1. Home
  2. Approved trials
  3. » فارسی

Effect of Atorvastatin to decrease intensity of clinical manifestations in patient with COVID19

Protocol summary

Study aim
Effect of Atorvastatin to decrease intensity of clinical manifestations in patient with COVID19
Design
Clinichal trial with control group and parallel groups, double blind, with using a permuted balanced block randomization method with the size of blocks 4 and 6, phase 3 on 100 patients, Random sequence will be generated by running an online program in sealed envelope website (https://www.sealedenvelope.com/).
Settings and conduct
The aim of this study is evalution of Atorvastatin effect in reducing clinical manifestation of COVID19.Locality of the study is in Amiralmomenin and Khansari hospital of Arak city.In Atorvastatin group, Atorvastatin 40 mg tablet orally (or with gavage in intubated patients) will be added to routine treatment protocol for 10 days from first day and in control group flour tablet that is similar to Atorvastatin will be given to the patients (in addition to routine treatment) for 10 days from first day, too.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with 18 to 75 years old Positive PCR for COVID19 in patients who refer to Amiralmomenin and Khansari hospital of Arak city Having the informed consent Non-inclusion criteria: long time use of Statins Pregnancy and loctation History of sensitivity to Statins Chronic renal failure long time treating with Colchicine, Cyclosporine, Digoxin, Azole antifungal agents, Niacin
Intervention groups
In Atorvastatin group, Atorvastatin 40 mg tablet for 10 days from first day will be added to routine treatment protocol and in control group flour tablet that is similar to Atorvastatin will be given to the patients (in addition to routine treatment).
Main outcome variables
Duration of having fever, Duration of having cough, Atrial oxygen saturation, Duration of intubation, Duration of invasive or non invasive oxygen therapy, Length of hospitalization, Length of ICU stay, Releasing or death

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201028049175N3
Registration date: 2021-01-15, 1399/10/26
Registration timing: prospective

Last update: 2021-01-15, 1399/10/26
Update count: 0
Registration date
2021-01-15, 1399/10/26
Registrant information
Name
Shamim Valibak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.valibak@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Atorvastatin to decrease intensity of clinical manifestations in patient with COVID19
Public title
Effect of Atorvastatin to decrease intensity of clinical manifestations in patient with COVID19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with 18-75 years old Patients with positive PCR test for COVID19 who ara referred to Amiralmomenin and Khansari hospitals of Arak city Patients who have informed consent for entrance into the study.
Exclusion criteria:
Pregnancy and lactation
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into two groups using a permuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of permuted balanced block randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients blindness: Both kinds of tablets(Atorvastatin and flour tablet) are similar in shape and time of use. Nurses blindness: Preparation and appropriation of drugs will be accomplished by the physician.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Basij square
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.ARAKMU.REC.1399.257

Health conditions studied

1

Description of health condition studied
Coronavirus Disease 2019 (COVID19)
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Duration of having fever
Timepoint
Measuement of body temperature daily from first day to releasing day
Method of measurement
Thermometer

2

Description
Duration of having cough
Timepoint
Daily evaluation of having cough from first day to releasing day
Method of measurement
Quastion of patient or his carer

3

Description
Atrial oxygen saturation in hospital
Timepoint
Daily evaluation from first day to releasing day
Method of measurement
Pulse oximeter

4

Description
Length of hospitaliztion
Timepoint
From first day of hospitalization to releasing day
Method of measurement
patient file

5

Description
Length of ICU stay
Timepoint
From first day of hospitalization to releasing day
Method of measurement
patient file

6

Description
Duration of intubation
Timepoint
From first day of hospitalization to releasing day
Method of measurement
patient file

7

Description
Mortality
Timepoint
From first day of hospitalization to releasing day
Method of measurement
patient file

8

Description
Duration of oxygen therapy
Timepoint
From first day of hospitalization to releasing day
Method of measurement
Patient file

Secondary outcomes

1

Description
White blood cell count
Timepoint
From first day of hospitalization to releasing day
Method of measurement
patient file

2

Description
lymphocyte percentage
Timepoint
From first day of hospitalization to releasing day
Method of measurement
patient file

3

Description
Lactate dehydrogenase level
Timepoint
From first day of hospitalization to releasing day
Method of measurement
patient file

4

Description
Creatine phosphokinase level
Timepoint
From first day of hospitalization to releasing day
Method of measurement
patient file

Intervention groups

1

Description
Intervention group: Atorvastatin 40 mg tablet orally (or with gavage in intubated patients) will be added to routine treatment protocol for 10 days from first day of hospitalization.
Category
Treatment - Drugs

2

Description
Control group:Placebo drug (flour tablet) which is similar to Atorvastatin in its shape and size will be given to the patients for 10 days from first day of hospitalization (in addition to routine treatment).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khansari hospital
Full name of responsible person
Masumeh Soofian
Street address
The end of Daneshgah street
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5001
Email
research@arakmu.ac.ir

2

Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Behnam mahmoodieh
Street address
Amiralmomenin hospital street, Basij square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Basij square
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Position
lecturer
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
086-32222003-8
Email
alikamaliir@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masumeh Soofian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Khansari hospital
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5001
Email
dr.sofian@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
shamim valibak
Position
General physician non-faculty
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
086-32222003-8
Email
sh.valibak@yahoo.com

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
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
Loading...