Coronavirus infection, unspecified
Conditions
Interventions
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 o
Drug
Sponsors
Pesquisador
Novartis Biociência S.A.
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Brazil
Contacts
Public ContactGUSTAVO;GUSTAVO RESENDE;RESENDE
Hospital das Clínicas UFMG;Hospital das Clínicas UFMG
Outcome results
None listed