Status:
UNKNOWN
Study Design of the Diacerein in Patients With Covid-19
Lead Sponsor:
University of Campinas, Brazil
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Study Design This is a randomized, placebo-controlled, double-blind trial pilot study designed to verify whether diacerein attenuates systemic inflammatory response in hospitalized patients with COVID...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 8 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05226754
Start Date
April 1 2022
End Date
July 8 2023
Last Update
August 2 2022
Active Locations (2)
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1
Unicamp Clinical Hospital
Campinas, São Paulo, Brazil, 13083-888
2
Hospital Estadual Sumaré
Sumaré, São Paulo, Brazil, 13175-490