Investigating the effect of Famotidine on cognitive and behavioral dysfunctions induced by COVID-19: A randomized double blind and placebo controlled clinical trial
The effect of Famotidine on cognitive and behavioral dysfunctions induced by COVID-19
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
This study will be performed on patients with COVID-19 attending Imam Khomeini Hospital in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: History of hospitalization due to COVID-19 - At least 20 days from the onset of symptoms, and 7 days from the last day of symptoms passed - Diagnosis of cognitive impairment (score 23 or less in MMSE test, or score 22 or less in MoCA test) - Age between 18-65. Exclusion criteria: Being psychotic - Presence of other psychiatric disorders - Using other psychiatric drugs or any drug which can affect cognitive performance - History of ECT during past 2 months - Presence of thyroid disease - Presence of kidney disease - Presence of liver disease - History of cognitive impairment or dementia - Pregnant or lactating women
Intervention groups
Intervention group: Famotidine 80 mg per day for 3 months. Control group: Placebo for 3 months.
Main outcome variables
Severity of cognitive impairments
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N138
Registration date:2021-08-03, 1400/05/12
Registration timing:prospective
Last update:2021-08-03, 1400/05/12
Update count:0
Registration date
2021-08-03, 1400/05/12
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Famotidine on cognitive and behavioral dysfunctions induced by COVID-19: A randomized double blind and placebo controlled clinical trial
Public title
Famotidine for the improvement of cognitive impairments in COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of hospitalization due to COVID-19
At least 20 days from the onset of symptoms, and 7 days from the last day of symptoms passed
Diagnosis of cognitive impairment (score 23 or less in MMSE test, or score 22 or less in MoCA test)
Age between 18-65
Exclusion criteria:
Being psychotic
Presence of other psychiatric disorders
Using other psychiatric drugs or any drug which can affect cognitive performance
History of ECT during past 2 months
Presence of thyroid disease
Presence of kidney disease
Presence of liver disease
History of cognitive impairment or dementia
Pregnant or lactating women
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization: using blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups)
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
IR.TUMS.DDRI.REC.1400.019
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
Severity of cognitive impairment
Timepoint
Baseline and months 1.5 and 3
Method of measurement
by Mini mental state Exam (MMSE), Montreal Cognitive Assessment (MoCA), Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Famotidine 80 mg per day for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Placebo for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Prof. Mohammad Reza Mohammadi
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mohammadimr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2021 to 2026
To whom data/document is available
academic researchers
Under which criteria data/document could be used
users should cite the resource of data
From where data/document is obtainable
Prof Shahin Akhondzadeh
What processes are involved for a request to access data/document