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Evaluation of the Effects of L-carnitine Supplementation on Clinical Outcomes in Hospitalized Patients with COVID-19

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History
# Registration date Revision Id
2 2021-01-09, 1399/10/20 166719
1 2020-11-19, 1399/08/29 159352
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  • Protocol summary

    This clinical trial has two intervention and control groups, which are a total of 96 patients and are randomly divided into two groups. This study is a phase 3 clinical trial and is parallel and not-blinded.
    This clinical trial has two intervention and control groups, which are a total of 64 patients and are randomly divided into two groups. This study is a phase 3 clinical trial and is parallel and not-blinded.
    این کارازمایی بالینی دارای دو گروه مداخله و کنترل میباشد که در مجموع تعداد بیماران 96 نفر میباشند و به صورت تصادفی در دو گروه تقسیم بندی میشوند. این مطالعه فاز 3 کلینیکال ترایال میباشد و به صورت موازی و کور نشده است.
    این کارازمایی بالینی دارای دو گروه مداخله و کنترل میباشد که در مجموع تعداد بیماران 64 نفر میباشند و به صورت تصادفی در دو گروه تقسیم بندی میشوند. این مطالعه فاز 3 کلینیکال ترایال میباشد و به صورت موازی و کور نشده است.
    Evaluation of clinical consequences of L-carnitine such as inflammatory factors like CRP, ESR and other factors such as ALT, AST, LDH, CPK, WBC, PT, INR , GSH , SOD and other
    Evaluation of clinical consequences of L-carnitine such as inflammatory factors like CRP, ESR and other factors such as ALT, AST, LDH, CPK, WBC, PT, INR and other
    بررسی پیامدهای بالینی ال کارنیتین نظیر فاکتورهای التهابی مثل CRP,ESR و فاکتورهای دیگر نظیر ALT, AST, LDH, CPK, WBC, PT, INR , GSH , SOD , ...
    بررسی پیامدهای بالینی ال کارنیتین نظیر فاکتورهای التهابی مثل CRP,ESR و فاکتورهای دیگر نظیر ALT, AST, LDH, CPK, WBC, PT, INR , ...

  • General information

    96
    64
    2020-11-20, 1399/08/30
    2021-02-19, 1399/12/01
    2021-03-19, 1399/12/29
    2021-06-21, 1400/03/31
    empty
    Reduce the number of statistical samples according to the circumstances؛ Eliminate numbers of primary outcome variables
    empty
    کاهش تعداد نمونه آماری بنابر شرایط پیش آمده، حذف تعدادی از متغیر های پیامد اولیه
    Pregnancy
    Breastfeeding
    Severe Cardiovascular Disease
    HIV Infection
    History of Taking L-carnitine Supplementation in the Past Month
    Requires Care in the ICU
    Taking Anti-Inflammatory and Anti-Oxidative Stress Drugs out of the Medication Regimen
    Patients with High and Critical Disease Severity
    Patient Dissatisfaction to Enter the Plan
    Pregnancy
    Breastfeeding
    Severe Cardiovascular Disease
    HIV Infection
    History of Taking L-carnitine Supplementation in the Past Month
    Requires Care in the ICU
    Taking Anti-Inflammatory Drugs out of the Medication Regimen
    Patients with High and Critical Disease Severity
    Patient Dissatisfaction to Enter the Plan
    بارداری
    شیردهی
    بیماری های قلبی_عروقی شدید
    عفونت HIV
    سابقه مصرف مکمل ال کارنیتین در یک ماه گذشته
    نیاز به مراقبت در ICU
    مصرف داروهای ضد التهاب و ضد استرس اکسیداتیو خارج رژیم دارویی
    بیماران با شدت بیماری بالا و بحرانی
    عدم رضایت بیمار جهت ورود به طرح
    بارداری
    شیردهی
    بیماری های قلبی_عروقی شدید
    عفونت HIV
    سابقه مصرف مکمل ال کارنیتین در یک ماه گذشته
    نیاز به مراقبت در ICU
    مصرف داروهای ضد التهاب خارج رژیم دارویی
    بیماران با شدت بیماری بالا و بحرانی
    عدم رضایت بیمار جهت ورود به طرح

