Informal consultation on the potential inclusion of Immunomodulators in a clinical trial - 6 May 2020
Overview
There are several ongoing studies in China, Italy and Spain using immunomodulators therapies. The rational to use these therapies is to reduce the proinflammatory immunoresponse as a complement to the antiviral therapy. The evidence suggests that in severe cases of COVID-19 pneumonia the level of cytokines is very high - what is called the “cytokines storm”- in particular proinflammatory tumor necrosis factor alpha (TNF-α), and interleukin-1 (IL-1) , IL-6 and IL-18. On the contrary, patients with severe COVID-19 demonstrate remarkably impaired IFN-I signatures as compared to mild or moderate cases.
Unfortunately most of the evidence that is available today is not from randomized controlled trials (RCT), most evidence is from compassionate use, case reports and observation studies. Therefore there is a need to study the role of immunomodulators in a RCT