Use of Anti-IL-17 in patients with Covid-19 associated pneumonia

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2020
INTERVENTION: Antibodies, Monoclonal Drug Experimental group: 25 patients with SARS associated with SARS‐CoV‐2 will receive standard treatment according to the current care protocol (SOC), in addition to an application of Secuquinumab (dose of 300mg) subcutaneously on day 0 (D0 ‐ day of inclusion in the study) and another on the 7th (D7 ‐ 7 days later), if the inclusion and exclusion criteria remain applicable. Control group: 25 patients with SARS associated with SARS‐CoV‐2 will receive only standard treatment according to the current care protocol (SOC). CONDITION: A00‐B99 Coronavirus infection, unspecified Coronavirus infection, unspecified; Coronavirus infections; Severe acute respiratory syndrome (SARS); Severe Acute Respiratory Syndrome ; Coronavirus infection, unspecified ; Coronavirus Infections ; Severe Acute Respiratory Syndrome Coronavirus Infections J00‐J99 Severe Acute Respiratory Syndrome PRIMARY OUTCOME: To assess the ventilator‐free days, under therapy with SECUKINUMAB in addition to standard assistance, as compared with patients under only standard assistance. This outcome will be assessed on day 28 (VFD‐28). VFD‐28 is defined as follow: VFD‐28 = 0 If the patient dies before 28 days. VFD‐28 = (28‐x) If the patient is successfully weaned from mechanical ventilation within 28 days, where x is the number of days spent receiving mechanical ventilation. VFD‐28 = 0 If the patient requires mechanical ventilation for 28 days or more SECONDARY OUTCOME: To evaluate the general efficacy and safety of SECUKINUMAB, compared to standard assistance, through the assessment of the incidence of mortality rate (time frame: 28 days); length of stay in the ICU (time frame: 28 days); length of stay in hospital (time frame: 28 days); Oxygen supplementary‐free days on day 28; WHO Ordinal Scale for Clinical Improvement on day 28; SOFA score (Sequential Organ Failure Assessment; secondary bacterial and fungal infections; major vascular events (Myocardial Infarction / Encephalic Vascular Accident); acute renal failure (doubling of creatinine) or need for hemodialysis; hepatic failure (MELD score); neutropenia (grade 3 ‐ moderate between 500‐1000/mm3; grade 4 ‐ severe <500/mm3); circulatory shock or need for vasopressors (time frame: 28 days); allergic reactions and reactions at the injection site. INCLUSION CRITERIA: Adult patients (age > 18 years); admitted to the Hospital Risoleta Tolentino Neves (HRTN) with SARS‐CoV‐2 infection confirmed by RT‐PCR of oropharyngeal swab or tracheal aspirate; and evolve with fever (at least one measure > 38º C in the last 24h) and severe acute respiratory syndrome (SARS) according to the Brazilian Ministry of Health definition (dyspnea / respiratory discomfort OR persistent chest pressure OR O2 saturation less than 95% in room air OR bluish coloration of the lips or face).
Epistemonikos ID: 47e8c668b6b5711ecded8d5c1c5ee625ab52faa0
First added on: Jul 15, 2020