AzTrials
AzTrials

COVID-19 PandemicPhase 4NCT05062681

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

A Phase 4 study testing Dexamethasone and Methylprednisolone in people with COVID-19 Pandemic, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19 Pandemic
What is being tested?
Dexamethasone and Methylprednisolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
15 Sep 2021to 15 Mar 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (≥18 years of age) at time of enrolment
  • Present COVID-19 (infection confirmed by RT-PCR or antigen testing)
  • Postive pressure ventilation (non-invasive or invasive) or need supplemental oxygen with non-rebreather mask
  • Admission to ICU in the last 24 hours

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Eman Rostom, BSc contact

01111303366

eman.osama@std.pharma.cu.edu.eg

Dalaal Moustafa Abdallah, Professor contact

01222327743

dalaal.abdallah@pharma.cu.edu.eg

Egypt1 site, 1 recruiting

  • Eman Osama

    Cairo, 11757

    Eman Osama, 01111303366, eman.osama@std.pharma.cu.edu.eg

    Recruiting

Other trials in Egypt

About this study

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

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

Keywords
steroids
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Patients will receive dexamethasone 8 mg q12hours

  • MethylprednisoloneDrug

    Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes

Study groups in NCT05062681
Study groupRoleWhat they receive
Dexamethasone groupActive comparatorPatients will receive dexamethasone 8 mg q12hours
Receives: Drug: Dexamethasone
methylprednisolone groupExperimentalPatients will receive 1mg/kg/day in 2 divided doses over 30 minutes
Receives: Drug: Methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28 days in hospital mortality

    all patients who will die in 28 days from the start of treatment

    Measured: 28 days

Secondary outcomes (4)

  1. WHO clinical progression scale

    WHO clinical progression scale

    Measured: 10 days

  2. Adverse events related to steroids

    incidence of infection or hyperglycemia

    Measured: 10 days

  3. Duration of ICU stay

    Duration of ICU stay

    Measured: 10 days

  4. Duration of high oxygen supplementation

    Duration of high oxygen supplementation

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2021
  2. Study start15 Sep 2021
  3. Primary completion15 Dec 2021 (estimated)
  4. Study completion15 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
RANDOMIZED CONT
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05062681
Sponsor's protocol ID
Steroids in COVID-19
Status last verified
Sep 2021
First submitted
24 Sep 2021
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

    PubMed 32091533

  • Zhang J, Xie B, Hashimoto K. Current status of potential therapeutic candidates for the COVID-19 crisis. Brain Behav Immun. 2020 Jul;87:59-73. doi: 10.1016/j.bbi.2020.04.046. Epub 2020 Apr 22.

    PubMed 32334062

  • Ye Q, Wang B, Mao J. The pathogenesis and treatment of the ;Cytokine Storm' in COVID-19. J Infect. 2020 Jun;80(6):607-613. doi: 10.1016/j.jinf.2020.03.037. Epub 2020 Apr 10.

    PubMed 32283152

  • Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.

    PubMed 32167524

  • 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.

    PubMed 32678530

  • Villar J, Ferrando C, Martinez D, Ambros A, Munoz T, Soler JA, Aguilar G, Alba F, Gonzalez-Higueras E, Conesa LA, Martin-Rodriguez C, Diaz-Dominguez FJ, Serna-Grande P, Rivas R, Ferreres J, Belda J, Capilla L, Tallet A, Anon JM, Fernandez RL, Gonzalez-Martin 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.

    PubMed 32043986

  • 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.

    PubMed 26508525

  • 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, Davi 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.

    PubMed 33072814

  • 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.

    PubMed 33194485

  • 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. No abstract available.

    PubMed 33975548

  • Chen L, Lou J, Bai Y, Wang M. COVID-19 Disease With Positive Fecal and Negative Pharyngeal and Sputum Viral Tests. Am J Gastroenterol. 2020 May;115(5):790. doi: 10.14309/ajg.0000000000000610. No abstract available.

    PubMed 32205644

  • Bartel DP. MicroRNAs: target recognition and regulatory functions. Cell. 2009 Jan 23;136(2):215-33. doi: 10.1016/j.cell.2009.01.002.

    PubMed 19167326

  • 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.

    PubMed 28261201

  • 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.

    PubMed 32526370

  • 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.

    PubMed 33221169

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone and Methylprednisolone in people with COVID-19 Pandemic, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eman Rostom, BSc (01111303366, eman.osama@std.pharma.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28 days in hospital mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05062681, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in