Investigating the Effect of National Protocol for Treatment of Covid-19 Disease on Amino Acids, Carnitines and Acylcarnitine's Profile of Plasma in Hospitalized Patients
Determining the plasma concentrations of amino acids, carnitines and acylcarnitine's in hospitalized patients with covid-19 using Liquid Chromatography, Mass Spectrometry (LC-MSS) method and investigating the relationship of these metabolic factors with side effects in this patients
Design
A prospective, single, unblinded, phase 2-3 clinical trial on 30 patients
Settings and conduct
Place of study: Masih Daneshvari Hospital, How to conduct the study: Blood samples are placed into a liquid chromatography-mass spectrometry system after preparation. By testing the significance of the difference in the average concentrations of amino acids, carnitines and acylcarnitine's of the intervention group and the standard mean concentrations , the effect of the disease on the concentrations of these metabolic factors will be examined
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with a positive PCR test; moderate to severe pulmonary involvement; respiratory rate less than or equal to 30 per minute and the percentage of oxygen saturation less than or equal to 94
Non-inclusion criteria: Patients with mechanical ventilation and psychotic disorders
Intervention groups
From 30 patients, blood samples is collected on Guthrie Whatman 903 paper on the third day of hospitalization
Main outcome variables
Plasma levels of amino acids, carnitines and acylcarnitine's, side effects and clinical outcomes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N35
Registration date:2023-10-18, 1402/07/26
Registration timing:prospective
Last update:2023-10-18, 1402/07/26
Update count:0
Registration date
2023-10-18, 1402/07/26
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-15, 1402/08/24
Expected recruitment end date
2024-11-14, 1403/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of National Protocol for Treatment of Covid-19 Disease on Amino Acids, Carnitines and Acylcarnitine's Profile of Plasma in Hospitalized Patients
Public title
Effect of Coronavirus Treatment Protocol on Metabolic Factors of Plasma
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with positive PCR test
Patients with moderate to severe pulmonary involvement
Patients with respiratory rate less than or equal to 30 breaths per minute
Patients with percentage of saturated oxygen less than or equal to 94
Exclusion criteria:
Patients with mechanical ventilation
Patients with psychotic disorders
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Shahid Beheshti University of Medical Sciences
Street address
3 rd floor, School of Medicine, Evin Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-03-14, 1400/12/23
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.022
Health conditions studied
1
Description of health condition studied
COVID-19 pneumonia
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Plasma concentrations of amino acids, carnitines and acylcarnitine's
Timepoint
On the third day of hospitalization
Method of measurement
Liquid chromatography-Mass spectrometry
Secondary outcomes
1
Description
Adverse drug reaction
Timepoint
At the end of the study
Method of measurement
Medical record
Intervention groups
1
Description
Intervention group: From 30 patients receiving the national protocol for treatment of Covid-19 disease, blood samples is taken on Guthrie Whatman 903 paper on the third day of hospitalization
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farzaneh Dastan
Street address
Masih Daneshvari Hospital, Shahid Bahonar Street (Niyavaran), Darabad, Tehran
City
Tehran
Province
Tehran
Postal code
1956944431
Phone
+98 21 2712 3000
Email
f_dastan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzad Kobarfard
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niayesh Highway, Valieasr St.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0092
Email
kobarfard@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niayesh Highway, Valieasr St.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8887 3704
Email
f_dastan@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzad Kobarfard
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niayesh Highway, Valieasr St.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0092
Email
kobarfard@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sadaf Ehdaeivand
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niayesh Highway, Valieasr St.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
sadafehdaivand1998@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
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
All potential data can be shared after blinding
When the data will become available and for how long
Six months after publishing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and meta-analysis studies
From where data/document is obtainable
Dr. Farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
What processes are involved for a request to access data/document
Official letter to the researchers through Email (fzh.dastan@gmail.com)