RCT on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow

COVID-19 Pandemic Clinical Trial

Official title:

Randomized Controlled Trial on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05062681
• Other study ID #: Steroids in COVID-19
• Status: Recruiting
• Phase: Phase 4
• Start date: September 15, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: Eman Rostom, BSc
• Phone: 01111303366
• Email: eman.osama[@]std.pharma.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the therapeutic activity and side effects of 16 mg/day dexamethasone in comparison to equivalent dose of MP (1mg/kg/day)for the management of COVID-19 infected patients.Moreover, and according to the importance of the IL-6/STAT-3 in triggering the inflammatory cascade and as the miRNAs are considered as prognostic markers, hence, the study aims also to study the impact of the used regimens on these biomarkers

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 15, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult (=18 years of age) at time of enrolment

2. Present COVID-19 (infection confirmed by RT-PCR or antigen testing)

3. Postive pressure ventilation (non-invasive or invasive) or need supplemental oxygen with non-rebreather mask

4. Admission to ICU in the last 24 hours

Exclusion Criteria:

• 1- Underlying disease requiring chronic corticosteroids 2- Any dose of dexamethasone during the present hospital stay for COVID-19 for =5 days before enrollment 3- Systemic corticosteroids during present hospital stay for conditions other than COVID-19 (e.g. septic shock) 4-Any contraindication for corticosteroid administration 5-Cardiac arrest before ICU admission 6-Pregnancy or breast feeding 7- Immunocompromised patients as cancer (active) patients, patients on chemotherapy or radiotherapy, HIV, and transplant patients

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Intervention

Drug:
• Dexamethasone
Patients will receive dexamethasone 8 mg q12hours
• Methylprednisolone
Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes

Locations

Country	Name	City	State
Egypt	Eman Osama	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (22)

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Correia CN, Nalpas NC, McLoughlin KE, Browne JA, Gordon SV, MacHugh DE, Shaughnessy RG. Circulating microRNAs as Potential Biomarkers of Infectious Disease. Front Immunol. 2017 Feb 16;8:118. doi: 10.3389/fimmu.2017.00118. eCollection 2017. Review. — View Citation

Guterres A, de Azeredo Lima CH, Miranda RL, Gadelha MR. What is the potential function of microRNAs as biomarkers and therapeutic targets in COVID-19? Infect Genet Evol. 2020 Nov;85:104417. doi: 10.1016/j.meegid.2020.104417. Epub 2020 Jun 8. — View Citation

Han H, Ma Q, Li C, Liu R, Zhao L, Wang W, Zhang P, Liu X, Gao G, Liu F, Jiang Y, Cheng X, Zhu C, Xia Y. Profiling serum cytokines in COVID-19 patients reveals IL-6 and IL-10 are disease severity predictors. Emerg Microbes Infect. 2020 Dec;9(1):1123-1130. doi: 10.1080/22221751.2020.1770129. — View Citation

Jafarzadeh A, Nemati M, Jafarzadeh S. Contribution of STAT3 to the pathogenesis of COVID-19. Microb Pathog. 2021 May;154:104836. doi: 10.1016/j.micpath.2021.104836. Epub 2021 Mar 7. Review. — View Citation

Li C, Hu X, Li L, Li JH. Differential microRNA expression in the peripheral blood from human patients with COVID-19. J Clin Lab Anal. 2020 Oct;34(10):e23590. doi: 10.1002/jcla.23590. Epub 2020 Sep 22. — View Citation

Liu T, Zhang J, Yang Y, Ma H, Li Z, Zhang J, Cheng J, Zhang X, Zhao Y, Xia Z, Zhang L, Wu G, Yi J. The role of interleukin-6 in monitoring severe case of coronavirus disease 2019. EMBO Mol Med. 2020 Jul 7;12(7):e12421. doi: 10.15252/emmm.202012421. Epub 2020 Jun 5. — View Citation

Meduri GU, Bridges L, Shih MC, Marik PE, Siemieniuk RAC, Kocak M. Prolonged glucocorticoid treatment is associated with improved ARDS outcomes: analysis of individual patients' data from four randomized trials and trial-level meta-analysis of the updated literature. Intensive Care Med. 2016 May;42(5):829-840. doi: 10.1007/s00134-015-4095-4. Epub 2015 Oct 27. Review. — View Citation

