Evaluation of the pharmacological effect of Favipiravir in reducing mortality and improving oxygenation
Design
Patients admitted to the intensive care unit with a pao2 to fio2 ratio of less than 300 and having a bilateral infiltration in the chest x ray were included in the plane. And oxygenation and chest x ray and symptoms of the disease including fever and headache were recorded And in case of death or discharge, a note was made
Settings and conduct
Patients admitted to the intensive care unit, as soon as they entered the plan, entered the study and were treated if they were satisfied.
Participants/Inclusion and exclusion criteria
Entry requirement: age over 18 years
Positive covid patients
The ratio of pao2 to fio2 is below 300
No entry condition:
Dissatisfaction with entering the plan
Intervention groups
Patients with a pao2 to fio2 ratio of less than 300 and who have bilateral infiltration in the chest x ray were included in the study. On the first day, 3200 mg for first day and 1600 mg of the drug were given twice daily in the morning and evening for seven days. Chest x ray and symptoms of the disease, including fever and headache, were recorded
Positive covid patients
Patients with a pao2 to fio2 ratio below 300
Age over 18 years
Exclusion criteria:
Lack of desire to enter the plan
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Street address
End of Niavaran, Darabadational , Research and Treatment center.
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-04-07, 1399/01/19
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.041
Health conditions studied
1
Description of health condition studied
covid positive
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
oxygenation
Timepoint
Up to 10 consecutive days
Method of measurement
pulse Oximetry
Secondary outcomes
1
Description
mortality
Timepoint
Completion of treatment
Method of measurement
death
Intervention groups
1
Description
Intervention group:Patients with a pao2 to fio2 ratio of less than 300 and who have bilateral infiltration in the chest x ray were included in the study. On the first day, 3200 mg for first day and 1600 mg of the drug were given twice daily in the morning and evening for seven days. Chest x ray and symptoms of the disease, including fever and headache, were recorded
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Seyyed Mohammadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2265
Email
iran.criticalcare@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
DR Reza Masoodi
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2912 3100
Email
iran.criticalcare@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Masih Daneshvari Hospital
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
Seyed Mohammad Reza Hashemian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 21 2610 9512
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Hashemian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital,Darabad,Shahid Bahonar Street,Tehran,iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 912 111 9279
Fax
Email
iran.criticalcare@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Hashemian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Dara'abad Street, Niavaran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 21 2712 2265
Fax
Email
iran.criticalcare@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All patient information can be published after deleting the name
When the data will become available and for how long
It will take a month from the time of application
To whom data/document is available
All professors of medical universities in the country
Under which criteria data/document could be used
Help advance science
From where data/document is obtainable
professor hashemian in masih daneshvari hospital
What processes are involved for a request to access data/document