NCT04724629

Survival TRial Using CytoKines in COVID-19 (STRUCK Trial)

Prospective-randomized Adaptive Study, With Active Control to Evaluate the Efficacy and Safety of Interleukin (IL)-17 Inhibitor Treatment Versus Low Doses of IL-2 Versus Indirect IL-6 Inhibitor in Hospitalized Patients With Severe Forms of COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	Ixekizumab	80 mg of IL-17 inhibitor
BIOLOGICAL	Aldesleukin	1.5 million IU (low-dose) of IL-2
DRUG	Colchicine	0.5 mg of indirect IL-6 inhibitor
DRUG	Standard of care (SOC)	Active comparator (Corticoids and antiretrovirals)

Timeline

• Start date: 2021-01-05
• Primary completion: 2021-03-31
• Completion: 2021-07-30
• First posted: 2021-01-26
• Last updated: 2022-07-28

Locations

2 sites across 1 country: Brazil

Regulatory

• FDA-regulated drug study