Study Design of the Diacerein in Patients With Covid-19

• Status: Not yet recruiting
• Trial end date: 2022-07-08
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, placebo-controlled, double-blind trial pilot study. This study will include individuals over 18 years of age who have been hospitalized with a confirmed diagnosis of COVID-19 to assess whether DIACEREIN treatment is safe and effective in controlling or decreasing inflammation in the body and viral load (amount of virus in the body in these patients).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Campinas, Brazil
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Diacetylrhein

Criteria

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.

Exclusion Criteria:

• 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;