Determining the mortality rate of patients during hospitalization in both groups of pulse methylprednisolone group and 1 mg/per kiloogram of body weight every 12 hours.
Design
The trial has two study groups in parallel, randomized, non-blind phase 3 on 74 patients and uses rand function of excel for randomization
Settings and conduct
Patients with mild to moderate acute respiratory distress syndrome who admit to corona ward of Loghman Hakim hospital will go under study with two different regimen of methylprednisolone doses.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Patients older than 18
Patient with severe acute respiratory injury with symptoms of novel coronavurus during 10 recent days
Posotive polymerase chain reaction (PCR) test of novel coronavirus or chest CT scan that confirms coronavirus pneumonia
Mild to moderate acute respiratory distress syndrome
No more than 24 hours have passed since their admission.
The patient should not be under invasive mechanical ventilation when entering the study.
Satisfaction to participate in the study.
Exclusion criteria:
Dissatisfaction of the patient or the patient's legal companion.
Pregnancy and lactation.
Chronic hemodialysis
Heart failure
Severe vasoplegic shock
Pulmonary edema due to other pathology like heart failure , cirrhosis , chronic kidney failure
Severe hypoxemia
If patient expires lower than 3 days after beginning of treatment.
Intervention groups
One group recieves 1 mg per kg of methylprednisolone every 12 hours and other one recieve 1000 mg of methyl prednisolone daily for 3 days then keep on with 1 mg per kg every 12 hours.
Main outcome variables
mortality ratio
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130917014693N13
Registration date:2021-11-06, 1400/08/15
Registration timing:prospective
Last update:2021-11-06, 1400/08/15
Update count:0
Registration date
2021-11-06, 1400/08/15
Registrant information
Name
Zahra Sahraei
Name of organization / entity
Faculty of pharmacy, Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
z.sahraei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision the efficacy of 2 regimen of methylprednisolone in patient with acute respiratory distress syndrome due to CVOID-19
Public title
comparision of the two methylprednisolone regimens in patient with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years old
Severe acute respiratory injury with coronavirus infection symptoms during 10 days ago who needed for hospital admission
infection with COVID-19 wich confirmed with nasal RT_PCR test or CT-scan imaging
Mild to moderate acute respiratory distress syndrome
No more than 24 hours have passed since their admission to the study.
The patient should not be under aggressive mechanical respiration when entering the study.
Consent to participate in the study.
Exclusion criteria:
Dissatisfaction of the patient or the patient's legal companion
Pregnancy and lactation
Chronic hemodialysis
Heart failure patients
Severe vasoplegic shock
Pulmonary edema due to other causes like heart failure , cirrhosis, chronic kidney failure
Not administrating corticosteroid more than 24 hours after beginning ARDS
Severe hypoxemia
If the patient expires lower than 3 days after beginning of corticosteroids
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
First, by randomized numbers list, a sequence of random numbers will be selected and patients will be allocated to interventions groups with simple randomization.
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 Shahid Beheshti University of Medical Sciences
Street address
3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2021-06-29, 1400/04/08
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.081
Health conditions studied
1
Description of health condition studied
َAcute respiratory distress syndrome of covid-19 pneumonia
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Mortality ratio of patients with acute respiratory distress syndrome due to covid-19
Timepoint
first of admission and time of discharge
Method of measurement
Counting
Secondary outcomes
1
Description
Determine the need for respiratory support and determine changes to this support
Timepoint
every 24 hours
Method of measurement
Ventilation modality
2
Description
Determine the exact length of hospital stay until discharge
Timepoint
every 24 hours
Method of measurement
Counting number of days
3
Description
Determine the number of patients who need to receive hemoperfusion
Timepoint
Every 24 hours
Method of measurement
Count the number of patients and the frequency of hemoperfusion
4
Description
Determine the number of patients who need to receive other immunosuppressants such as tocilizumab
Timepoint
every 24 hours
Method of measurement
Counting the number of patients and the number of doses of other drugs
Intervention groups
1
Description
Intervention group: 1000 miligrams of methylprednisolone every 24 hours for 3 days then 1 mg/kg of methylprednisolone every 12 hours for total of 10 days
Category
Treatment - Drugs
2
Description
Intervention group: methylprednisolone 1 mg/kg every 12 hours for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Zahra sahraei
Street address
Loghman Hakim hospital , Makhsous Ave. , south Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 5541 9005
Email
lhmc@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sahraei
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Shahid Beheshti University of Medical Sciences, Valieasr St, Niyayesh Highway,
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Fax
+98 21 8887 3704
Email
z.sahraei@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sahraei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Valieasr St, Niyayesh Highway, Shahid Beheshti University of Medical Sciences, School of Pharmacy
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Fax
+98 21 8887 3704
Email
z.sahraei@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sahraei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Shahid Beheshti University of Medical Sciences, Valieasr St, Niyayesh Highway,
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Fax
+98 21 8887 3704
Email
z.sahraei@sbmu.ac.ir
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available