Survival TRial Using CytoKines in COVID-19 (STRUCK Trial) (STRUCK)
Covid19
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Colchicine, Ixekizumab, Cytokine storm, Lung vasculitis, Recombinant Human Interleukin-2
Eligibility Criteria
Inclusion Criteria:
- Positive result in the quantitative real-time PCR (qPCR) test for SARS-CoV-2 in the respiratory tract;
Pneumonia confirmed by chest imaging and
- Respiratory rate ≥ 24 IRPM (for adults) or
- O2 saturation <93% or
- No improvement in O2 saturation, despite oxygen supply or
- Arterial hypotension; or
- Changes in capillary filling time; or
- Changes in the level of consciousness; or
- Oliguria;
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:
- Age <18 years;
- Refuse to sign the Informed Consent Form;
- Patient's decision that their involvement is not in their interest;
- Severe known liver disease (eg cirrhosis, with aminotransferase levels> 5 times the reference value limit);
- Pregnancy or breastfeeding period;
- Severe bacterial infection;
- Severe diarrhea;
- Diverticulitis or intestinal perforation;
- Infection known as HIV;
- Presence of one of the following uncontrolled or unstable cardiovascular diseases: stroke, ECG confirmed acute ischemia or myocardial infarction and / or clinically significant dysrhythmia; • Known history of gastrointestinal bleeding, uncontrolled peptic ulcer or uncontrolled duodenal ulcer;
- Known history of hemophilia or other bleeding disorders;
- History of organ transplantation, congenital immunodeficiency;
Sites / Locations
- Faculdade de Medicina de Ribeirão Preto - USP
- Hospital e Maternidade Christovão da Gama
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
IL-17 inhibitor (Ixekizumab)
IL-2 (Aldesleukin)
Indirect IL-6 inhibitor (Colchicine)
Standard of care
Patients will receive study medication Ixekizumab 80 mg per week, (SC) once a week for 4 weeks or until discharge.
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.
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.
Standard treatment, supplementation of O2 ventilation + standard treatment of the institution, which may include Dexamethasone according to the institutional protocol.