COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-5vpyh4

GUSTAVO;GUSTAVO RESENDE;RESENDE

gustavogomesresende@yahoo.com.br

2020-07-06

Recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

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).

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).

2

Pesquisador

18

100

Brazil

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

0

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

Phase 2

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