Protocol summary

Study aim
Effect of atorvastatin on mortality rate and symptom improvement in hospitalized patients with COVID-19
Design
A randomized, clinical trial with a parallel group design of 80 patients in each group (totally 160 patients), and followed till they are hospitalized. Randomization will be done with computer.
Settings and conduct
In this study the effect of atorvastatin on mortality rate and symptom improvement in hospitalized patients with COVID-19 are going to be evaluated. COVID-19 infected people who are inpatients in Emam Hassan Hospital, Bojnoord are randomized into control or intervention group. Control group: Hydroxychloroquine and Kaletra treatment according to the national guideline for the treatment of COVID-19 Intervention group: Hydroxychloroquine and Kaletra treatment according to the national guideline for the treatment of COVID-19 and Atorvastatin, 1 tablet, 20 mg, daily, during hospitalization
Participants/Inclusion and exclusion criteria
COVID-19 infected patients who are inpatients in the hospital and are treated with Kaletra and Hydroxychloroquine. these patients have no underlying diseases and have no need to I.C.U when are registered in this study.
Intervention groups
Control group: Hydroxychloroquine and Kaletra treatment according to the national guideline for the treatment of COVID-19, during hospitalization Intervention group: Hydroxychloroquine and Kaletra treatment according to the national guideline for the treatment of COVID-19 and Atorvastatin, 1 tablet, 20 mg, daily, during hospitalization
Main outcome variables
Duration of stay at hospital; mortality rate; indication for Intubation; duration of intubation; duration of improvement in clinical sign and symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190831044653N5
Registration date: 2020-08-24, 1399/06/03
Registration timing: registered_while_recruiting

Last update: 2020-08-24, 1399/06/03
Update count: 0
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Maryam Rameshrad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7182
Email address
rameshrm2@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-08-20, 1399/05/30
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of atorvastatin on mortality rate and symptom improvement in hospitalized patients with COVID-19
Public title
َThe effect of Atorvastatin therapy in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 infected people who are inpatient in the hospital
Exclusion criteria:
type 1 diabetes ketoacidosis Uncompensated heart failure sever renal failure GFR<30ml/min metabolic acidosis structural respiratory dysfunction Indications for Intubation at the registering time to the hospital
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization will be used. At first, the block size is considered 4. Then, the possible ways to equally assign participants to a block will be written for 160 subjects. (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)-…- BAAB(n)). After that, numbers between 1-n will be chosen randomly from the table of random numbers which shows the ordinary of the blocks for participating in the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
Shahryar
City
Bojnurd
Province
North Khorasan
Postal code
9417694786
Approval date
2020-05-04, 1399/02/15
Ethics committee reference number
IR.NKUMS.REC.1399.035

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
hospitalization
Timepoint
end of study
Method of measurement
Patient file in the hospital

Secondary outcomes

1

Description
mortality rate
Timepoint
end of study
Method of measurement
Patient file in the hospital

2

Description
intubation indication
Timepoint
end of study
Method of measurement
Patient file in the hospital

3

Description
duration of intubation
Timepoint
end of study
Method of measurement
Patient file in the hospital

4

Description
duration of sign and symptoms (fever, cough ,...)
Timepoint
daily
Method of measurement
Patient file in the hospital and questionnaire

Intervention groups

1

Description
Intervention group: Hydroxychloroquine and Kaletra treatment according to the national guideline for the treatment of COVID-19 and Atorvastatin, 1 tablet, 20 mg, daily, during hospitalization
Category
Treatment - Drugs

2

Description
Control group: Hydroxychloroquine and Kaletra treatment according to the national guideline for the treatment of COVID-19, during hospitalization
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emem Hasan hospital
Full name of responsible person
Dr. Majid Ghafoori
Street address
Shahriar
City
Bojnurd
Province
North Khorasan
Postal code
9417694786
Phone
+98 58 3229 7182
Fax
+98 58 3229 7182
Email
ghafourim841@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
dr. seyed Kaveh Hojat
Street address
Shahriar
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Phone
+98 58 3229 7182
Email
S.Kavehhojjat1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Majid Ghafoori
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Shahriar street,
City
Bojnurd
Province
North Khorasan
Postal code
9417694786
Phone
+98 58 3229 7182
Fax
+98 58 3229 7182
Email
ghafourim841@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Majid Ghafoori
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Shahriar street,
City
Bojnurd
Province
North Khorasan
Postal code
9417694786
Phone
+98 58 3229 7182
Fax
+98 58 3229 7182
Email
ghafourim841@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Maryam Rameshrad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahriar street,
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Phone
+98 58 3229 7182
Fax
+98 58 3229 7182
Email
rameshrm2@mums.ac.ir

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
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