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Study of Prednisolone effects on treatment and clinical symptoms and laboratory signs of Iranian COVID-19 patients: a clinical trial study

Protocol summary

Study aim
Study of Prednisolone effects on treatment, clinical symptoms and laboratory signs of Iranian COVID-19 patients
Design
This study is a two arm parallel group, double blinded clinical trial in phase 2 which will be carried out on 60 hospitalized ‎COVID-19 patients. Patients randomly divided into two groups.
Settings and conduct
60 hospitalized COVID-19 patients‎ in Shariati, Imam Khomeini, Baharloo and Valiasr hospitals will be included in this study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: COVID-19 patient with Acute Respiratory Distress Syndrome (ARDS) and confirmed by positive PCR test for SARS-CoV-2 or abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities), Blood oxygen saturation <93%, not responding to stamdard COVID-19 treatment after 48-72h. Exclusion criteria: Patients with type I diabetes, asthma and lung diseases, malignancies, kidney and heart failure, uncontrolled high blood pressure, positive pro-calcitonin and active infection, patients taking immunosuppressive drugs and corticosteroids, pregnant or lactating women, prescribing antibiotics due to a bacterial infection
Intervention groups
Control group: Will receive standard treatment for COVID-19 disease. Prednisolone group: In addition to standard treatment will received 0.5mg/kg prednisolone in three divided doses up to 30 mg per day for 5-7 days.
Main outcome variables
Radiographic features findings, Mortality rate, O2 saturation, Need for an oxygen therapy and Laboratory tests

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20081027001411N3
Registration date: 2020-06-01, 1399/03/12
Registration timing: registered_while_recruiting

Last update: 2020-06-01, 1399/03/12
Update count: 0
Registration date
2020-06-01, 1399/03/12
Registrant information
Name
Ahmad Reza Jamshidi
Name of organization / entity
Iran Rheumatology Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 4136
Email address
jamshida@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-29, 1399/01/10
Expected recruitment end date
2020-06-30, 1399/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Prednisolone effects on treatment and clinical symptoms and laboratory signs of Iranian COVID-19 patients: a clinical trial study
Public title
Effect of Prednisolone on treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 patient with Acute Respiratory Distress Syndrome (ARDS) and confirmed by positive PCR test for SARS-CoV-2 or confirmed by abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities), With blood oxygen saturation <93%, Not responding to stamdard COVID-19 treatment after 48-72h
Exclusion criteria:
A history of type I diabetes, asthma and lung diseases, malignancies, kidney and heart failure, uncontrolled high blood pressure, positive pro-calcitonin and active infection Taking immunosuppressive drugs and corticosteroids Pregnant or lactating women Prescribing antibiotics due to a bacterial infection
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block Balanced Randomization Method will be used. Patients will allocate to two groups with Block Balanced Randomization Method. The size of each random block is 2, and patients will be allocated equally to the two intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study patients don't know which group of patients will use the ‎medicine. Physician and clinicians team know about the drug and group who use the drug.‎
Placebo
Not used
Assignment
Parallel
Other design features
This study will be carried out on 60 hospitalized ‎COVID-19 patients. Patients randomly divided into two groups: control group and treatment group ‎which received 0.5mg/kg prednisolone in three divided doses up to 30 mg per day for 5-7 days. Clinical signs of patient including ‎heart rate, blood pressure ‎ body temperature, O2 saturation, CT scan findings, laboratory tests result ‎‎(CBC, ESR, CRP, Ferritin, Troponin, D-dimer) will be recorded before treatment ‎‎and at day 8 and day 14). In addition, Patients' mortality rates, length of hospitalization, and the need for mechanical ventilation and intubation are recorded in two groups of intervention and control.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs Tehran University of Medical Science
Street address
Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2020-03-27, 1399/01/08
Ethics committee reference number
IR.TUMS.VCR.REC.1399.055

Health conditions studied

1

Description of health condition studied
COVID-19 disease
ICD-10 code
U07.2, U07
ICD-10 code description
COVID-19

Primary outcomes

1

Description
Radiographic features findings
Timepoint
Before treatment with Prednisolone and at days 8 and 14 after treatment
Method of measurement
CT scan

2

Description
Mortality rate
Timepoint
Before and after treatment with Prednisolone
Method of measurement
Observation

3

Description
O2 saturation
Timepoint
Before treatment with Prednisolone and at days 8 and 14 after treatment
Method of measurement
Pulse Oximeter

4

Description
Need for an oxygen therapy
Timepoint
Before treatment with Prednisolone and at days 8 and 14 after treatment
Method of measurement
Clinical

Secondary outcomes

1

Description
CBC laboratory test
Timepoint
Before treatment with Prednisolone and at days 8 and 14 after treatment
Method of measurement
Para-clinical

2

Description
ESR laboratory test
Timepoint
Before treatment with Prednisolone and at days 8 and 14 after treatment
Method of measurement
Para-clinical

3

Description
CRP laboratory test
Timepoint
Before treatment with Prednisolone and at days 8 and 14 after treatment
Method of measurement
Para-clinical

4

Description
Ferritin laboratory test
Timepoint
Before treatment with Prednisolone and at days 8 and 14 after treatment
Method of measurement
Para-clinical

5

Description
D-Dimer laboratory test
Timepoint
Before treatment with Prednisolone and at days 8 and 14 after treatment
Method of measurement
Para-clinical

6

Description
Troponin laboratory test
Timepoint
Before treatment with Prednisolone and at days 8 and 14 after treatment
Method of measurement
Para-clinical

Intervention groups

1

Description
Intervention group: Patients hospitalized with COVID-19 disease who in addition to their standard treatment will received 0.5mg/kg prednisolone in three divided doses up to 30 mg per day for 5-7 days.
Category
Treatment - Drugs

2

Description
Control group: Patients hospitalized with COVID-19 disease who are received standard treatment.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati‎ Hospital
Full name of responsible person
Mohammad Abdolahi
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1313514117
Phone
+98 21 8822 0065
Email
sahab.abdollahi@gmail.com

2

Recruitment center
Name of recruitment center
Imam khomeini Hospital‎
Full name of responsible person
Maryam Edalatifard
Street address
mam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1594
Email
M-edalatifatd@tums.ac.ir

3

Recruitment center
Name of recruitment center
Baharloo Hospital
Full name of responsible person
Sasan Falahi
Street address
Baharloo Hospital, Behdari St, Railway Sq
City
Tehran
Province
Tehran
Postal code
12299
Phone
+98 21 5565 8500
Email
sfallahi@sina.tums.ac.ir

4

Recruitment center
Name of recruitment center
Vali Asr Subspecialty Hospital
Full name of responsible person
Mahdi Vojdanian
Street address
Tehran Province, Tehran, District 1, Valiasr St
City
Tehran
Province
Tehran
Postal code
1996714431
Phone
+98 21 8877 0022
Email
vojdanian@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
‎1416753955‎
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ahmadreza Jamshidi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1313514117
Phone
+98 21 8822 0065
Email
jamshida@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Mahmoudi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1313514117
Phone
+98 21 8822 0065
Email
mahmoudim@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Akhtari
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8822 0067
Email
m.akhtari@ut.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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
It will be published as an article
When the data will become available and for how long
After printing the article
To whom data/document is available
All medical professionals and scientiscts
Under which criteria data/document could be used
There is no restriction on access to information
From where data/document is obtainable
Dr. Ahmadreza Jamshidi, Tehran University of Medical Science
What processes are involved for a request to access data/document
Refer to the project supervisor
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