Determining the effect of melatonin with N-acetylcysteine in reducing liver damage caused by Ramdesivir injection in AJA staff with Covid 19 in Tehran hospitals in 2022
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 4 on 80 patients, which used a random number table for randomization.
Settings and conduct
The subjects will be selected from the AJA staff with Covid 19 disease in Tehran hospitals in 2022 who meet the inclusion criteria to reach the desired sample size. Then Patients are divided into two random groups that are matched in terms of age and sex. The intervention group received 6 mg of melatonin at bedtime and 600 mg of acetylcysteine during hospitalization, and the control group received a placebo at the same time with a similar appearance. All patients will be screened for AST and ALT at the time of admission serially until discharge, as well as underlying variables including age, sex and disease severity . It is noteworthy that during this period, patients and researchers will be unaware of the type of drug prescribed.
Participants/Inclusion and exclusion criteria
Hospitalization indication of Covid 19 patient
Indication for Remdesivir injection
Patient satisfaction to participate in this research project
Patients over 18 years old
Presence of underlying liver disease in the patient
Inability to receive oral durg
Intervention groups
The intervention group received 6 mg of melatonin at bedtime and 600 mg of n-acetylcysteine during hospitalization, and the control group received a placebo with the same appearance at the same time.
Main outcome variables
The effect of melatonin and N-acetylcysteine in reducing liver damage caused by remedisovir injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210926052586N2
Registration date:2022-02-26, 1400/12/07
Registration timing:prospective
Last update:2022-02-26, 1400/12/07
Update count:0
Registration date
2022-02-26, 1400/12/07
Registrant information
Name
Seyedmohammad Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 6660
Email address
smkarimi.md@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-27, 1400/12/08
Expected recruitment end date
2022-04-28, 1401/02/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin with N-acetylcysteine in reducing liver injury caused by Remdesivir injection in Covid 19 patients
Public title
Evaluation of the effect of melatonin with N-acetylcysteine in reducing liver injury caused by Remdesivir injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization indication of Covid 19 patient
Indication for Remdesivir injection
Patient satisfaction to participate in this research project
Patients over 18 years old
Exclusion criteria:
Presence of underlying liver disease in the patient
Inability to receive oral drug
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The table of random numbers is prepared and by placing a hand on a number randomly and moving the hand in one of the predetermined directions, each person is given a number. People who have even numbers in will be in intervention group A and individual numbers will be in the group Intervention B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researchers remain unaware of how the drug is allocated during the study. The patient is informed that there are two types of drugs in a study and will take one of the two drugs at random. Both drugs are in the same package and have are no difference.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of AJA University of Medical Sciences
Street address
AJA University of Medical Sciences , Shahid Etemadzadeh St. , West Fatemi St.
City
تهران
Province
Tehran
Postal code
1411718541
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
IR.AJAUMS.REC.1400.306
Health conditions studied
1
Description of health condition studied
liver injury
ICD-10 code
S36.119A
ICD-10 code description
Unspecified injury of liver, initial encounter
Primary outcomes
1
Description
The effect of melatonin with N-acetylcysteine in reducing liver injury caused by Remdesivir injection
Timepoint
From the time of hospitalization serially until discharge
Method of measurement
Liver enzymes for aspartate aminotransferase , alanine aminotransferase and Alkaline phosphatase from blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During hospitalization, 6 mg of melatonin before bed and 600 mg of N acetylcysteine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Seyedmohammad
Street address
Besat Hospital , Hijrat Street , Takhti Three Ways , Basij Highway
City
Tehran
Province
Tehran
Postal code
1781997511
Phone
+98 21 3995 5555
Email
host600@isiran_net.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zashk
Street address
AJA University of Medical Sciences, Etemadzadeh Ave. , West Fatemi St.
City
Tehran
Province
Tehran
Postal code
14117118541
Phone
+98 21 8609 6350
Email
dr.yousefi.md@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Seyedmohammad Karimi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Pabarja St , Sheidaei Ave , Darrous
City
Tehran
Province
Tehran
Postal code
1979999999
Phone
+98 21 8609 6350
Fax
Email
smkarimi.md@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohammad Darivishi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Infectious Disease 1 Unit , Besat Hospital , Hijrat Street , Takhti Three Ways , Basij Highway
City
Tehran
Province
Tehran
Postal code
1979999999
Phone
+98 21 8609 6350
Fax
Email
darvishi1349@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyedmohammad Karimi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Pabarja St , Sheidaei Ave , Darrous
City
Tehran
Province
Tehran
Postal code
1979999999
Phone
+98 21 8609 6350
Fax
Email
smkarimi.md@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