Comparison of the complementary effect of L-carnitine and placebo on the clinical outcomes of patients with COVID-19 (2019-nCov) admitted to the intensive care unit
Evaluation of the complementary effect of L-carnitine on the clinical consequences of patients with COVID-19 (2019-nCov) hospitalized in the intensive care unit
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 42 patients. Randomization method will be using randomized blocks produced by the online site (www.sealedenvelope.com).
Settings and conduct
The place of present project is in the intensive care unit of Imam Reza Hospital in Mashhad. In this study, people over the age of 18 with COVID-19 are randomly divided into two groups receiving medication or placebo for 7 days. The study is a double-blind study in which the patient and the intervene are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Acute Respiratory Infection from COVID-19, Age 18-65 years old, Tendency to participate in study
Non inclusion criteria: Covid-19 with mold diarrhea, history of L-carnitine allergy, use of anticonvulsant drugs, hemodialysis
Intervention groups
Intervention group: 3000 mg L-carnitine supplement, Control group: Pasteurized drinking water that is randomly packaged and covered (blinding) is gavaged to patients for 7 days
Main outcome variables
Mortality within the intensive care unit; the number of days of ventilator dependence; sepsis; respiratory distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151108024938N3
Registration date:2023-08-21, 1402/05/30
Registration timing:retrospective
Last update:2023-08-21, 1402/05/30
Update count:0
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
Alireza Sedaghat
Name of organization / entity
Mashhad university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 3701
Email address
sedaghatar@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
2022-03-21, 1401/01/01
Actual recruitment end date
2023-03-21, 1402/01/01
Trial completion date
2023-07-23, 1402/05/01
Scientific title
Comparison of the complementary effect of L-carnitine and placebo on the clinical outcomes of patients with COVID-19 (2019-nCov) admitted to the intensive care unit
Public title
Effect of L-carnitine on COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients COVID-19, admitted to intensive care unit
Age 18-65 years old
Satisfaction to participate in the study
Exclusion criteria:
Covid-19 with mold diarrhea
History of L-carnitine allergy
Use of anticonvulsant drugs
Hemodialysis
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
42
Actual sample size reached:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization , block method.
Randomization was performed by random block method using statistical software. In order to apply concealment in the randomization process, unique codes will be used on drug boxes, the desired code is also generated by the online site.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, medical staff, and interventionist are all aware of the type of study and the contents of the medication and placebo packages, and only the fact that the codes of the medications remain hidden from these individuals.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Faculty of Medicine, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2020-04-11, 1399/01/23
Ethics committee reference number
IR.MUMS.REC.1399.026
Health conditions studied
1
Description of health condition studied
Acute respiratory infection caused by coronavirus
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified
2
Description of health condition studied
Acute respiratory infection caused by coronavirus
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Ventilator dependence
Timepoint
Before and 7 days after intervention
Method of measurement
Using ABG and the opinion of an anesthesiologist
2
Description
C-reactive protein (CRP)
Timepoint
Before and 7 days after intervention
Method of measurement
Quantitative method, by ELISA method
Secondary outcomes
1
Description
Mortality within the intensive care unit
Timepoint
Before intervention and 7 days after intervention
Method of measurement
Observe the occurrence
2
Description
The ratio of neutrophils to lymphocytes
Timepoint
Before intervention and 7 days after intervention
Method of measurement
Using a complete blood test
3
Description
Blood levels of lactate dehydrogenase
Timepoint
Before intervention and 7 days after intervention
Method of measurement
Enzymatic method
4
Description
The incidence of sepsis
Timepoint
Before intervention and 7 days after intervention
Method of measurement
Based on the diagnosis of the treating physician and SIRS criteria
5
Description
The incidence of respiratory distress
Timepoint
Before intervention and 7 days after intervention
Method of measurement
Based on the diagnosis of the treating physician and SIRS criteria
Intervention groups
1
Description
Intervention group: Receiver of 3000 mg of L-carnitine daily for 7 days by gavage from Kasra-zist takhmir bonyan company
Category
Treatment - Drugs
2
Description
Control group: Receiving 10 cc pasteurized drinking water daily for 7 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospitals
Full name of responsible person
Alireza sedaghat
Street address
Emam reza hospital; Daneshgah avenue
City
Mashhhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3802 3701
Fax
+98 51 3871 3638
Email
SedaghatAr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza sedaghat
Street address
Mashhad University of Medical Sciences; Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
sedaghatar@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Mostafa Arabi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Mashhad University of Medical Sciences; Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
913881394
Phone
+98 51 3882 8574
Email
arabim941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Mostafa Arabi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Mashhad University of Medical Sciences; Azadi square
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3882 7033
Email
arabim941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Mostafa Arabi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Mashhad University of Medical Sciences; Azadi square
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3882 8574
Email
arabim941@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