Mirzaei R, Mahdavi F, Badrzadeh F, Hosseini-Fard SR, Heidary M, Jeda AS, Mohammadi T, Roshani M, Yousefimashouf R, Keyvani H, Darvishmotevalli M, Sani MZ, Karampoor S. The emerging role of microRNAs in the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Int Immunopharmacol. 2021 Jan;90:107204. doi: 10.1016/j.intimp.2020.107204. Epub 2020 Nov 13. Review. — View Citation

Rana MA, Hashmi M, Qayyum A, Pervaiz R, Saleem M, Munir MF, Ullah Saif MM. Comparison of Efficacy of Dexamethasone and Methylprednisolone in Improving PaO2/FiO2 Ratio Among COVID-19 Patients. Cureus. 2020 Oct 12;12(10):e10918. doi: 10.7759/cureus.10918. — View Citation

Ranjbar K, Moghadami M, Mirahmadizadeh A, Fallahi MJ, Khaloo V, Shahriarirad R, Erfani A, Khodamoradi Z, Saadi MHG. Correction to: Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial. BMC Infect Dis. 2021 May 11;21(1):436. doi: 10.1186/s12879-021-06130-7. — 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, Rowan K, Juszczak E, Baillie JK, Haynes R, Landray MJ. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021 Feb 25;384(8):693-704. doi: 10.1056/NEJMoa2021436. Epub 2020 Jul 17. — View Citation

Salton F, Confalonieri P, Meduri GU, Santus P, Harari S, Scala R, Lanini S, Vertui V, Oggionni T, Caminati A, Patruno V, Tamburrini M, Scartabellati A, Parati M, Villani M, Radovanovic D, Tomassetti S, Ravaglia C, Poletti V, Vianello A, Gaccione AT, Guidelli L, Raccanelli R, Lucernoni P, Lacedonia D, Foschino Barbaro MP, Centanni S, Mondoni M, Davì M, Fantin A, Cao X, Torelli L, Zucchetto A, Montico M, Casarin A, Romagnoli M, Gasparini S, Bonifazi M, D'Agaro P, Marcello A, Licastro D, Ruaro B, Volpe MC, Umberger R, Confalonieri M. Prolonged Low-Dose Methylprednisolone in Patients With Severe COVID-19 Pneumonia. Open Forum Infect Dis. 2020 Sep 12;7(10):ofaa421. doi: 10.1093/ofid/ofaa421. eCollection 2020 Oct. — View Citation

Tomazini BM, Maia IS, Cavalcanti AB, Berwanger O, Rosa RG, Veiga VC, Avezum A, Lopes RD, Bueno FR, Silva MVAO, Baldassare FP, Costa ELV, Moura RAB, Honorato MO, Costa AN, Damiani LP, Lisboa T, Kawano-Dourado L, Zampieri FG, Olivato GB, Righy C, Amendola CP, Roepke RML, Freitas DHM, Forte DN, Freitas FGR, Fernandes CCF, Melro LMG, Junior GFS, Morais DC, Zung S, Machado FR, Azevedo LCP; COALITION COVID-19 Brazil III Investigators. Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial. JAMA. 2020 Oct 6;324(13):1307-1316. doi: 10.1001/jama.2020.17021. — View Citation

Villar J, Ferrando C, Martínez D, Ambrós A, Muñoz T, Soler JA, Aguilar G, Alba F, González-Higueras E, Conesa LA, Martín-Rodríguez C, Díaz-Domínguez FJ, Serna-Grande P, Rivas R, Ferreres J, Belda J, Capilla L, Tallet A, Añón JM, Fernández RL, González-Martín JM; dexamethasone in ARDS network. Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial. Lancet Respir Med. 2020 Mar;8(3):267-276. doi: 10.1016/S2213-2600(19)30417-5. Epub 2020 Feb 7. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 days in hospital mortality	all patients who will die in 28 days from the start of treatment	28 days
Secondary	WHO clinical progression scale	WHO clinical progression scale	10 days
Secondary	Adverse events related to steroids	incidence of infection or hyperglycemia	10 days
Secondary	Duration of ICU stay	Duration of ICU stay	10 days
Secondary	Duration of high oxygen supplementation	Duration of high oxygen supplementation	10 days