  • Primary outcomes

    #1
    Glutathione (GSH)
    Red Cell Distribution Width (RDW)
    گلوتاتیون
    میزان پراکندگی گلبول های قرمز
    GSH Kit
    Blood test
    کیت گلوتاتیون
    ازمایش خون
    #2
    Superoxide Dismutase (SOD)
    empty
    سوپر اکسید دسموتاز
    empty
    Beginning and End of the Intervention
    empty
    ابتدا و انتهای مداخله
    empty
    SOD Kit
    empty
    کیت SOD
    empty
    #3
    Ferritin
    empty
    فریتین
    empty
    Beginning and End of the Intervention
    empty
    ابتدا و انتهای مداخله
    empty
    Blood test
    empty
    ازمایش خون
    empty
    #4
    Red Cell Distribution Width (RDW)
    empty
    میزان پراکندگی گلبول های قرمز
    empty
    Beginning and End of the Intervention
    empty
    ابتدا و انتهای مداخله
    empty
    Blood test
    empty
    ازمایش خون
    empty

  • Recruitment centers

    #1
    Name of recruitment center - English: Beheshti Hospital
    Name of recruitment center - Persian: بیمارستان بهشتی
    Full name of responsible person - English: Rasool Haddadi
    Full name of responsible person - Persian: رسول حدادی
    Street address - English: Shahid Beheshti Hospital, Ghaem Square, at the beginning of Eram Blvd
    Street address - Persian: میدان قائم ، ابتدای بلوار ارم ، بیمارستان شهید بهشتی
    City - English: Hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 3371-5-65179
    Phone: +98 81 3838 0283
    Fax:
    Email: Shahidbeheshti@umsha.ac.ir
    Web page address: http://beheshti.umsha.ac.ir/
    Name of recruitment center - English: Beheshti Hospital
    Name of recruitment center - Persian: بیمارستان بهشتی
    Full name of responsible person - English: Dr Saman Talebi
    Full name of responsible person - Persian: دکتر سامان طالبی
    Street address - English: Shahid Beheshti Hospital, Ghaem Square, at the beginning of Eram Blvd
    Street address - Persian: میدان قائم ، ابتدای بلوار ارم ، بیمارستان شهید بهشتی
    City - English: Hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 3371-5-65179
    Phone: +98 81 3838 0283
    Fax:
    Email: Shahidbeheshti@umsha.ac.ir
    Web page address: http://beheshti.umsha.ac.ir/

Protocol summary

Study aim
Determining the Effectiveness of L-carnitine Supplementation on Clinical Outcomes in Hospitalized COVID-19 Patients
Design
This clinical trial has two intervention and control groups, which are a total of 64 patients and are randomly divided into two groups. This study is a phase 3 clinical trial and is parallel and not-blinded.
Settings and conduct
This study is a clinical trial conducted in Shahid Beheshti Hospital in Hamadan at 2020. Patients who are admitted according to the inclusion criteria in this study are randomly divided to the intervention or control group. The control group will receive only routine medications and the intervention group will receive L-carnitine supplements in addition to these medications.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 18 to 60 years؛ Positive PCR test؛ Hospitalization؛ Presence of Symptoms According to the Instructions of the Ministry of Health؛ Mild to moderate disease Exclusion Criteria: Pregnancy؛ Lactation؛ Severe Cardiovascular Disease؛ HIV Infection؛ History of Taking L-carnitine Supplement in the Past Month
Intervention groups
Patients in both intervention and control groups are routinely treated for COVID-19 according to the protocol of the Food and Drug Administration, but in addition to these routine drugs, the intervention group will receive 3 grams of L-carnitine supplement daily for 5 days.
Main outcome variables
Evaluation of clinical consequences of L-carnitine such as inflammatory factors like CRP, ESR and other factors such as ALT, AST, LDH, CPK, WBC, PT, INR and other

General information

Reason for update
Reduce the number of statistical samples according to the circumstances؛ Eliminate numbers of primary outcome variables
Acronym
IRCT registration information
IRCT registration number: IRCT20200921048794N1
Registration date: 2020-11-19, 1399/08/29
Registration timing: prospective

