Treatment and reduction of the course of treatment of patients with Covid-19
Design
Clinical trial with control group, with parallel groups, double-blind, randomized based on hospital admission code, phase 2 on 60 patients
Settings and conduct
In clinical trials, patients are divided into two general categories:
The first group is the case group, the second group is the control group. In this study, samples are selected randomly among all clients of Imam Hossein (AS) hospital in Tehran with the symptoms specified in the scoring table. The odd admission codes are allocated into the first group and the even admission codes are allocated into the second group.
The number of selected samples in each group is 30 people.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with COVID-19. Exclusion criteria: none.
Intervention groups
The first group (A): the group treated with the drug Anval SZ + azithromycin.
The second group (B): the group that receives treatment based on the country's routine protocol + azithromycin
Main outcome variables
A history of close contact with a person with covid 19 over the past two weeks
Oral fever with more than 38 degrees Celsius (or equivalent) or tremors
Sore throat or severe feeling of dry throat
Dry cough
Muscle diffuse pain
Clear runny nose
Frequent sneezing
Headache
nausea and vomiting
Diarrhea
Pain or heaviness in the chest
Shortness of breath
Acute olfactory disturbance
Acute taste disturbance
Pulse oximetry less than 93%
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200607047682N1
Registration date:2020-07-27, 1399/05/06
Registration timing:retrospective
Last update:2020-07-27, 1399/05/06
Update count:0
Registration date
2020-07-27, 1399/05/06
Registrant information
Name
Zuhair Saraf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3565
Email address
hasan_zm@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2020-07-11, 1399/04/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the use of Annual SZ drug in the treatment of patients with Covid-19 disease in Emam Hosein hospital in Tehran.
Public title
Clinical trial of Annual SZ drug in Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pationt infected with covid19
Exclusion criteria:
Age
From 16 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to the case and control groups based on the admission codes, so that the even admission code is in the case group and the odd admission code is in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research and Technology, Shahid Beheshti University
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2020-06-07, 1399/03/18
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.158
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified
Primary outcomes
1
Description
Fever - People who have a fever of more than 38 degrees and their score in the questionnaire is 1 or more than one
Timepoint
At the beginning of the study (before the intervention) and 3, 5, 7, 9, 11, 14 days after the start of use
Method of measurement
Mercury thermometer
2
Description
Blood oxygen level 93 and above - People who have a blood oxygen level of less than 93 and get number one in the questionnaire
Timepoint
At the beginning of the study (before the intervention) and 3, 5, 7, 9, 11, 14 days after the start of use
Method of measurement
With digital pulse oximetry device
3
Description
Coughs that have a score of one or more in the questionnaire
Timepoint
At the beginning of the study (before the intervention) and 3, 5, 7, 9, 11, 14 days after the start of use
Method of measurement
Based on the follow-up and the patient's report
4
Description
CRP that has a score of one or more in the questionnaire
Timepoint
On the day of starting (before treatment) 3, 5, 11 after starting treatment
Method of measurement
With the help of laboratory kit and agglutination method
5
Description
HRCT that has a score of one or more based on the questionnaire
Timepoint
The first day before starting treatment and the 30th day after starting treatment
Method of measurement
With the help of CT scan machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group treated with Anval SZ + azithromycin Anval S is a herbal product derived from the herb. The active ingredient is artemisinin, which is used in the treatment of malaria. The dose of TDS is 1-1.5 mg / kg. The time of use is 14 days for definite recovery, this medicine is in the form of oral syrup and is produced by the knowledge-based university of the Health of Living Life, observing all health principles.
Category
Treatment - Drugs
2
Description
The group that receives treatment according to the national routine protocol + azithromycin. The drugs in this group are hydroxychloroquine and keltra. Chloroquine is an anti-malarial drug and the dose is different depending on the phase of the disease and according to the national protocol. Hydroxychloroquine 200 mg daily for 8 days is administered as two stats together and then one every 12 hours for 5 days. About.Cltra tablets (lupinavir / ritonavir): 2 tablets of 50/200 every 12 hours for at least 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hoseyn Hospital
Full name of responsible person
Mohammad Farhbakhsh
Street address
South Shahid Madani Ave
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
info@ehmc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Velenjak
City
Teran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Salamat Zendegi Aramesh com1000pany
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Chegini
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Mdares Ave
City
Borujerd
Province
Tehran
Postal code
6915136111
Phone
0098 42518000
Email
H.chegini2010@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares Univercity
Full name of responsible person
Zuhair Sarraf
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Amir abad blvd
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 8288 3565
Email
hasan_zm@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Chegni
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Modares Ave
City
Borujerd
Province
Lorestan
Postal code
6915136111
Phone
0098 42518000
Email
H.chegini2010@yahoo.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