Comparison of placebo and atorvastatin in improving clinical and laboratory symptoms of hospitalized patients with COVID-19
Design
The study will be conducted as a randomized controlled double-blind clinical trial. 90 patients with coronary infection (confirmed by CT or PCR) will be divided into selected atorvastatin 40 mg tablets once a day in selected hospitals of Qazvin and the control group will receive placebo for 7 days. The obtained results will be analyzed by SPSS software version 25. The quantitative variables will be presented as median ± SD
Settings and conduct
This study will be performed on 90 patients admitted with clinical or paraclinical diagnosis of Covid-19. Based on these criteria, randomly selected patients will be divided into two approximately equal groups.The randomization method will be using random number generation software
Participants/Inclusion and exclusion criteria
Hospitalization in corona-related wards
Confirmation of the disease by CT scan or PCR
No history of liver failure
Intervention groups
They will be divided into two groups receiving atorvastatin 40 mg tablets once a day and the control group receiving placebo for 7 days.
Main outcome variables
Duration of hospitalization; Blood oxygen(sa o2); Intubation; Mortality rate; need of icu
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200906048638N1
Registration date:2021-02-01, 1399/11/13
Registration timing:registered_while_recruiting
Last update:2021-02-01, 1399/11/13
Update count:0
Registration date
2021-02-01, 1399/11/13
Registrant information
Name
rozita bahadori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 3036
Email address
bahadorirozana@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Atorvastatin on 90 patients in-hospital outcome of COVID-19 infection in boali hospital of Qazvin
Public title
Efficacy of Atorvastatin on in-hospital outcome of COVID-19 infection
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization in corona-related wards
Confirmation of the disease by CT scan or PCR
No history of liver failure
Exclusion criteria:
Having non-pulmonary fungal and bacterial infections (non-pulmonary, infectious bed sores, etc.)
Lack of patient consent to participate in the study
Receive treatments other than chloroquine, azithromycin and ceftriaxone
History of receiving statins
Hypersensitivity reaction or any contraindication to the use of atorvastatin
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this trial, random sequence generation software was used for randomization. In this way, information such as sample size and number of groups is given to the software and the software provides a table of random numbers, each of which is randomly assigned the letters A and B. The output of the male is a table, in which 90 people are randomly placed in groups A and B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients included in the study did not know how to give placebo and the main drug, and only how to work and obtain consent to participate in the study were explained to them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
naderi,boalisina hospital
City
qazvin
Province
Qazvin
Postal code
3413786167
Approval date
2020-08-15, 1399/05/25
Ethics committee reference number
ir.qums.rec.1399.171
Health conditions studied
1
Description of health condition studied
coronavirus/ststin
ICD-10 code
U07.1
ICD-10 code description
Clinically-epidemiologically diagnosed COVID-19
Primary outcomes
1
Description
crp
Timepoint
the first, third, fifth day
Method of measurement
questionnaire
2
Description
wbc
Timepoint
the first, third, fifth day
Method of measurement
questionnaire
3
Description
fever
Timepoint
the first, third, fifth day
Method of measurement
questionnaire
4
Description
tachikardia
Timepoint
the first, third, fifth day
Method of measurement
questionnaire
5
Description
heart rate
Timepoint
the first, third, fifth day
Method of measurement
questionnaire
6
Description
bp
Timepoint
the first, third, fifth day
Method of measurement
questionnaire
7
Description
sa o2
Timepoint
the first, third, fifth day
Method of measurement
questionnaire
8
Description
bs
Timepoint
the first, third, fifth day
Method of measurement
questionnaire
9
Description
plt
Timepoint
the first, third, fifth day
Method of measurement
questionnaire
Secondary outcomes
1
Description
Quality of life score
Timepoint
The first, third and fifth day
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group:atrovastatin 40 mg tablets once a day for 7 days abidi company
Category
Treatment - Drugs
2
Description
Control group:plasibo once a day for 7 days porsina company
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
bualisina hospital of qazvin
Full name of responsible person
abaas allami
Street address
Naderi,bualisina hospital
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
Allami9@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
mahnaz abbasi
Street address
pardis Complex of Qazvin University of Medical Sciences - Shahid Babaei Medical School, second floor, room number 201
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3323 9252
Email
mabasi@qums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
ass llami
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Naderi,bualisina hospital
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
Allami9@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
abass allami
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
naderi ,bualisina hospital
City
qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
Allami9@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
abass allami
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
naderi ,bualisina hospital
City
qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
Allami9@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
If the Vice Chancellor of the University agrees, all data can be shared after identifying individuals
When the data will become available and for how long
From 6 months after printing the results
To whom data/document is available
If the Vice Chancellor of the University agrees, at the request of another researcher to metanize the arrest set, acceptable data will be provided to another researcher.
Under which criteria data/document could be used
If the Vice Chancellor of the University agrees, at the request of another researcher to metanize the arrest set, acceptable data will be provided to another researcher.
From where data/document is obtainable
If the Vice Chancellor of the University agrees, at the request of another researcher to metanize the arrest set, acceptable data will be provided to another researcher.
What processes are involved for a request to access data/document
If the Vice Chancellor of the University agrees, at the request of another researcher to metanize the arrest set, acceptable data will be provided to another researcher.