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Evaluation of the effects of Annual SZ drug on modulating immune responses and efficacy against COVID-19 infection: a randomized clinical trial

Protocol summary

Study aim
Evaluation of the effects of Annual SZ drug on modulating immune responses and efficacy against COVID-19 infection Determination of the number and function of lymphocytes along with the average changes of cytokine IL-6, IFNγ and IL-4 in the group receiving the Annual SZ drug compared with the control group
Design
A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 80 patients. The stratified randomized block design and sealed envelopes are used for randomization.
Settings and conduct
This study will be conducted in the Payambar Azam Educational, Therapeutic and Research Complex, Bandar Abbas, Iran. Blood samples will be taken before the intervention and on the 7th and 14th days after the intervention and flow cytometry, ELISA, CBC, and CRP tests will be performed. This is a double-blinded study. Blinding of the patient is done by using a placebo. To blind the physician, medication packages are prepared in advance and treating physician does not know the contents of the package.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Signing an informed consent form, Both genders from 20 to 50 years old, Definite infection of COVID-19 Exclusion criteria: Age less than 20 and more than 50 years, Pregnancy, People with Immunodeficiency, cardiac arrhythmia, kidney, liver, metabolic, mental, skin or malignant diseases.
Intervention groups
The intervention group is the group that is currently suffering from COVID-19 and receiving Annual SZ drug. The control group is patients who are currently infected with COVID-19 and are receiving national protocol drugs.
Main outcome variables
CD4, CD8, PD-1, IL-4, IL-6, IFNγ ; Annual SZ effects and effectiveness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201001048894N2
Registration date: 2022-09-04, 1401/06/13
Registration timing: prospective

Last update: 2022-09-04, 1401/06/13
Update count: 0
Registration date
2022-09-04, 1401/06/13
Registrant information
Name
Afshin Samiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3371 0373
Email address
afshin.samiei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Annual SZ drug on modulating immune responses and efficacy against COVID-19 infection: a randomized clinical trial
Public title
Effects of Annual SZ drug on modulating immune responses and efficacy against COVID-19 infection
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with COVID-19 disease or control group according to specified grouping Both genders from 20 to 50 years old Definite infection with COVID-19 (people whose PCR is positive, HRCT is clear evidence of infection and have common symptoms of moderate disease of Covid-19 Signing an informed consent form
Exclusion criteria:
Age less than 20 years and more than 50 years Pregnancy People with cardiac arrhythmia, kidney, liver, metabolic or malignant diseases Mental or skin diseases (rash, dermatitis, psoriasis) Immunodeficiency diseases Acute patient conditions and severe illness, the patient has shortness of breath, blood oxygen drop and the disease is worsening
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: In this study, we perform randomization using the method of Stratified Randomized Block Design. In this way, we use even blocks of four. In this section, we have two classes, one class has no history of receiving any vaccine and the other class has already received every dose of Sinopharm vaccine and more than 4 months have passed since their second dose. Then, in these two floors, we perform the randomized block method separately. The purpose of this work is to control the effect of vaccination.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double-blind method using a placebo that has the same color, smell, and taste as the original drug but does not have the active ingredient. Also, Pharmaceutical packages will prepare in advance, and each patient will receive a unique code of Pharmaceutical package, so the treating physician does not know the package contents too.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committees of Tarbiat Modares University
Street address
Jalal AleAhmad
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2022-08-27, 1401/06/05
Ethics committee reference number
IR.MODARES.REC.1401.112

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
Immune system parameters
Timepoint
Before intervention and 7, 14 days after intervention
Method of measurement
Using flow cytometry and enzyme-linked immunosorbent assay (ELISA) tests

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group is infected with COVID-19 and receives Annual SZ as a treatment. This medicine is a herbal product obtained from the Sweet wormwood plant (with the scientific name Artemisia annua), its active ingredient is artemisinin. It has a concentration of 5mg/ml. The dosage for patients with the moderate stage of the disease is 2mg/kg/day, equivalent to 7 ml of syrup every 6 hours for 14 days. This drug is in the form of an oral syrup and it was produced by the university-based knowledge company of Salamat Zendegi Aramesh.
Category
Treatment - Drugs

2

Description
Control group: This group is infected with COVID-19 and receives the routine drugs of the national protocol as treatment. There is no intervention in this group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Payambar Azam Educational, Therapeutic and Research Complex
Full name of responsible person
Ehsan Soltaninejad Boustani
Street address
Jomhori Eslami Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915595
Phone
+98 76 3334 7000
Email
Soltaninejad.ehsan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teymour Aghamolaei
Street address
Shafa Ave.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915189
Phone
+98 76 3333 7192
Email
research@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
60
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

2

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Amir Abdollah zadeh
Street address
Jalal AleAhmad
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 2009
Email
Res@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
40
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
Tarbiat Modares University
Full name of responsible person
Masoumeh Ebtekar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Immunology Department, Faculty of Medical Sciences, Trabiat Modares University, Jalal AleAhmad St.
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3891
Email
ebtekarm@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Masoumeh Ebtekar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Immunology Department, Faculty of Medical Sciences, Trabiat Modares University, Jalal AleAhmad St.
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3891
Email
ebtekarm@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Afshin Samiei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology, School of Medicine, Hormozgan University of Medical Sciences, Emam Hossein Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0373
Email
afshin.samiei@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
only outcome information will be presented
When the data will become available and for how long
3 month after publishing the results
To whom data/document is available
everyone
Under which criteria data/document could be used
not restricted
From where data/document is obtainable
ebtekarm@modares.ac.ir afshin.samiei@gmail.com
What processes are involved for a request to access data/document
sending an e-mail
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