The effect of methylprednisolone administration on clinical and pulmonary manifestations of COVID-19
Design
This non-blinded clinical trial will be conducted in Shiraz which patients will be enrolled in case and control groups based on their admitted hospital.
Settings and conduct
Tًُُhis study will be conducted in Chamran and Ali-asghar hospitals in Shiraz.This clinical trial will be conducted on 48 patients with COVID-19, in both case and control groups. Patients will receive treatment according to the national protocol and the case group also will receive Methylprednisolone.
Participants/Inclusion and exclusion criteria
Hospitalized patients with confirmed COVID-19 will be included in this study if they fulfilled two primary criteria: age >18 years and PCR documented SARS-CoV-2 carriage in a nasopharyngeal and oropharyngeal sample at admission whatever their clinical status. Patients will be excluded if they have a known contraindication to treatment with the study drug. Breastfeeding and pregnant patients will be excluded based on their declaration and pregnancy test results when required.
Intervention groups
An initial dose of 1mg/kg will be started for all patients in the case group. The patients will receive the mentioned dose for 5 days, which will then be halved for 5 days and repeated until reached a dose of under 20mg/day, which will then be converted into oral tablet form of prednisolone. Also, patients will receive the national treatment protocol for COVID-19.
Main outcome variables
Primary outcome of the study: PAO2/fio2 .
Secondary outcomes of the study: O2 saturation, clinical follow-up and Chest CT findings
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200204046369N1
Registration date:2020-04-08, 1399/01/20
Registration timing:prospective
Last update:2020-04-08, 1399/01/20
Update count:1
Registration date
2020-04-08, 1399/01/20
Registrant information
Name
Keivan Ranjbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 5344
Email address
keivan.rjr94@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-14, 1399/01/26
Expected recruitment end date
2020-06-15, 1399/03/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Methylprednisolone Administration as a Therapeutic Option in the 2019 Novel Coronavirus (COVID-19): A Non-Randomized Controlled Study
Public title
Effect of Methylprednisolone in treatment of COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
RT-PCR documented SARS-CoV-2 carriage in a nasopharyngeal and oropharyngeal sample at admission
Age over 18 years old
Exclusion criteria:
A known contraindication to treatment with the study drug
Breastfeeding and pregnant patients
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
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 Shiraz University of Medical Sciences
Street address
zand street
City
Shiraz
Province
Fars
Postal code
7194815644
Approval date
2020-04-04, 1399/01/16
Ethics committee reference number
IR.SUMS.REC.1399.014
Health conditions studied
1
Description of health condition studied
the 2019 novel Corona virus (COVID-19)
ICD-10 code
U07.1
ICD-10 code description
COVID-19 confirmed by laboratory testing.
Primary outcomes
1
Description
PAO2/fio2
Timepoint
5 days after intervention
Method of measurement
ABG
Secondary outcomes
1
Description
O2 saturation
Timepoint
daily for 7 days
Method of measurement
Pulse oximetry
2
Description
clinical follow-up including vital signs ( temperature, pulse rate, respiratory rate, blood pressure) and laboratory data (CBC and Diff, LFT, BUN, creatinine)
Timepoint
daily for 7 days
Method of measurement
clinical evidences
3
Description
Chest CT findings
Timepoint
1 week after intervention
Method of measurement
Chest CT scan
Intervention groups
1
Description
Intervention group: An initial dose of 1mg/kg will be started for all patients in the case group. The patients will receive the mentioned dose for 5 days, which will then be halved for 5 days and repeated until reached a dose of under 20mg/day, which will then be converted into oral tablet form of prednisolone. Also, patients will receive the national treatment protocol for COVID-19.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group will receive the standard treatment based on the National protocol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Mohammad-Javad Fallahi
Street address
Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Email
Fallahimj@sums.ac.ir
2
Recruitment center
Name of recruitment center
Ali Asghar hospital
Full name of responsible person
Mohsen Moghadami
Street address
Meshkin-fam street
City
Shiraz
Province
Fars
Postal code
7143918796
Phone
+98 71 3228 8907
Email
moghadami@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Moghadami
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
moghadami@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohsen Moghadami
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
moghadami@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohsen Moghadami
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
moghadami@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohsen Moghadami
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
moghadami@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
The study results will be published as an article. The study protocol and statistical analysis used in the article will be considered.
When the data will become available and for how long
It will be published a year after the study is completed and will be available in the sources.
To whom data/document is available
Information will be made available after permission of the sponsor for academic researchers, physicians, and academic institutions .
Under which criteria data/document could be used
Other researchers can use the results of the study in their review and meta-analysis.
From where data/document is obtainable
Dr Moghadami, Department of Internal Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
What processes are involved for a request to access data/document
upon request, the corresponding author will respond after consulting with the sponsor of the study.