Clinical Trial on Diphenhydramine Compound in Covid-19 Treatment
Design
This clinical trial is a double-blinded case-control randomized study on 120 patients. Permuted block randomization technique was used for patients randomization.
Settings and conduct
This study will be performed in Imam Ali hospital at the first 6 months of the year. Statistical analyses will be accomplished using STATA software. This study is designed double-blinded (patients and physicians). Patients of each group (case or control) will be hospitalized in a specific place and do not have any contact with patients of the opposite group.
Participants/Inclusion and exclusion criteria
Patients between 18-70 years admmited to the hospital whose diseases were confirmed by CT, RT-PCR.
Intervention groups
Diphenhydramine Compound treatment group receives standard treatment and Dighenhydramin treatment group receives standard treatment. adverse effects and desired effects will be assessed.
Main outcome variables
Clinic and Para clinic (chest ct scan and PCR)findings in COViD-19 patients. Mortality and morbidity rate in COViD-19 patinets. Duration of hospitalization.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200504047298N3
Registration date:2020-09-09, 1399/06/19
Registration timing:registered_while_recruiting
Last update:2020-09-09, 1399/06/19
Update count:0
Registration date
2020-09-09, 1399/06/19
Registrant information
Name
Zeinab Siami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4602 2136
Email address
z.siami@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial on Diphenhydramine Compound in Covid-19 Treatment
Public title
Effect of Diphenhydramine Compound in Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed Covid-19 Infection
Age between 18_70 years old
Exclusion criteria:
Cardiovascular disease
non confirmed patients
Addicted patient
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomized classification into standard treatment group and case group was performed using permuted block randomization. in this study, four-unit blocks were used. Using R software, a chain of randomized numbers comprising one to six are created to reach the desired sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, researchers, and health workers were blind.
This study is designed double-blinded. Patients of each group (case or control) will be hospitalized in a specific place and do not have any contact with patients of the opposite group. Besides, a member of the research team and a doctor of infectious diseases will prescribe according to assigned treatment codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Alborz University of Medical Sciences
Street address
Taleghani Boulevard,Taleghani square ,Karaj,Iran
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2020-04-21, 1399/02/02
Ethics committee reference number
IR.ABZUMS.REC.1399.079
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
virus identified’ is assigned to a disease diagnosis of COVID-19 confirmed by laboratory testing.
Primary outcomes
1
Description
Change of involment of lung in HRCT(High-resolution computed tomography)
Timepoint
Day 0 and 7 Days later
Method of measurement
HRCT(High-resolution computed tomography)
2
Description
Change of viral load in Real Time PCR
Timepoint
Day 0 and 7 days later
Method of measurement
Real Time PCR nasopharengeal soap
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:According to the inclusion criteria and in addition to the treatments recommended in the national guideline, all patients with Quid-19, who were divided into three groups based on clinical symptoms, mild, moderate and severe, Diphenhydramine Compound syrup is prescribed in a dose of 10 cc. It lasts every 8 hours for 7 days. Then the patient's clinical symptoms and load of PCR test and lung CT scan of the patient are evaluated at 7-day intervals
Category
Treatment - Drugs
2
Description
Control group: According to the inclusion criteria and in addition to the treatments recommended in the national guideline, all patients with Quid-19, who were divided into three groups based on clinical symptoms, mild, moderate and severe, Diphenhydramine syrup is prescribed in a dose of 10 cc. It lasts every 8 hours for 7 days. Then the patient's clinical symptoms and load of PCR test andlung CT scan of the patient are evaluated at 7-day intervals.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali hospital
Full name of responsible person
Zeinab Siami
Street address
Taleghani Boulevard,Taleghani square ,Karaj,Iran
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3271 7149
Email
z.siami@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Noorisepehr
Street address
Research center.Safarian Alley,Golshahr Avenue ,Karaj,Iran
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3271 7149
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Zeinab Siami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Karaj.azimieh.emam ali hospital.infection disease departmant
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 21 4602 2136
Fax
Email
z.siami@abzums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Zeinab Siami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Karaj.azimieh.emam ali hospital.infection disease departmant
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 21 4602 2136
Fax
Email
z.siami@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Zeinab Siami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Karaj.azimieh.emam ali hospital.infection disease departmant
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 21 4602 2136
Fax
Email
z.siami@abzums.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In internet for general population because of importance of covid_19
When the data will become available and for how long
5 years
To whom data/document is available
General population
Under which criteria data/document could be used
General
From where data/document is obtainable
Internet
What processes are involved for a request to access data/document