Evaluation of the effect of Grapex on the alternations of clinical symptoms and laboratory findings in patients with coronary hospitalization in Abadan hospitals.
Design
Clinical trial with control group, and parallel groups, double-blind, randomized, phase 3 on 80 patients
Settings and conduct
investigation of clinical symptoms and laboratory findings due to use of Grapex on covid-12 patients in abadan hospitals.
Patients and researchers are blinded as double blind.
Include treatment and control groups.
Control group: The patients receive county protocol with placebo
Treatment group: The patients receive county protocol with Grapex 200 mg, twice a day for 2 weeks.
The desired outcomes are compared before treatment and at the discharge time.
Participants/Inclusion and exclusion criteria
COVID-19 patients that have positive PCR test
COVID-19 patients that have positive by CT Scan for COVID-19.
Exclusion criteria: Pregnant or breast feeding women, Patients under 18 years of age, Any life-threatening factor
Intervention groups
Control group: The patients receive county protocol with placebo
Treatment group: The patients receive county protocol with Grapex 200 mg, twice a day for 2 weeks.
Main outcome variables
Time to clinical alternations defined as start of taking medication time to Discharge Time.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200921048783N1
Registration date:2020-12-06, 1399/09/16
Registration timing:prospective
Last update:2020-12-06, 1399/09/16
Update count:0
Registration date
2020-12-06, 1399/09/16
Registrant information
Name
Hoda Mojiri-Forushani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 5361
Email address
dr.mojiri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-08, 1399/10/19
Expected recruitment end date
2021-04-08, 1400/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Grapex on the alternations of clinical symptoms and laboratory finding on COVID19.
Public title
Effect of GRAPEX in treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with covid19 by positive PCR test.
Patients diagnosed with covid19 by positive CT scan evaluation
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researchers are blinded as double blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Abadan school of Medical Sciences
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
6319811154
Approval date
2020-08-25, 1399/06/04
Ethics committee reference number
IR.ABADANUMS.REC.1399.098
Health conditions studied
1
Description of health condition studied
covid19
ICD-10 code
U07
ICD-10 code description
Other coronavirus as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Time to clinical alternations defined as start of taking medication time to Discharge Time.
Timepoint
The beginning of the study ,the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
Method of measurement
Medical record
Secondary outcomes
1
Description
Complete Blood Count
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
2
Description
C-reactive-protein
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
3
Description
SER
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
4
Description
creatinine
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
5
Description
Aspartate amino transferase
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
6
Description
Alanine amino transferase
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
7
Description
Prothrombin time
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
8
Description
Partial Thromboplastin time
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
9
Description
cough
Timepoint
The beginning of the study ,the seventh day, the fourteenth day
Method of measurement
Clinical observation and examination
10
Description
level of consciousness
Timepoint
The beginning of the study ,the seventh day, the fourteenth day
Method of measurement
Using the Glasgow Coma scale
11
Description
Arterial oxygen saturation
Timepoint
The beginning of the study ,the seventh day, the fourteenth day
Method of measurement
Blood sample
12
Description
Blood pressure
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Clinical examination
13
Description
Level of serum sodium
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
14
Description
Level of serum potassium
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
15
Description
BUN
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
16
Description
INR
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
17
Description
Mortality rate
Timepoint
Daily
Method of measurement
Blood sample
18
Description
Number of days of hospitalization
Timepoint
Daily
Method of measurement
Medical record
19
Description
Alkaline phosphatase
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Blood sample
Intervention groups
1
Description
Intervention group: Patients receiving standard country protocol drugs with Grapex 200 mg twice a day until the patient's clinical symptoms improve .
Category
Treatment - Drugs
2
Description
Control group: Patients receiving standard country protocol drugs with placebo twice a day until the patient's clinical symptoms improve .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Hoda Mojiri-Forushani
Street address
Ayatollah Taleghani Hospital; University Blvd; Nurse Square; Abadan city
City
Abadan
Province
Khouzestan
Postal code
6311911154
Phone
+98 61 5326 7800
Email
dr.mojiri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Street address
Abadan School of Medical Sciences; Beginning of the 30 meters Ave; Zolfaghari street; Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@ abadanums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Abadan 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
Abadan University of Medical Sciences
Full name of responsible person
Hoda Mojiri-Forushani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5338 4004
Email
dr.mojiri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Hoda Mojjiri-Forushani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Abadan School of Medical Sciences, Beginning of the street 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
dr.mojiri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Hoda Mojiri-Forushani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Abadan School of Medical Sciences, Beginning of the street 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
dr.mojiri@yahoo.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
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after the participants in the study are unrecognizable.
When the data will become available and for how long
The data access period after printing the article
To whom data/document is available
The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher.
From where data/document is obtainable
dr.mojiri@yahoo.com
What processes are involved for a request to access data/document
The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.The project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a period of one week.