Survival TRial Using CytoKines in COVID-19 (STRUCK Trial)
Status:
Recruiting
Trial end date:
2021-07-30
Target enrollment:
Participant gender:
Summary
Currently, there are few approved treatments for COVID-19, antiretroviral (remdesivir) and
corticoids. With about 15% of COVID-19 patients suffering from severe disease health system
will be overwhelmed. Treatments approaches to inhibit viral replication (antiretroviral and
extended spectrum antiviral drugs), such as Remdesivir and Hydroxychloroquine are being used.
In severe cases, by CT scans investigators are able to observe that these patients seem to be
dying with fibrosis and lung vasculitis. It is hypothesised that targeting vasculitis and
lung inflammation secondary to the viral infection may help patients' survival (reducing
mortality) and/or decrease time in mechanical ventilators. It is proposed a 4-arm trial,
converted to 2 after interim analysis (60 patients for the initial phase, sample size
recalculation after initial analysis and 2 arms beyond). In initial phase, IL-6 indirect
inhibitor (colchicine), in first arm; IL-17 inhibitor, an innovative target never tested (at
this moment) in COVID-19 severe patients, in second study arm. Both approaches (indirect IL-6
and Il-17) are related to modulation of inflammatory immune response. Finally, in third arm,
IL-2 low dose. This cytokine was identified as Treg upregulation. Treg levels decrease in
hepatitis C virus (HCV) associated vasculitis and increase in vasculitis resolution. In
fourth arm, control group, standard of care. Initially, for the first 60 included patients,
the study will comprise 4 arms (15 patients per arm, randomization ratio 1:1:1:1). An interim
effectiveness and safety analysis at this point will guide the selection of one single
treatment strategy (adaptative study) to be carried on after that, comparatively with the
control group. The multi-site trial planned enrollment duration of 4-6 months and for each
participant will be approximately 4 weeks. This trial will bring complementary data to the
global effort in COVID-19 cases resolution.
Phase:
Phase 3
Details
Lead Sponsor:
University of Sao Paulo
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico Science Valley Research Institute