Evaluation of Efficacy of Levamisole and Formoterol+Budesonide in Treatment of COVID-19
NCT ID: NCT04331470
Last Updated: 2020-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2020-04-04
2020-05-20
Brief Summary
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It seems that by three strategy disease can be treated. 1- By using systemic immune simulators. 2- By using topical anti-inflammatory drug in the respiratory system (Steroids or NSAIDs) 3- By inhibition of replication of the virus in the attacked cells.
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Detailed Description
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When ACEII would be blocked by virus level of angiotensin II will be increased and this enzyme along with vasoconstriction, makes cells to manufacture TNF α and IL-6 which are responsible for cytokine storm and Lymphopenia. Also presence of virus and virus shell on the surface of the infected cells make immune system to attack to the respiratory system hence effect of angiotensin II inside the cell causes fibrosis of the respiratory cells. This inflammation and tissue damage make Acute Respiratory Distress syndrome (ARDS) which is lethal for patients. There is a dilemma in treatment of this infection. From one side it doesn't make sense to decrease the immune response hence it will make the infection worse. And from other side stimulation of the immune response because of respiratory inflammation can expedite process of lethal ARDS. A new strategy for treatment of this disease which consists of local anti- inflammatory and systemic immune stimulant drugs can be considered as a reasonable strategy.As immunostimulator, Levamisole can increase Lymphocytes and empower the immunity of the body. This drug can also bind to Papaine Like Protease(PL-pro) of the shell of the virus which is necessary for virulence of COVID-19. It also can decrease level of TNF α and IL-6, and as a chemical adjutant can introduce the virus to the immune system. In addition to Levamisole, Formoterol+Budesonide inhaler can be used in this protocol. Budesonide is a steroid and can suppress the immune reaction locally in the respiratory system. Formoterol is β2 agonist and can open airways. It also can bind to PL-pro and can neutralize the virus according to the published articles.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Levamisole Pill + Budesonide+Formoterol inhaler+Standard care
This group will take Levamisole + Budesonide/Formoterol along side with standard treatment regime.
Levamisole Pill + Budesonide+Formoterol inhaler
Levamisole 50 mg tablet has to be taken 1-2 tablets every 8 hours Budesonide+Formoterol has to be inhaled 1-2 puff every 12 hours
Lopinavir/Ritonavir + hydoxychloroquine
Hydroxy Chloroquine 200mg single dise Lopinavir/Ritonavir 2 tablets every 12 hours
Standard care
This group will take standard treatment regime introduced by Ministry of health.
Lopinavir/Ritonavir + hydoxychloroquine
Hydroxy Chloroquine 200mg single dise Lopinavir/Ritonavir 2 tablets every 12 hours
Interventions
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Levamisole Pill + Budesonide+Formoterol inhaler
Levamisole 50 mg tablet has to be taken 1-2 tablets every 8 hours Budesonide+Formoterol has to be inhaled 1-2 puff every 12 hours
Lopinavir/Ritonavir + hydoxychloroquine
Hydroxy Chloroquine 200mg single dise Lopinavir/Ritonavir 2 tablets every 12 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1. Spo2\<60%
2. Severe respiratory distress
3. Heamodynamic instabilitty
4. Acid base disturbance
5. Severe Anemia Patients with severe hepatic diseases Patients with Nurvous system diseases
15 Years
100 Years
ALL
No
Sponsors
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Fasa University of Medical Sciences
OTHER
Responsible Party
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Dr. Siamack Afazeli
Doctor
Principal Investigators
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Siamack Afazeli
Role: PRINCIPAL_INVESTIGATOR
Fasa University of Medical Sciences
Locations
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Vali-Asr Hospital
Fasa, Fars, Iran
Countries
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Central Contacts
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Facility Contacts
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References
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Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.
Wu C, Liu Y, Yang Y, Zhang P, Zhong W, Wang Y, Wang Q, Xu Y, Li M, Li X, Zheng M, Chen L, Li H. Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods. Acta Pharm Sin B. 2020 May;10(5):766-788. doi: 10.1016/j.apsb.2020.02.008. Epub 2020 Feb 27.
Gruppen MP, Bouts AH, Jansen-van der Weide MC, Merkus MP, Zurowska A, Maternik M, Massella L, Emma F, Niaudet P, Cornelissen EAM, Schurmans T, Raes A, van de Walle J, van Dyck M, Gulati A, Bagga A, Davin JC; all members of the Levamisole Study Group. A randomized clinical trial indicates that levamisole increases the time to relapse in children with steroid-sensitive idiopathic nephrotic syndrome. Kidney Int. 2018 Feb;93(2):510-518. doi: 10.1016/j.kint.2017.08.011. Epub 2017 Oct 18.
Lee KY. Pneumonia, Acute Respiratory Distress Syndrome, and Early Immune-Modulator Therapy. Int J Mol Sci. 2017 Feb 11;18(2):388. doi: 10.3390/ijms18020388.
