COVID-19 Clinical Trial
Official title:
Study Design of the Diacerein Effect on Inflammatory Response in Patients With Covid-19: a Randomized, Placebo-controlled, Double-blind Trial.
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).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | July 8, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
Brazil | Unicamp Clinical Hospital | Campinas | São Paulo |
Brazil | Hospital Estadual Sumaré | Sumaré | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
de Oliveira PG, Termini L, Durigon EL, Lepique AP, Sposito AC, Boccardo E. Diacerein: A potential multi-target therapeutic drug for COVID-19. Med Hypotheses. 2020 Nov;144:109920. doi: 10.1016/j.mehy.2020.109920. Epub 2020 Jun 1. — View Citation
Ferreira AC, Soares VC, de Azevedo-Quintanilha IG, Dias SDSG, Fintelman-Rodrigues N, Sacramento CQ, Mattos M, de Freitas CS, Temerozo JR, Teixeira L, Damaceno Hottz E, Barreto EA, Pão CRR, Palhinha L, Miranda M, Bou-Habib DC, Bozza FA, Bozza PT, Souza TML — View Citation
Fidelix TS, Macedo CR, Maxwell LJ, Fernandes Moça Trevisani V. Diacerein for osteoarthritis. Cochrane Database Syst Rev. 2014 Feb 10;(2):CD005117. doi: 10.1002/14651858.CD005117.pub3. Review. — View Citation
Honvo G, Reginster JY, Rabenda V, Geerinck A, Mkinsi O, Charles A, Rizzoli R, Cooper C, Avouac B, Bruyère O. Safety of Symptomatic Slow-Acting Drugs for Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis. Drugs Aging. 2019 Apr;36(Suppl 1):6 — View Citation
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.
Martel-Pelletier J, Pelletier JP. Effects of diacerein at the molecular level in the osteoarthritis disease process. Ther Adv Musculoskelet Dis. 2010 Apr;2(2):95-104. doi: 10.1177/1759720X09359104. — View Citation
Ragab D, Salah Eldin H, Taeimah M, Khattab R, Salem R. The COVID-19 Cytokine Storm; What We Know So Far. Front Immunol. 2020 Jun 16;11:1446. doi: 10.3389/fimmu.2020.01446. eCollection 2020. Review. — View Citation
RECOVERY Collaborative Group, Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, Staplin N, Brightling C, Ustianowski A, Elmahi E, Prudon B, Green C, Felton T, Chadwick D, Rege K, Fegan C, Chappell LC, Faust SN, Jaki T, Jeffery K, Montgomery A, R — View Citation
Rodrigues TS, de Sá KSG, Ishimoto AY, Becerra A, Oliveira S, Almeida L, Gonçalves AV, Perucello DB, Andrade WA, Castro R, Veras FP, Toller-Kawahisa JE, Nascimento DC, de Lima MHF, Silva CMS, Caetite DB, Martins RB, Castro IA, Pontelli MC, de Barros FC, do — View Citation
Russell CD, Millar JE, Baillie JK. Clinical evidence does not support corticosteroid treatment for 2019-nCoV lung injury. Lancet. 2020 Feb 15;395(10223):473-475. doi: 10.1016/S0140-6736(20)30317-2. Epub 2020 Feb 7. — View Citation
Salama C, Han J, Yau L, Reiss WG, Kramer B, Neidhart JD, Criner GJ, Kaplan-Lewis E, Baden R, Pandit L, Cameron ML, Garcia-Diaz J, Chávez V, Mekebeb-Reuter M, Lima de Menezes F, Shah R, González-Lara MF, Assman B, Freedman J, Mohan SV. Tocilizumab in Patie — View Citation
Singh A, Strobbe D, Campanella M. Pyroptosis targeting via mitochondria: An educated guess to innovate COVID-19 therapies. Br J Pharmacol. 2022 May;179(10):2081-2085. doi: 10.1111/bph.15670. Epub 2021 Oct 10. — View Citation
Tay MZ, Poh CM, Rénia L, MacAry PA, Ng LFP. The trinity of COVID-19: immunity, inflammation and intervention. Nat Rev Immunol. 2020 Jun;20(6):363-374. doi: 10.1038/s41577-020-0311-8. Epub 2020 Apr 28. Review. — View Citation
Vora SM, Lieberman J, Wu H. Inflammasome activation at the crux of severe COVID-19. Nat Rev Immunol. 2021 Nov;21(11):694-703. doi: 10.1038/s41577-021-00588-x. Epub 2021 Aug 9. Review. — View Citation
Yang L, Li J, Xu L, Lin S, Xiang Y, Dai X, Liang G, Huang X, Zhu J, Zhao C. Rhein shows potent efficacy against non-small-cell lung cancer through inhibiting the STAT3 pathway. Cancer Manag Res. 2019 Feb 1;11:1167-1176. eCollection 2019. — View Citation
Yang Y, Peng F, Wang R, Yange M, Guan K, Jiang T, Xu G, Sun J, Chang C. The deadly coronaviruses: The 2003 SARS pandemic and the 2020 novel coronavirus epidemic in China. J Autoimmun. 2020 May;109:102434. doi: 10.1016/j.jaut.2020.102434. Epub 2020 Mar 3. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum levels of cytokines, troponin-T and D-dimer | 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. | Day 0, Day 2, Day 5, Day 10 | |
Secondary | Time to clinical deterioration | 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. | Day 0 to Day 10 | |
Secondary | Adverse events | Cumulative incidence of adverse events | Day 0 to Day 10 | |
Secondary | Severe adverse events | Cumulative incidence of severe adverse events | Day 0 to Day 10 |
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