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Study Design of the Diacerein in Patients With Covid-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05226754
Recruitment Status : Recruiting
First Posted : February 7, 2022
Last Update Posted : August 2, 2022
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Andrei Carvalho Sposito, University of Campinas, Brazil

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 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).

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Diacerein Drug: placebo capsules Phase 2

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After enrolment, patients will be randomized (n=20 per group) 1:1 to receive either diacerein 50 mg or placebo treatment every 12 hours for 10 days. The research electronic data capture (REDCap) platform will be used as a randomization system. Patients, investigators and other support staff will be blinded to the experimental therapy. The study drug, diacerein (Artrodar®-capsules 50mg) and placebo capsules (lactose and magnesium stearate), will be similar in size and appearance to maintain blinding. All laboratory analyses will be performed blinded to the treatment. Identification of the study drug will only occur after locking the dataset.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study Design of the Diacerein Effect on Inflammatory Response in Patients With Covid-19: a Randomized, Placebo-controlled, Double-blind Trial.
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : July 8, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GROUP A
diacerein 50 mg (capsules) every 12 hours for 10 days
Drug: Diacerein
After enrolment, patients will be randomized (n=20 group A) to receive diacerein capsules 50 mg every 12 hours for 10 days.
Other Name: Artrodar®-capsules 50mg

Placebo Comparator: GROUP B
placebo capsules (lactose and magnesium stearate)
Drug: placebo capsules
After enrolment, patients will be randomized (n=20 group A) to receive placebo capsules (lactose and magnesium stearate) every 12 hours for 10 days.
Other Name: lactose and magnesium stearate




Primary Outcome Measures :
  1. Serum levels of cytokines, troponin-T and D-dimer [ Time Frame: Day 0, Day 2, Day 5, Day 10 ]
    The endpoints are the change in the serum levels of cytokines, troponin-T and D-dimer from Day 0 to Day 5 of hospitalization, and from Day 0 to Day 10, as well as the area under the curve considering all measurements from Day 0 to Day 10.


Secondary Outcome Measures :
  1. Time to clinical deterioration [ Time Frame: Day 0 to Day 10 ]
    Defined as time from randomization to mortality or worsening of the World Health Organization (WHO) Clinical Progression Scale, assessed by the increase of two points in this scale.

  2. Adverse events [ Time Frame: Day 0 to Day 10 ]
    Cumulative incidence of adverse events

  3. Severe adverse events [ Time Frame: Day 0 to Day 10 ]
    Cumulative incidence of severe adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05226754


Contacts
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Contact: Alejandro R Castillo, MD.PHD +55 (19) 35219580 aleroselldr@gmail.com

Locations
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Brazil
Unicamp Clinical Hospital Recruiting
Campinas, São Paulo, Brazil, 13083-888
Contact: Alejandro Rosell Castillo    +551935219580    aleroselldr@gmail.com   
Principal Investigator: Andrei Sposito         
Hospital Estadual Sumaré Recruiting
Sumaré, São Paulo, Brazil, 13175-490
Contact: Alejandro Rosell Castillo    1935219580    aleroselldr@gmail.com   
Principal Investigator: Andrei Sposito         
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Andrei C Sposito, MD.PHD State University of Campinas, Campinas, Brazil
Publications of Results:
Huang M, Zong S-l and Zhang Q-y. The effect of food intake on the pk of rhein released from diacerein. Brazilian Journal of Pharmaceutical Sciences. 2020;56.

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Responsible Party: Andrei Carvalho Sposito, Director, Brazilian Heart Study Group, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT05226754    
Other Study ID Numbers: 50440921.6.0000.5404
First Posted: February 7, 2022    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrei Carvalho Sposito, University of Campinas, Brazil:
COVID-19
Diacerein
Inflammatory Cytokine
Clinical Trial
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Diacerein
Anti-Inflammatory Agents