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
Chen J. [How to understand the histopathology of SARS and coronavirus disease-19 (COVID-19) associated with acute respiratory distress syndrome]. Zhonghua Bing Li Xue Za Zhi. 2020 Apr 8;49(4):289-290. doi: 10.3760/cma.j.cn112151-20200309-00185. Chinese.
Xu H, Zhong L, Deng J, Peng J, Dan H, Zeng X, Li T, Chen Q. High expression of ACE2 receptor of 2019-nCoV on the epithelial cells of oral mucosa. Int J Oral Sci. 2020 Feb 24;12(1):8. doi: 10.1038/s41368-020-0074-x.
Santos RA, Ferreira AJ, Verano-Braga T, Bader M. Angiotensin-converting enzyme 2, angiotensin-(1-7) and Mas: new players of the renin-angiotensin system. J Endocrinol. 2013 Jan 18;216(2):R1-R17. doi: 10.1530/JOE-12-0341. Print 2013 Feb.
Ruiz-Ortega M, Ruperez M, Lorenzo O, Esteban V, Blanco J, Mezzano S, Egido J. Angiotensin II regulates the synthesis of proinflammatory cytokines and chemokines in the kidney. Kidney Int Suppl. 2002 Dec;(82):S12-22. doi: 10.1046/j.1523-1755.62.s82.4.x.
Gullestad L, Aukrust P, Ueland T, Espevik T, Yee G, Vagelos R, Froland SS, Fowler M. Effect of high- versus low-dose angiotensin converting enzyme inhibition on cytokine levels in chronic heart failure. J Am Coll Cardiol. 1999 Dec;34(7):2061-7. doi: 10.1016/s0735-1097(99)00495-7.
Jin HY, Chen LJ, Zhang ZZ, Xu YL, Song B, Xu R, Oudit GY, Gao PJ, Zhu DL, Zhong JC. Deletion of angiotensin-converting enzyme 2 exacerbates renal inflammation and injury in apolipoprotein E-deficient mice through modulation of the nephrin and TNF-alpha-TNFRSF1A signaling. J Transl Med. 2015 Aug 6;13:255. doi: 10.1186/s12967-015-0616-8.
Tikellis C, Thomas MC. Angiotensin-Converting Enzyme 2 (ACE2) Is a Key Modulator of the Renin Angiotensin System in Health and Disease. Int J Pept. 2012;2012:256294. doi: 10.1155/2012/256294. Epub 2012 Mar 20.
Guignabert C, de Man F, Lombes M. ACE2 as therapy for pulmonary arterial hypertension: the good outweighs the bad. Eur Respir J. 2018 Jun 21;51(6):1800848. doi: 10.1183/13993003.00848-2018. Print 2018 Jun. No abstract available.
Meng Y, Li T, Zhou GS, Chen Y, Yu CH, Pang MX, Li W, Li Y, Zhang WY, Li X. The angiotensin-converting enzyme 2/angiotensin (1-7)/Mas axis protects against lung fibroblast migration and lung fibrosis by inhibiting the NOX4-derived ROS-mediated RhoA/Rho kinase pathway. Antioxid Redox Signal. 2015 Jan 20;22(3):241-58. doi: 10.1089/ars.2013.5818. Epub 2014 Oct 2.
Zhang BN, Xu H, Gao XM, Zhang GZ, Zhang X, Yang F. Protective Effect of Angiotensin (1-7) on Silicotic Fibrosis in Rats. Biomed Environ Sci. 2019 Jun;32(6):419-426. doi: 10.3967/bes2019.057.
Jiang F, Yang J, Zhang Y, Dong M, Wang S, Zhang Q, Liu FF, Zhang K, Zhang C. Angiotensin-converting enzyme 2 and angiotensin 1-7: novel therapeutic targets. Nat Rev Cardiol. 2014 Jul;11(7):413-26. doi: 10.1038/nrcardio.2014.59. Epub 2014 Apr 29.
Szefler SJ. Pharmacodynamics and pharmacokinetics of budesonide: a new nebulized corticosteroid. J Allergy Clin Immunol. 1999 Oct;104(4 Pt 2):175-83. doi: 10.1016/s0091-6749(99)70059-x.
Potential inhibitors against papain-like protease of novel coronavirus (COVID-19) from FDA approved drugs ,Rimanshee Arya1, Amit Das1, Vishal Prashar1,*, Mukesh Kumar1, 2,* 1Radiation Biology & Health Sciences Division, Bhabha Atomic Research Centre, Trombay, Mumbai-400085, India 2Homi Bhabha National Institute, Mumbai-400094, India
Nicolau DV, Bafadhel M. Inhaled corticosteroids in virus pandemics: a treatment for COVID-19? Lancet Respir Med. 2020 Sep;8(9):846-847. doi: 10.1016/S2213-2600(20)30314-3. Epub 2020 Jul 30. No abstract available.
Related Links
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Potential inhibitors against papain-like protease of novel coronavirus (COVID-19) from FDA approved drugs
Other Identifiers
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97548
Identifier Type: -
Identifier Source: org_study_id
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