The potential effect of parenteral L-carnitine in hospitalized patients with moderate to severe COVID-19
Design
This double blind clinical trial has two intervention and control groups, which are a total of 100 patients and are randomly divided into two groups. The groups are parallel.
Settings and conduct
Hospitalized patients with COVID-19 will be divided into 2 groups by permuted block randomization with envelopes. The study is double-blind in which the data collector and participants will be blind. Patients will be given parenteral L-carnitine or its similar placebo at a dose of 100mcg/Kg until hospitalization or up to 14 days.
Participants/Inclusion and exclusion criteria
- Adults aged 18 years or older
- Positive PCR test for COVID-19 or evidence against the disease
- Patients with moderate to severe disease
- Signs and symptoms compatible with COVID-19 disease according to the Iranian Ministry of Health protocol
- Prior to the fifth day of symptoms onset
Intervention groups
Administering 100 mcL/kg (20 mg/Kg) of parenteral L-Carnitine in addition to the standard care therapy Until the time of hospitalization or up to 14 days
Main outcome variables
Disease severity
Length of hospitalization
mortality
Time to improve clinical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170609034406N10
Registration date:2023-01-17, 1401/10/27
Registration timing:prospective
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
Afshin Gharekhani
Name of organization / entity
Faculty of Pharmacy/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1315
Email address
gharekhania@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The potential effect of parenteral L-carnitine on hospitalized patients with moderate to severe COVID-19
Public title
The effect of parenteral L- carnitine on patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
adults aged 18 years or older
Positive PCR test for COVID-19
Patients with moderate to severe disease
Signs and Symptoms compatible with COVID-19 disease according to the Iranian Ministry of Health protocol
Prior to the fifth day of symptoms onset
Exclusion criteria:
Pregnancy
Lactation
HIV Infection
History of taking L-carnitine supplement in the recent Month
known immunosuppression condition or any active malignancy
Patients with hypothyroidism or hyperthyroidism
patients with regular aerobic training (more than 3 times a week with further than 2 hours each time)
History of allergy to L-carnitine or its analogues
History of or an increased risk for seizure
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
2
serum
Randomization (investigator's opinion)
Randomized
Randomization description
This study will use the permuted block randomization method to assign patients into control and treatment groups. This study will have 25 blocks containing 4 patients allocated to treatment and the control group. Random numbers in this study will be generated using excel software to determine coalitions, and study groups randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted in a double-blind manner, none of the prescribers and patients and data collectors will know which of the patients received L-carnitine or placebo, and only through the numbers provided by The system was given to patients, it will be diagnosed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Vice-Chancellor, Third floor, No. 2, Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5766414766
Approval date
2022-11-19, 1401/08/28
Ethics committee reference number
IR.TBZMED.REC.1401.749
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
The length of hospitalization
Timepoint
At the end of study
Method of measurement
Comparing the number of hospitalization days between the intervention group and control group
2
Description
Disease severity
Timepoint
Daily
Method of measurement
Disease Severity Checklist in NIH Guidelines
3
Description
Mortality
Timepoint
End of study
Method of measurement
Patient file
4
Description
Time to improve clinical symptoms
Timepoint
Daily
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Serum Ferritin level
Timepoint
At the beginning and end of the study
Method of measurement
Ferritin kit
2
Description
Serum LDH (Lactate Dehydrogenase) level
Timepoint
At the beginning and end of the study
Method of measurement
Alkaline phosphatase Assay Kit (DGKC Kit)
3
Description
Serum D_dimer level
Timepoint
At the beginning and end of the study
Method of measurement
D_dimer ELISA kit
4
Description
serum C_ reactive protein (CRP) level
Timepoint
At the beginning and end of the study
Method of measurement
CRP ELISA Kit
5
Description
Oxygen saturation
Timepoint
Daily
Method of measurement
oxymeter
6
Description
Require for mechanical ventilation
Timepoint
daily
Method of measurement
observation
7
Description
L-carnitine serum level
Timepoint
baseline and end of the study
Method of measurement
ELISA kit
Intervention groups
1
Description
Intervention group (L-carnitine + standard care): 50 patients with COVID-19 diagnosis will be included in the study according to the inclusion and exclusion criteria, and will receive 100mcL/kg (20 mg/kg) parenteral L-carnitine once daily until hospitalization or up to 14 days along with the standard care recommended by the Iranian Ministry of Health protocol.
Category
Treatment - Drugs
2
Description
Control group: (placebo + standard care): 50 patients with COVID-19 will be included in the study based on the inclusion and exclusion criteria, and will receive the equivalent volume of L-carnitine as100mcL/kg from normal saline serum once daily until hospitalization or a maximum of 14 days along with the standard care recommended by the Iranian Ministry of Health protocol
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Haspital
Full name of responsible person
Afshin Gharekhani
Street address
Sina Educational and Medical Center, between Shahid Montazeri and Hafez intersections, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3549 8342
Email
anqarekhani@yahoo.com
2
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Afshin Gharekhani
Street address
Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3337 3901
Email
gharekhania@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Afshin Gharekhani
Street address
No 2 central building, Tabriz University of Medical sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5766414766
Phone
+98 41 3337 2250
Email
gharekhania@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 2250
Email
gharekhania@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences, Daneshgah Street , Tabriz , Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5351
Email
gharekhania@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Naeimzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy , Tabriz University of Medical Science , Daneshgah Street , Tabriz , Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3333 7244
Email
f.naeimzadeh372@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
Yes - There is 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
Title and more details about the data/document
Results and data on primary and secondary outcomes will be shared.
When the data will become available and for how long
3 years after publication
To whom data/document is available
The results and data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
For meta-analysis only
From where data/document is obtainable
by email
What processes are involved for a request to access data/document