Evaluating the efficacy of methylprednisolone mini pulse therapy on COVID-19 patients admitted to intensive care unit
Design
This study is a two arm parallel non-randomized clinical trial which will be carried out on 60 hospitalized COVID-19 patients.
Settings and conduct
This clinical trial will be carried out on 60 hospitalized COVID-19 patients in Intensive care unit of imam Khomeini hospital of Ardabil university of medical sciences, Iran. Intervention group will receive 250 mg methylprednisolone pulse for 3 days.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients admitted to ICU with moderate to severe Covid-19 infection needs respiratory support, PaO2/FiO2 less than 300, Progression of disease severity and not responding to standard treatment. Exclusion Criteria: Uncontrolled diabetes mellitus, active bleeding, Active bacterial or fungal infection, positive procalcitonin, hypersensitivity to corticosteroids, previous immunosupressor or corticosteroid use.
Intervention groups
Control group will receive standard regimen for COVID-19 and intervention group will receive standard regimen for COVID-19 plus Methylprednisolone 250 mg for 3 days.
Main outcome variables
Changes in respiratory distress, Changes in O2 Saturation, Extubation, Discharge from ICU, Mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170716035126N4
Registration date:2020-08-26, 1399/06/05
Registration timing:retrospective
Last update:2020-08-26, 1399/06/05
Update count:0
Registration date
2020-08-26, 1399/06/05
Registrant information
Name
Afshin Habibzadeh
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3352 2391
Email address
a.habibzade@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-10, 1399/04/20
Expected recruitment end date
2020-08-10, 1399/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of methylprednisolone mini pulse on the treatment of COVID-19 patients admitted to intensive care unit
Public title
The efficacy of methylprednisolone mini pulse on the treatment of COVID-19 patients admitted to intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with moderate to severe Covid-19 admitted to ICU
PaO2/FiO2 Less than 300
Progression of disease severity and not responding to standard treatment
prediction of intubation for next 24 hours or those under mechanical ventilation
Exclusion criteria:
,ncontrolled diabetes mellitus
Active GI bleeding
history of corticosteroid hypersensitivity
sever electrolyte imbalances
History of treatment with immune-suppressor agents
History of corticosteroid use
Positive procalcitonin
active bacterial or fungal infection
HIV and hepatitis
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medicine Sciences, Daneshgah St.,
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2020-06-24, 1399/04/04
Ethics committee reference number
IR.ARUMS.REC.1399.206
Health conditions studied
1
Description of health condition studied
COVID-19 Disease
ICD-10 code
U07.2,
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Mortality rate
Timepoint
from including to study to 60 days
Method of measurement
observation
2
Description
blood O2 saturation
Timepoint
before and during the study for 14 days
Method of measurement
pulse Oximeter
3
Description
oxygen therapy need
Timepoint
before and during the study for 14 days
Method of measurement
Clinical
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with COVID-19 admitted to ICU will receive 250 mg methyl prednisolone in addition to their standard treatment for three days.
Category
Treatment - Drugs
2
Description
Control group: Patients with COVID-19 admitted to ICU will receive standard treatment for COVID-19
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Yousef Mohammadi Kebar
Street address
Imam Khomeini Hospital, Ataei Ave.,
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3352 2083
Email
yousefmk506@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Masoud Entezari Asl
Street address
Ardabil University of Medical Science, Daneshgah St.,
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3352 2083
Email
m.entezari@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Afshin Habibzadeh
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini hospital, Ataei Ave.,
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2391
Email
afshin.habibzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Yousef Mohammadi Kebar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital, Ataei ave.,
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2391
Email
yousefmk506@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Afshin Habibzadeh
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital, Ataei ave.,
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2391
Email
afshin.habibzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available