Assessment The effect of resveratrol supplementation on some inflammatory factors in patients with severe COVID19
Design
This study is a two arm parallel groups clinical trial that will be done in Ahvaz hospital. Randomization is done through block method. Sample size of this study is 60 patients that divided equally into two groups include intervention and control groups .This is a phase 3 clinical trial.
Settings and conduct
This study is a two arm parallel groups clinical trial that will be done in Ahvaz hospital. In this study, blindness is not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
chain reaction (PCR) confirmed infection with COVID19 ; Lung involvement confirmed with chest imaging; Hospitalized with: Fever (axillar or oral temperature ≥ 38.0 °centigrade(C) or ≥38.6°centigrade tympanic or rectal) or respiratory rate >24/min or cough; Less than 8 days since illness. Non-inclusion criteria: Autoimmune diseases (lupus, MS, etc.); Hepatic failure; Hepatit B, C; pregnant and lactating women
Intervention groups
Both case and control group will be received routine drugs.
1. Intervention group: Resveratrol produced by Sumabe company, one Tab, daily until 14 days.
2. control group: received routine drugs.
Main outcome variables
Time to clinical recovery, respiratory signs, Intubation rate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200112046089N1
Registration date:2020-06-25, 1399/04/05
Registration timing:registered_while_recruiting
Last update:2020-06-25, 1399/04/05
Update count:0
Registration date
2020-06-25, 1399/04/05
Registrant information
Name
Arash Alghasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3289
Email address
arashalqasi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-14, 1399/03/25
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Resveratrol on the effectiveness of antiviral drug regimen in patients with COVID-19
Public title
Resveratrol in COVID19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Polymerase chain reaction (PCR) confirmed infection with SARS CoV2
Lung involvement confirmed with chest imaging
Hospitalized with: Fever (axillar or oral temperature ≥ 38.0 °centigrade(C) or ≥38.6°centigrade tympanic or rectal) or Respiratory rate >24/min Or Cough
Less than 8 days since illness onset
Willingness of study participant to accept random assignment to any treatment arm
Acceptance of non-participation in another study before the 28th day of the study
Exclusion criteria:
Autoimmune diseases (lupus, MS, etc.)
Hepatic failure
Hepatit B and C
pregnant and lactating women
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two therapeutic groups by block randomization method using blocks of size 6. Individuals are the randomization unit , making a random sequence is by using statistical software(WinPepi11.0). Allocation concealment is by assigning unique codes
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
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2020-05-16, 1399/02/27
Ethics committee reference number
IR.AJUMS.REC.1399.175
Health conditions studied
1
Description of health condition studied
COVID19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Recovery time
Timepoint
Duration of treatment
Method of measurement
Evaluation of clinical symptoms
2
Description
Repiratory signs
Timepoint
daily
Method of measurement
clinical evaluation and questionnaire
3
Description
Pulmonary Condition
Timepoint
Before intervention and 14 days after intervention
Method of measurement
CT scan
Secondary outcomes
1
Description
Blood oxygen saturation percentage
Timepoint
Before and 14 days after starting treatment
Method of measurement
Pulse oximeter
2
Description
C-Reactive Protein (CRP)
Timepoint
Before and fourteen days after starting treatment
Method of measurement
ٍELISA (enzyme-linked immunosorbent assay)
3
Description
IL6
Timepoint
Before and 14 days after starting treatment
Method of measurement
ELISA (enzyme-linked immunosorbent assay)
4
Description
IL1
Timepoint
Before and 14 days after starting treatment
Method of measurement
ELISA (enzyme-linked immunosorbent assay)
5
Description
CBC
Timepoint
Before and 14 days after starting treatment
Method of measurement
Cell Counter
Intervention groups
1
Description
Intervention group: 1 Tab resveratrol (500mg) from Sumabe, daily until 14 days in addition to routine drugs.
Category
Treatment - Drugs
2
Description
Control group: this group doesn't receive extra drugs and receive routine drugs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Arash Alghasi
Street address
Razi hospital, Felestin boulevard, Amanieh
City
Ahvaz
Province
Khouzestan
Postal code
6155819953
Phone
+98 61 3555 0592
Email
arashalqasi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohamad Badavi
Street address
Vice Chancellor of Research and Technology; Main building of Ahvaz University of Medical Science, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3311 3815
Email
Badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Arash Alghasi
Position
Assistant Professor of Pediatric Hematology and Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Hematology and Oncology
Street address
Ahvaz Shahid Baghaei 2 hospital; Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3374 3289
Email
alghasi-a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Reza Mahmoudian-Sani
Position
Assistant Professor of Molecular Medicine School of Medicine
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Ahvaz Shahid Baghaei 2 hospital; Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3374 3289
Email
mohamadsani495@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Arash Alghasi
Position
Assistant Professor of Pediatric Hematology and Oncology Department of Pediatrics, School of Medicin
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Hematology and Oncology
Street address
Ahvaz Shahid Baghaei 2 hospital; Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3374 3289
Email
alghasi-a@ajums.ac.ir
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