The National Institutes of Health as part of the Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, has launched an adaptive Phase 3 clinical trial to evaluate and determine the safety and efficacy of three immune modulator drugs in hospitalized Covid-19 adult patients.
News: NIH begins large clinical trial to test immune modulators for treatment of COVID-19 https://t.co/RSUl569Qaq
— NIH (@NIH) October 16, 2020
In case of Covid-19, some patients experience an immune response in which the immune system becomes could not check the excessive amounts of proteins that trigger inflammation called a “cytokine storm” as a result of over active immune response, subsequently reducing the recovery time period. It therefore can lead to acute respiratory distress syndrome and multiple organ failure along with other life-threatening complications.
The current rial therefore intends to determine whether the effective modulation of immune response can profoundly reduce the need for ventilators and can it shorten the hospital stays. In April 2020, NIH announced the ACTIV initiative to develop a national research response to prioritize and speed up the development of the most effective Covid-19 therapeutic treatments.
In this Phase II clinical trial, NIH in coordination with the ACTIV-1 trail, expects to recruit over 2,100 moderates to severe Covid-19 hospitalized adult patients at the medical facilities in the United States and Latin America. The ACTIV-1 Immune Modulators (IM) trial , wis responsible to determine if the therapeutics are able to restore balance to an overactive immune system.
In the trial, all patients will be given remdesivir, currently used FDA approved treatment for Covid-19. Convalescent plasma and dexamethasone will be allowed at the discretion of the site investigator and in accordance with national guidelines. Patients will randomly receive the placebo.
The trial aims to study the effects of the different combination treatment regimens with respect to illness severity, recovery speed, mortality and hospital resource utilization. Currently, enrollment is open for the study and the trail is expected to last for up to 6 months with the availability of results shortly after the trials ends. An independent data and safety monitoring board is assigned to ensure the safety and efficacy of the trial.
The NIH Director Francis S. Collins, M.D., Ph.D. while talking to NIH news press, talked about the immune modulators in the trial. He said, “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.”