonstrate effectiveness, identify those that do in a short time frame and rapidly incorporate additional experimental agents into the trial,” – NIH commented.
NIH Clinical Trial Three Agents
For the study was chosen three agents. The initial agents are infliximab (REMICADE), developed by Janssen Research & Development, LLC., one of the Janssen Pharmaceutical Companies of Johnson & Johnson; abatacept (ORENCIA), developed by Bristol Myers Squibb; and Cenicriviroc (CVC), an investigational late-stage agent developed by AbbVie. All of these agents consist over 130 immune modulators initially reviewed based on several factors, that including their relevance to COVID-19, strong evidence for use against inflammatory reaction and cytokine storm and availability of large-scale clinical studies.
Volunteers will receive remdesivir, which is the current standard of care treatment of hospitalized patients with COVID-19. “Convalescent plasma and dexamethasone will be allowed at the discretion of the site investigator and in accordance with national guidelines.
They will be randomly assigned to receive a placebo or one of the immune modulators as an add-on treatment. The trial will study the different combination treatment regimens with respect to illness severity, recovery speed, mortality and hospital resource utilization,” – was said in the article.
“The CTSA (NCATS’ Clinical and Translational Science Awards) Program’s nimbleness and innovation in conducting clinical trials—along with the network’s extensive capacity and broad geographical reach—have positioned it to rapidly implement this important trial,” said NCATS (National Center for Advancing Translational Sciences) Director Christopher P. Austin, M.D.
“The innovative trial design will allow efficient evaluation of three different potential COVID-19 treatments concurrently, delivering new possible treatments for patients more quickly and valuable insights into the science of clinical translation.”
To date enrollment is now open, and the trial is expected to last approximately six months.