Ixekizumab
Biological80 mg of IL-17 inhibitor
Other names: Taltz
NCT Number: NCT04724629
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Faculdade de Medicina de Ribeirão Preto - USP, Ribeirão Preto, São Paulo, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
IMPORTANT: The presence of increased respiratory rate or desaturation (items "a" and "b") are criteria for hospital admission. Items "c" to "g" are considered criteria for ICU admission
Following the recommendations of The São Paulo State Health Secretariat, resolution SS-28 of 03-Mar-2020, prepared by the Hospital das Clínicas of Medical School-USP.
Exclusion criteria
80 mg of IL-17 inhibitor
Other names: Taltz
1.5 million IU (low-dose) of IL-2
Other names: Proleukin
0.5 mg of indirect IL-6 inhibitor
Active comparator (Corticoids and antiretrovirals)
Time frame: On the 21st day of study, since inclusion.
proportion of patients with clinical improvement, defined by an increase of two points in the ordinal scale of seven WHO categories
Time frame: During the follow-up period (30 days (+/- 2))
Time frame: During the follow-up period (30 days (+/- 2))
Time frame: At some point in Day 7, Day 14 and Day 28
Need to increase the inspired fraction of O2 (FIO2) to keep oxygen saturation stable or the need for mechanical ventilation; b. Increase in the number and / or extension of affected lung areas on chest computed tomography.
Time frame: Day 0 up to 45 days
(calculated in days, from entry into the protocol until orotracheal intubation, up to 45 days)
Time frame: On day 28
In days
Time frame: Day 0 up to 45 days
Time frame: During the follow-up period (30 days (+/- 2))
Time frame: During the follow-up period (30 days (+/- 2))
7 points WHO original scale; b. Time until independence from oxygen therapy; c. Need for mechanical ventilation; d. Days free of mechanical ventilation; e. Mortality
Time frame: at Day 0, Day 2, Day 4, Day 7, Day 14, Day 21 and Day 28 after randomization;
Changes from baseline of cytokine storm surrogate markers: white blood counts, lymphocyte counts, neutrophils counts, CRP, ferritin (if applicable), D-dimer (if applicable)
Time frame: On days 7 and 14 of randomization
Time frame: During the follow-up period (30 days (+/- 2))
Time frame: Within the first month
University of Sao Paulo
Other
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
Acronym: STRUCK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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