Evaluation of the effect of Donepezil Hydrochloride on memory impairment in patients recovered from Covid-19 with hospitalization history in comparison with the control group
Evaluation of the effect of Donepezil Hydrochloride on memory impairment in patients recovered from Covid19 with a history of hospitalization; Evaluation of memory impairment before and after drug administration in the case group (drug recipient); Evaluation of memory impairment in the control group simultaneously with the case group; Comparison of case group with control group in terms of improvement of memory impairment before, one, three and six months after drug administration
Design
Randomized single blind clinical trial with control group with parallel groups, phase 3 on at least 70 patient using a table of random numbers in Excel
Settings and conduct
This study is performed on Covid19 recovered patients with a history of hospitalization about one month ago who have referred to the Family Hospital`s clinic and have memory impairment. This study is single blinded (the data analyzer (statistic counselor) is blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients between 20-50 years old that recovered from Covid-19, with a history of hospitalization ; suffer from memory impairment after recovery from Covid19 Exclusion criteria: History of previous cognitive problems, stroke, head trauma or cerebral hemorrhage, physical and psychiatric disease; Use of drugs with effect on cognitive function ;Consumption of drugs, stimulants and alcohol
Intervention groups
Covid19 recovered patients with a history of hospitalization about a month ago who have memory impairment are randomly divided into case group (receiving Donepezil) and control group and they are evaluated about memory indexes before, one month, three month and six month after intervention.
Main outcome variables
Evaluation and comparison of Wechsler memory scale scores in case and control groups before drug administration, one month later, three months later and six months after drug administration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210816052203N1
Registration date:2021-08-24, 1400/06/02
Registration timing:prospective
Last update:2021-08-24, 1400/06/02
Update count:0
Registration date
2021-08-24, 1400/06/02
Registrant information
Name
Parham Pooladgar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 4252
Email address
parhampooladgar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-01, 1400/06/10
Expected recruitment end date
2022-04-09, 1401/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Donepezil Hydrochloride on memory impairment in patients recovered from Covid-19 with hospitalization history in comparison with the control group
Public title
The effect of Donepezil on memory impairment after Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with the age between 20- 50 years old
Memory impairment after recovery from Covid-19
Volunteer to participate in the study
Exclusion criteria:
History of previous cognitive problems
History of CVA, head trauma or Cerebral hemorrhage
History of underlying physical illnesses affecting cognitive function such as cancer, thyroid disorders, physical disorders with features of cognitive impairment such as Alzheimer's or any type of degenerative neurological disorder such as Parkinson's
History of underlying mental illnesses such as major depression, anxiety disorders and psychotic disorders
Use of drugs that affect cognitive function such as antidepressants, benzodiazepines, and anticonvulsants such as phenobarbital
Drug, stimulant and alcohol using
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into case groups (drug recipient) and control group with simple random method by using the random number table.
The random number function was used to randomize and assign individuals to groups; Randomization using Excel software is as follows:
First, in a column, the groups are entered as A, B and below each other; because the number of samples in each group is set to 35 (taking into account the sample loss), 35 A and 35 B must be entered in order and below each other. In the opposite column, random numbers are generated using the RAND command. In the next step, with using the sort command, random numbers are generated from small to large or vice versa, which causes the order of the groups A and B to be changed. In fact, using the new order, individuals are randomly assigned to the case and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single blind that data analyzer, who is a consultant professor in statistics, meantime she is aware of the general objectives of the research, she is kept blind, in such a way that meantime each participant is assigned a code and participants are informed about the study process and how to assign groups, are classified randomly with using the table of random numbers in the case and control groups. The statistics counselor is informed about the objectives and general process of the research, but in order to prevent her possible bias in analyzing the data, the code of the control group and the case group is not mentioned and she is informed at the end of the study.
Placebo
Not 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, Etemadzadeh Avenue, West Fatemi Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-08-15, 1400/05/24
Ethics committee reference number
IR.AJAUMS.REC.1400.125
Health conditions studied
1
Description of health condition studied
Memory impairment due to Post acute COVID-19 syndrome (LONG-Covid Syndrome)
ICD-10 code
B97.21
ICD-10 code description
SARS-associated coronavirus as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Score of Wechsler Memory Scale Test
Timepoint
Measurement of memory indices at the beginning of the study (before intervention), one month later, three months later and six months after the intervention
Method of measurement
The Wechsler Memory Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group is treated with Donepezil Hydrochloride with the brand name Aricept at a dose of 5 mg (half a tablet for the first 5 nights and then one tablet overnight for 3 months and from 3 months to 6 months after starting the drug are reached the dose10 mg daily). This drug is FDA-APPROVED for the treatment of Alzheimer's disease and is currently routinely prescribed in Iran.
Category
Treatment - Drugs
2
Description
Control group: This group is not face to special intervention and is examined in parallel with the case group in terms of memory indexes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khanevadeh Hospital (AJA)
Full name of responsible person
Mehdi Sakhabaksh
Street address
Khanevadeh Hospital of AjA University of Medical Science, Kaj Avenue, Shariati Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
16411-16139
Phone
+98 21 7750 7512
Email
drsakha2013@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zoshk
Street address
AJA University of Medical Sciences, Etemadzadeh Avenue, West Fatemi Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14117118541
Phone
+98 21 8609 6350
Email
drsakha2013@gmail.com
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
Mehdi Sakhabakhsh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Khanevadeh Hospital of AJA University of Medical Sciences, Kaj Avenue, Shariati Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
16139-16411
Phone
+98 21 7750 7512
Email
drsakha2013@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mehdi Sakhabakhsh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Khanevadeh Hospital (AJA), Kaj Avenue, Shariati Street, Tehran, Iran
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Yes - There is 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
Not applicable
Title and more details about the data/document
The clinical study report, study protocol and results will be published in the journal for the use of other researchers while maintaining the confidentiality of participants' individual information with their consent.
When the data will become available and for how long
6 month after publish of a journal
To whom data/document is available
All medical professionals and scientists
Under which criteria data/document could be used
If people need more information, they can ask the project supervisor.
From where data/document is obtainable
Dr. Mehdi Sakhabakhsh - AJA University of Medical Sciences
drsakha2013@gmail.com
What processes are involved for a request to access data/document
If people need more information, they can ask the project supervisor