Last update: 2021-01-09, 1399/10/20
Update count: 1
Registration date
2020-11-19, 1399/08/29
Registrant information
Name
Mehran Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4627 4360
Email address
m.ghasemy@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effects of L-carnitine Supplementation on Clinical Outcomes in Hospitalized Patients with COVID-19
Public title
Evaluation of the Effects of L-carnitine Supplementation on Patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years Positive PCR Test Hospitalization Existence of Corona Virus Symptoms According to the Instructions of the Ministry of Health Mild to Moderate Disease Severity
Exclusion criteria:
Pregnancy Breastfeeding Severe Cardiovascular Disease HIV Infection History of Taking L-carnitine Supplementation in the Past Month Requires Care in the ICU Taking Anti-Inflammatory Drugs out of the Medication Regimen Patients with High and Critical Disease Severity Patient Dissatisfaction to Enter the Plan
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
We put 2 sheets A and two sheets B in an envelope and each time we remove one of the sheets, we place the patient in the control or intervention group. The removed sheet will not be returned to the envelope until the all of sheets in the envelope be finished. After randomly pulling out all four sheets, all sheets are returned to the envelope and the above procedure will be continued for the next four patients until the desired sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Mahdieh Street, in front of People's Park
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2020-10-24, 1399/08/03
Ethics committee reference number
IR.UMSHA.REC.1399.650

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
C-Reactive Protein (CRP)
Timepoint
At the Beginning of Intervention (the Zero day) and the End of Intervention (Fifth day )
Method of measurement
Blood test

2

Description
Erythrocyte Sedimentation Rate (ESR)
Timepoint
Beginning and End of the Intervention
Method of measurement
Blood test

3

Description
O2 Saturation
Timepoint
Beginning and End of the Intervention
Method of measurement
Pulse Oximeter

4

Description
Complete Blood Count (CBC)
Timepoint
Beginning and End of the Intervention
Method of measurement
Blood test

5

Description
White Blood Cell (WBC)
Timepoint
Beginning and End of the Intervention
Method of measurement
Blood test

6

Description
Alanine Aminotransferase (ALT)
Timepoint
Beginning and End of the Intervention
Method of measurement
Blood test

7

Description
Lactate Dehydrogenase (LDH)
Timepoint
Beginning and End of the Intervention
Method of measurement
Blood test

8

Description
Creatine Phosphokinase (CPK)
Timepoint
Beginning and End of the Intervention
Method of measurement
Blood test

9

Description
Creatinine
Timepoint
Beginning and End of the Intervention
Method of measurement
Blood test

10

Description
Urea
Timepoint
Beginning and End of the Intervention
Method of measurement
Blood test

11

Description
Prothrombin Time (PT)
Timepoint
Beginning and End of the Intervention
Method of measurement
Blood test

12

Description
Red Cell Distribution Width (RDW)
Timepoint
Beginning and End of the Intervention
Method of measurement
Blood test

Secondary outcomes

1

Description
Fever
Timepoint
Beginning and End of the Intervention
Method of measurement
Patient File

2

Description
Cough
Timepoint
Beginning and End of the Intervention
Method of measurement
Questionnaire

3

Description
Mortality Rate
Timepoint
During the intervention
Method of measurement
Death of the Patient

4

Description
Duration of Hospitalization
Timepoint
Beginning and End of the Intervention
Method of measurement
Days

5

Description
ICU Referral
Timepoint
During the Intervention
Method of measurement
Observational

6

Description
Requires Ventilation
Timepoint
During the Intervention
Method of measurement
Observational

Intervention groups

1

Description
Control group: This hospitalized group receives only their routine medication regimen which includes Dexamethasone, Interferon beta and Favipiravir.
Category
Treatment - Drugs

2

Description
Intervention group: The intervention group in addition to their usual treatment regimen received 1000 mg L-carnitine tablets of Karen Company for 5 days and 3 g daily, three oral tablets daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Dr Saman Talebi
Street address
Shahid Beheshti Hospital, Ghaem Square, at the beginning of Eram Blvd
City
Hamedan
Province
Hamadan
Postal code
3371-5-65179
Phone
+98 81 3838 0283
Email
Shahidbeheshti@umsha.ac.ir
Web page address
http://beheshti.umsha.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
20
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
Hamedan University of Medical Sciences
Full name of responsible person
Mehran Ghasemi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1593
Email
mehranghasemy76@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Rasool Haddadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Faculty of Pharmacy, Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1593
Email
haddadi.rasool@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehran Ghasemi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1593
Email
mehranghasemy76@gmail.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
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