COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05226754

Alejandro R Castillo, MD.PHD

aleroselldr@gmail.com

2022-02-07

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: adult patients of either sex (≥18 years of age) with a diagnosis of covid-19 infection, confirmed by positive polymerase chain reaction pcr reaction. patient or his/her legal representative provide written informed consent prior to the start of the study.

patients already hospitalized and on mechanical ventilation for over 48 hours; pregnant or breastfeeding women; contraindication for the use of diacerein or history of diacerein hypersensitivity; end-stage renal disease requiring renal replacement therapy; chronic liver disease and/or alt and ast ≥5 times the normal upper reference limit; any active underlying malignancy; currently enrolled in another research study; peripheral capillary oxygen saturation/fraction of inspired oxygen ratio <100; use of high dose of >1.0 mcg/kg/min of norepinephrine or need for rescue therapy with vasopressin; bacterial or fungal infection, except for mild cutaneous infection or sinus infection. any condition which, in the opinion of the investigator, places the patient at unacceptable risk if they were to participate in the study; clinically relevant serious co-morbid medical conditions including, but not limited to, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, severe hepatic impairment, active central nervous system (cns) disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (hiv), active hepatitis b or c, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements; treatment with any immunosuppressive therapy other than corticosteroids within 30 days prior to screening;

2

University of Campinas, Brazil

18

100

Brazil

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

40

Serum levels of cytokines, troponin-T and D-dimer

None

Phase 2

[{"arm_notes": "", "treatment_id": 2152, "treatment_name": "Diacerein", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]