Evaluation the efficacy and safety of Atorvastatin as adjutant therapy in hospitalized patients with COVID-19 infection
Design
The study is a non-randomized, single-blind clinical trial
Settings and conduct
Clinical trials will be conducted at the Bu Ali Hospital affiliated to Islamic azad university Tehran Medical Sciences on hospitalized COVID-19 patients. Patients are treated in intervention and control groups. The study will be performed at the beginning of patient hospitalization. At the end of the study results will be presented to analyzer in two blinded groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Older than 18 years old, Hospitalized with COVID-19 infection and signed the informed consent
Exclusion criteria: Pregnancy, lactation, history of allergy to atorvastatin. Presence of other contraindications, Enrollment in another clinical study
Intervention groups
Control group: only standard drug therapy for coronavirus recommended by local national guideline will be received.
intervention group: This group adjunct to standard treatment will receive Atorvastatin 20 mg orally once daily
Main outcome variables
Clinical response, Laboratory response. Rate of adverse drug reactions, Rate of complications secondary to COVID-19 infection, Duration of hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200413047062N1
Registration date:2020-05-04, 1399/02/15
Registration timing:registered_while_recruiting
Last update:2020-05-04, 1399/02/15
Update count:0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Hamid Reza Moezi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3334 8040
Email address
hmoezi@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-13, 1399/01/25
Expected recruitment end date
2020-05-14, 1399/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of Atorvastatin in clinical improvement, prognosis and hospitalization course in patients with COVID-19 infection
Public title
Effect of Atorvastatin in treatment of COVID-19 infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients age over 18 years
Hospitalized with diagnosis of COVID-19 infection
Exclusion criteria:
Pregnancy
Lactation
History of hypersensitivity reaction to atorvastatin,
Liver dysfunction (Liver enzymes > 3 ULN or bilirubin >2 ULN or history of liver failure)
Renal failure (eGFR < 30ml/min),
History of major side effects with statins (such as liver toxicity, rhabdomyolysis)
Patients are receiving other drugs which have major interaction (such as Gemfibrozil, cyclosporine, amiodarone, itraconazole, variconazole, clarithromycin)
LDL Level below than 40 mg/dl
Involvement in another clinical study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, after receiving informed consent from of both control and intervention groups, all oral medications of both group are administered in boxes with different codes, as a result, the patient is unaware that he or she has been received atorvastatin in addition to other medications and they kept blind. also, the researcher who will analyze the data will be blind using codes for different groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Of Pharmaceutical Sciences Branch
Street address
Yakhchal Avenue، Qolhak، Dotor Shariati Avenue
City
Tehran
Province
Tehran
Postal code
193956466
Approval date
2020-04-12, 1399/01/24
Ethics committee reference number
IR.IAU.PS.REC.1399.002
Health conditions studied
1
Description of health condition studied
COVID-19 infection
ICD-10 code
U07.1
ICD-10 code description
COVID-19 has been confirmed by laboratory testing
Primary outcomes
1
Description
Time to clinical improvement (TTIC)
Timepoint
Daily
Method of measurement
Based on clinical findings such as fever, respiratory rate, percentage of oxygen saturation, cough
2
Description
Duration of hospitalization
Timepoint
End of the treatment
Method of measurement
Patient's record
3
Description
Adverse effects
Timepoint
Daily
Method of measurement
Interview and patient's record
4
Description
Clinical outcome (cure or death)
Timepoint
End of the treatment
Method of measurement
Patient's record
Secondary outcomes
1
Description
need for ICU admission
Timepoint
Daily
Method of measurement
Patient's record
2
Description
Need for Mechanical ventilation
Timepoint
Daily
Method of measurement
Interview and patient's record
3
Description
Change in radiologic findings
Timepoint
End of the treatment
Method of measurement
Patient's record
4
Description
The change in inflammatory markers
Timepoint
daily
Method of measurement
Patient's record
Intervention groups
1
Description
Intervention group: Concomitant with the national corona treatment recommendation + Atorvastatin 20 mg daily for full course of therapy
Category
Treatment - Drugs
2
Description
Control group: Only national corona treatment recommendation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali hospital
Full name of responsible person
Hamidreza Moezi
Street address
Bu Ali hospital, Imam Hossein sq. Damavand Ave. Tehran
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3334 8036
Email
Hmoezi@iautmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Shariati Avenue, Yakhchal Street,Tehran
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2264 0599
Email
hashemian.f@iaups.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Hamidreza Moezi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Islamic Azad University, Tehran Medical Branch, Shariati St. Khaghani St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
Hmoezi@iautmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Keyhan Mohammadi
Position
Resident of Clinical pharmacy (BCPS)
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4709
Email
Keyhanmohammadi72@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maysa Ghayyem
Position
Internal Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Islamic Azad University, Tehran Medical Branch, Shariati St. Khaghani St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
Maysa.qayyem@gmail.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
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
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
Title and more details about the data/document
Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript
When the data will become available and for how long
up to One year after finishing the study, data will be published and will be available in databases
To whom data/document is available
After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes
Under which criteria data/document could be used
Other researchers are permitted to included the results in their reviews and meta-analysis
From where data/document is obtainable
contact with Dr hamidreza moezi at school of medicine, Islamic Azad University, Tehran Medical Branch
What processes are involved for a request to access data/document
After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks