Protocol summary

Study aim
Effects of nano curcumin supplementation on the reduction of inflammation and mortality in patients with coronavirus 2019 admitted to ICU ward of Tabriz Imam Reza Hospital
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial
Settings and conduct
Imam Reza Hospital, This study is a double-blind randomized clinical trial on two statistical populations, including patients with coronavirus in the ICU who receive four drugs oseltamivir, hydroxychloroquine, lopinavir, and ribavirin. Now, patients with the above conditions are divided into two groups receiving 240 mg daily oral nano curcumin and placebo recipients, both of which will have a treatment duration of 14 days. After sampling from both groups and isolating mononuclear cells (PBMC) from them, the expression levels of IL-1, IL-6, IL-17, and TNF-α genes were quantified using the Quantitative Real-Time PCR method. And after the intervention, it will be measured. On the other hand, the ELISA technique is used to evaluate the levels of IL-1, IL-6, IL-17 and TNF-α secreting cytokines.
Participants/Inclusion and exclusion criteria
• In accordance with clinical diagnosis or etiologic criteria for coronavirus pneumonia (COVID-19). • Willingness to cooperate • Age range from 18 to 8 years Not logged in: • Nutrition and antioxidant supplements and alpha-lipoic acid during one month before the study • Pregnancy and lactation • Severe immune suppression (HIV infection, long-term use of immunosuppressive agents)
Intervention groups
The intervention group will receive 240 mg nano curcumin and the control group will receive placebo capsules daily. Patients will be given daily capsules in packs containing 60 capsules and we ask patients to take three capsules daily for 14 days.
Main outcome variables
Gene expression rate; cytokine secretion rate; clinical observations; laboratory observations

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200324046851N1
Registration date: 2020-04-03, 1399/01/15
Registration timing: registered_while_recruiting

Last update: 2020-04-03, 1399/01/15
Update count: 0
Registration date
2020-04-03, 1399/01/15
Registrant information
Name
Majid Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
ahmadi.m@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-29, 1399/01/10
Expected recruitment end date
2020-04-29, 1399/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of nano curcumin supplementation on the reduction of inflammation and mortality in patients with coronavirus 2019 admitted to ICU ward of Imam Reza hospital in Tabriz
Public title
Effects of nano curcumin supplementation on the reduction of inflammation and mortality in patients with coronavirus 2019 admitted to ICU ward of imam Reza hospital in Tabriz
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of positive for coronavirus by RT-pcr Willingness to cooperate In accordance with clinical diagnosis or etiologic criteria for coronavirus pneumonia (COVID-19). Able to sign informed consent
Exclusion criteria:
Nutrition and antioxidant supplements and alpha lipoic acid during one month before study Pregnancy and lactation Severe immune suppression (HIV infection, long-term use of immunosuppressive agents) Unwillingness to continue cooperation
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Researchers, nurses, and patients have no knowledge of medication or placebo because they are distributed equally among patients and control group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Univesity Main St,Tabriz,East Azerbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-03-18, 1398/12/28
Ethics committee reference number
IR.TBZMED.REC.1398.1314

Health conditions studied

1

Description of health condition studied
COVID-2019
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Expression of peripheral blood mononuclear cell (PBMC)- Genes Expressed in Nano-Curcumin Patients with Control Group (Before and After Treatment)
Timepoint
At baseline and 14 days later
Method of measurement
Real time Polymerase chain reaction

2

Description
The secretion rate of peripheral blood mononuclear cell (PBMC)-treated cytokines in nano-curcumin patients and control group (before and after treatment)
Timepoint
At baseline and 14 days later
Method of measurement
Elisa kit

3

Description
Clinical features
Timepoint
At baseline and 14 days later
Method of measurement
Clinical observations by specialists

4

Description
Laboratory observations
Timepoint
At baseline and 14 days later
Method of measurement
Review by a pulmonary specialist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Nanocurcumin, which is curcumin, is derived from the yellow-cucumber plant, which is embedded in nano-lipid structures for further absorption. The drug is manufactured by Exir Sina. The intervention group will receive 240 mg of nano curcumin in 3 capsules of 80 mg daily.
Category
Treatment - Drugs

2

Description
Control group: The control group will receive 3 placebo capsules daily, which is similar to the nano curcumin capsule daily.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital in Tabriz
Full name of responsible person
Hamed Valizadeh
Street address
Golestan st,Tabriz, East Azerbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3334 7056
Email
Iro@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan soleimanpor
Street address
Golgasht Street, Tabriz, East Azerbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3177 1042
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Majid Ahmadi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology-Faculty of Medicine- University Ave- Tabriz-Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165648137
Phone
+98 41 3336 4665
Email
Ahmadi.m@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Ahmadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology- Faculty of Medicine- University Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165648137
Phone
+98 41 3336 4665
Email
ahmadi.m@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ramin Pourakbari
Position
Consultant
Latest degree
Bachelor
Other areas of specialty/work
Immunology
Street address
Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3177 1042
Email
Ramin.prb@gmail.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
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