A Phase 3 interventional study of Ixekizumab and Aldesleukin in Covid19, sponsored by University of Sao Paulo. Completed at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-28.
Sponsored by University of Sao Paulo · Phase 3, Interventional, and Treatment
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.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Pneumonia confirmed by chest imaging and
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:
Patients will receive study medication Ixekizumab 80 mg per week, (SC) once a week for 4 weeks or until discharge.
Biological: Ixekizumab
1.5 million IU per day (SC) for 7 days or until discharge. Patients will receive study medication Aldesleukin 1.5 million IU per day (SC), for 7 days or until discharge.
Biological: Aldesleukin
Patients will receive study medication colchicine 0.5 mg every 8 hours for 3 days (PO), followed by 4 weeks (+/-7 days) 0.5 mg twice daily. If a dose is missed, it should not be replaced.
Drug: Colchicine
Standard treatment, supplementation of O2 ventilation + standard treatment of the institution, which may include Dexamethasone according to the institutional protocol.
Drug: Standard of care (SOC)
80 mg of IL-17 inhibitor
Also known as: Taltz
1.5 million IU (low-dose) of IL-2
Also known as: Proleukin
0.5 mg of indirect IL-6 inhibitor
Active comparator (Corticoids and antiretrovirals)
Ordinal scale of seven World Health Organization (WHO) categories of IL-17 inhibitor versus low dose IL-2 versus indirect IL-6 inhibitor (colchicine) versus standard treatment in the treatment of severe COVID-19
proportion of patients with clinical improvement, defined by an increase of two points in the ordinal scale of seven WHO categories
Time frame: On the 21st day of study, since inclusion.
Time until independence from oxygen therapy in days
Time frame: During the follow-up period (30 days (+/- 2))
Ventilator free days (in days)
Time frame: During the follow-up period (30 days (+/- 2))
Assessment of worsening pulmonary involvement, defined as the presence of one of these criteria (absence or presence)
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: At some point in Day 7, Day 14 and Day 28
In patients who needed mechanical ventilation, time to indicate mechanical ventilation
(calculated in days, from entry into the protocol until orotracheal intubation, up to 45 days)
Time frame: Day 0 up to 45 days
Duration of hospitalization, in survivors
In days
Time frame: On day 28
Analysis of in-hospital mortality
Time frame: Day 0 up to 45 days
Analysis of general mortality
Time frame: During the follow-up period (30 days (+/- 2))
Correlation among the inflammatory proteins D-dimer, C- reactive protein (CRP), Lactate Dehydrogenase (LDH) Test, and ferritin with:
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: During the follow-up period (30 days (+/- 2))
Changes from baseline of cytokine storm surrogate markers: white blood counts, lymphocyte counts, neutrophils counts, C-Reactive protein (CRP), ferritin (if applicable), D-dimer (if applicable)
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: at Day 0, Day 2, Day 4, Day 7, Day 14, Day 21 and Day 28 after randomization;
Change in Score for Sepsis (SOFA score)
Time frame: On days 7 and 14 of randomization
Analysis of secondary infections
Time frame: During the follow-up period (30 days (+/- 2))
Qualitative and quantitative assessment of treatment- related adverse effects assessed by the Common Terminology Criteria for Adverse Event (CTCAE) version 5.0.
Time frame: Within the first month
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo