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

Phase 2

Recruiting

Conditions: Coronavirus infection, unspecified
Coronavirus infections
Severe acute respiratory syndrome (SARS)
Severe Acute Respiratory Syndrome
B34.2
C01.925.782.600.550.200
C01.748.730

Registration Number: RBR-5vpyh4

Lead Sponsor: Pesquisador

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: Not specified

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).

Exclusion Criteria

Functional classes III and IV of congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD); stages 4 and 5 of chronic kidney disease (GFR <30 mL/min); diabetic ketoacidosis; known history of HIV/AIDS infection or chronic or acute HBV or HCV infection; uncontrolled bacterial or fungal co-infections (defined by hemodynamic instability, prior 48h of antimicrobial covering, or at the discretion of the study's medical coordinator); active tuberculosis (TB) infection; history of malignancy in the last year; current users (or in the last 15 days) of immunosuppressants (synthetic or biologic) or corticosteroids (in doses equivalent to or greater than 10mg of prednisone per day); neutrophils count <1000/mm3; pregnancy or breastfeeding (pregnancy test will be performed during the screening period, before the inclusion, in all women of childbearing potential).

Study & Design

Study Type: Intervention

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.