NCT04909918

Brief Summary

we designed this study to observe the efficacy and safety of dexamethasone versus methylprednisolone in covid-19 diseased patients upon monitoring the inflammatory response and to compare the outcome when these steroids will be given in covid-19 diseased patients in our ICU.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 covid19

Timeline
Completed

Started May 2021

Shorter than P25 for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

May 30, 2021

Last Update Submit

September 4, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Neutrophil/lymphocyte ratio (NLR)

    Monitoring of systemic inflammation by follow up of neutrophil/lymphocyte ratio (NLR) at days 0, 48 hour, 72 hour and at day 7 between the two study drugs

    7 days

Secondary Outcomes (5)

  • Interleukin-6 (IL-6) level

    7days

  • C-reactive protein (CRP) test

    3 days

  • Arterial oxygen tension/ inspired oxygen fraction (P/F ratio)

    3 days

  • ICU stay

    7 days

  • ICU mortality

    7days

Study Arms (2)

(Group D )Dexamethasone

EXPERIMENTAL

Intravenous dexamethasone 8 mg/day given for 7 days

Drug: Dexamethasone

(Group M) methylprednisolone

EXPERIMENTAL

Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days

Drug: Methylprednisolone

Interventions

DexamethasoneDRUG

Baseline laboratory \& clinical data will be taken before and after the study drugs according to our protocol.Intravenous dexamethasone 8 mg/day given for 7 days

Also known as: Decadron
(Group D )Dexamethasone
MethylprednisoloneDRUG

Baseline laboratory \& clinical data will be taken before and after the study drugs according to our protocol. Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days

Also known as: Solu-medrol
(Group M) methylprednisolone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (age 18-no limit years) who will be diagnosed covid-19
  • With destructive inflammatory immune response needing ICU admission to be run on steroid therapy.

You may not qualify if:

  • Severe immunosuppression like HIV (Human immunodeficiency Virus)
  • Long term use of immunosuppressant for any other chronic illness
  • Pregnant or lactating females
  • Patients who are on chronic use of corticosteroids like asthma, rheumatoid arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, Assuit, Assuit universi, Egypt

Location

Related Publications (1)

  • Polidoro RB, Hagan RS, de Santis Santiago R, Schmidt NW. Overview: Systemic Inflammatory Response Derived From Lung Injury Caused by SARS-CoV-2 Infection Explains Severe Outcomes in COVID-19. Front Immunol. 2020 Jun 26;11:1626. doi: 10.3389/fimmu.2020.01626. eCollection 2020.

    PMID: 32714336BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

DexamethasoneCalcium DobesilateMethylprednisoloneMethylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPrednisolone

Study Officials

  • Omar Soliman

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and ICU

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 2, 2021

Study Start

May 28, 2021

Primary Completion

August 15, 2021

Study Completion

August 20, 2021

Last Updated

September 8, 2021

Record last verified: 2021-09

Locations

EG(1)