The effect of febuxostat on pulmonary complications of COVID-19
Design
This is a double-blind, parallel-controlled clinical trial that will be conducted in two groups of 30 patients referred to coronavirus center.
Settings and conduct
Patients with COVID-19, referred to the coronavirus center of Sari, will receive one intervention if they do not need hospitalization in a double-blind, 30-person group.
Participants/Inclusion and exclusion criteria
This study will be conducted on patients with coronavirus 2019, and critically ill patients who need hospitalization will not be included.
Intervention groups
Intervention group will receive acetaminophen + febuxostat and comparison group will receive acetaminophen + hydroxychloroquine.
Main outcome variables
Fever; Lymphocyte count; CRP; CT scan findings
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190727044343N1
Registration date:2020-04-05, 1399/01/17
Registration timing:retrospective
Last update:2020-04-05, 1399/01/17
Update count:0
Registration date
2020-04-05, 1399/01/17
Registrant information
Name
Lotfollah Davoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4221 8231
Email address
lotfdavoodi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-16, 1398/12/26
Expected recruitment end date
2020-04-02, 1399/01/14
Actual recruitment start date
2020-03-15, 1398/12/25
Actual recruitment end date
2020-03-27, 1399/01/08
Trial completion date
2020-04-09, 1399/01/21
Scientific title
The effect of febuxostat against lung injury induced by COVID-19 virus in infected patients: A clinical trial study
Public title
ٍEffect of febuxostat against coronavirus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients infected with COVID-19
Exclusion criteria:
Severe disease patients that need hospitalization.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with sealed envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient receives the medication (intervention or comparison) in sealed envelopes that are coded. The coding is done by a project colleague and the physician, assessor and patient are blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moallem
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.MAZUMS.REC.1398.1452
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
CT-scan findings
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
CT-scan
Secondary outcomes
1
Description
Fever
Timepoint
Before the intervention and 5 days after the intervention
Method of measurement
Thermometer
2
Description
Lymphocyte count
Timepoint
Before the intervention and 5 days after the intervention
Method of measurement
CBC test
3
Description
CRP
Timepoint
Before the intervention and 5 days after the intervention
Method of measurement
Laboratory
Intervention groups
1
Description
Intervention group: Acetaminophen + Febuxostat
Category
Treatment - Drugs
2
Description
Control group: Acetaminophen + Hydroxychloroquine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Coronavirus center
Full name of responsible person
Lotfollah Davoodi
Street address
Amirmazandarani
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
Email
lotfdavoodi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sceinces
Full name of responsible person
Majid Saeedi
Street address
Moallem
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Email
research@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sceinces
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
Mazandaran University of Medical Sciences
Full name of responsible person
Lotfollah Davoodi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Amirmazandarani
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
lotfdavoodi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Lotfollah Davoodi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Amirmazandarani
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
009833361700
Email
lotfdavoodi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Lotfollah Davoodi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
َAmirmazandarani
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
lotfdavoodi@yahoo.com
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
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
Not applicable
Title and more details about the data/document
SPSS data file can be shared
When the data will become available and for how long
Post Publication
To whom data/document is available
The data will be available to researchers
Under which criteria data/document could be used
Can be used in secondary studies
From where data/document is obtainable
Mail to lotfdavoodi@yahoo.com
What processes are involved for a request to access data/document