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Evaluation the Efficacy of CURCUDEN in Patients with COVID-19 Pneumonia

Protocol summary

Study aim
Evaluating the effectiveness of CURCUDEN products as adjunctive therapy in the treatment of pneumonia in patients with COVID-19
Design
A phase 3 randomized clinical trial with control and intervention groups, double blinded,20 patients, allocated concealment by the central randomization method.
Settings and conduct
Intervention group receives 2 capsules of CURCUDEN® every 12h with the recommended treatment regimen for COVID-19 according to the national protocol.From the day of entrance,the Sepsis-related Organ Failure Assesment standard for calculating respiratory,cardiovascular,neurological,renal,coagulation and hepatic function is calculated and its average is reported.Also,the criterion for classification of 7 (category-ordinal scale), complete counting and differentiation of blood cells (CBC diff, acute phase C protein, erythrocyte sedimentation rate and prothrombin time , lactate dehydrogenase, creatine phosphokinase, ferritin, creatinine, and the National Early Warning Criteria 2 were measured on days 1, 5, and fourteen of treatment, compared with control group. Measurements of interleukin 6 levels, RT-PCR virus testing, and CT scans of the lungs are also performed on days one and five of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Virological diagnosis of SARS-CoV-2 infection by RT-PCR Positive imaging findings: Condensation, Grand Glass turbidity or bilateral pulmonary infiltration on CT scan or Chest X-ray Need to get extra oxygen to maintain SO2> 94% or PaO2 / FiO2> 300 Exclusion criteria : less than 18 years Septic shock Pregnancy and lactation Intubated and under mechanical ventilation Allergic to curcumin Admitted to the ICU
Intervention groups
Every 12h, Intervention group received 2 CURCUDEN capsules & Control group, takes 2 placebos in addition to the main treatment protocol
Main outcome variables
SOFA; RT-PCR; CPK; CRP; Ferritin; IL-6

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170128032241N3
Registration date: 2020-08-17, 1399/05/27
Registration timing: registered_while_recruiting

Last update: 2020-08-17, 1399/05/27
Update count: 0
Registration date
2020-08-17, 1399/05/27
Registrant information
Name
Maryam Mohajeri
Name of organization / entity
Alborz Nanomed Tech Co.
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 9151
Email address
info@nanomed.ws
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Efficacy of CURCUDEN in Patients with COVID-19 Pneumonia
Public title
Evaluation the Efficacy of CURCUDEN 35 in Patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Virological diagnosis of SARS-CoV-2 infection by RT-PCR Positive imaging findings: Condensation, Grand Glass opacity or bilateral pulmonary infiltration on CT scan or Chest X-ray Need to get extra oxygen to maintain SO2> 94% or PaO2 / FiO2> 300
Exclusion criteria:
Age less than 18 years The patient has septic shock Pregnancy and lactation The patient is intubated and under mechanical ventilation The patient was admitted to the ICU Having an allergy to curcumin
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Using the table of random numbers, we assign patients codes in the specified range, then categorize the individual codes into the intervention group and the pair codes into the control group. The central randomizing method is used for allocation concealment. For this purpose, even and odd codes are provided to the researcher conducting the project, and sampling is performed in the medical center of Taleghani Hospital. Based on the order in which the participants entered the study, the researcher randomly assigned the participant to one of the two groups of treatment and control (even and odd codes). At the end of the study, and after the intervention, unblinding will be done with the Post-study unblinding model to prevent any bias in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
We mark drug with code A and placebo with the code B, only the analyst is aware of this codes, each group of patients receive A or B randomly, the physician and the patient are not aware of this codes.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti Medical University
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-05-10, 1399/02/21
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.085

Health conditions studied

1

Description of health condition studied
covid-19 pneumonia Disease
ICD-10 code
U07.1
ICD-10 code description
covid-19 pneumonia

Primary outcomes

1

Description
1- Evaluation of clinical variables involved in patients' recovery including mechanical ventilation
Timepoint
On days 1, 5 and 14 of the start of treatment
Method of measurement
Spirometry test

2

Description
2- Organ failure and comparison of these results in the two groups of treatment and control
Timepoint
On days 1, 5 and 14 of the start of treatment
Method of measurement
Examination and registration of clinical signs

3

Description
3- Mortality and comparison of these results in the two groups of treatment and control
Timepoint
On days 1, 5 and 14 of the start of treatment
Method of measurement
Record vital signs

4

Description
4- The length of hospital stay and comparison of these results in the treatment and controlgroups
Timepoint
On days 1, 5 and 14 of the start of treatment
Method of measurement
Evaluation of the length of hospital stay

5

Description
5- Length of ICU hospitalization and comparison of these results in the treatment and controlgroups
Timepoint
On days 1 and 5 of the start of treatment
Method of measurement
Check the period of hospitalization in the ICU

6

Description
6- Receiving oxygen and comparing these results in the treatment and control groups
Timepoint
On days 1, 5 and 14 of the start of treatment
Method of measurement
Nursing information on the use of oxygen capsules

7

Description
7- The length of the negative period of PCR test and comparison of these results in thetreatment and control groups
Timepoint
On days 1 and 14 of the start of treatment
Method of measurement
Polymerase Chain Reaction

8

Description
8- Comparison of interleukin-6 levels in the treatment and control groups
Timepoint
On days 1 and 14 of the start of treatment
Method of measurement
Polymerase Chain Reaction

9

Description
9- Comparison of patients' ferritin levels in treatment and control groups
Timepoint
On days 1, 5 and 14 of the start of treatment
Method of measurement
Blood biochemical test

10

Description
10- Comparison of patients' CRP levels in treatment and control groups
Timepoint
On days 1, 5 and 14 of the start of treatment
Method of measurement
Blood biochemical test

11

Description
11- Length of improvement period of patients' lung imaging results and comparison of results intreatment and control groups
Timepoint
On days 1 and 5 of the start of treatment
Method of measurement
lung CT Scan

12

Description
12- Lymphocyte count and comparison of results in treatment and control groups
Timepoint
On days 1, 5 and 14 of the start of treatment
Method of measurement
Blood biochemical test

13

Description
13- Length of respiratory symptoms and comparison of results between treatment and controlgroups
Timepoint
On days 1, 5 and 14 of the start of treatment
Method of measurement
Check spirometric test information

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients with covid-19 who use curcumin in addition to first-line drugs during treatment. Intervention group receive two capsules of CURCUDEN® every 12 hours in addition to the main treatment based on national guidelines for the treatment of hospitalized patients with COVID-19. Curcuden 35 is a drug used by Alborz Nanomed tech Company.
Category
Treatment - Drugs

2

Description
Control group: Patients with covid-19 who use placebo in addition to first-line drugs during treatment. Control group receive two capsules of placebo every 12 hours in addition to the main treatment based on national guidelines for the treatment of hospitalized patients with COVID-19.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
ماریا توکلی اردکانی
Street address
CHAMRAN HIWAY, YAMAN ST., SHAID ARABI ST. TALEGHANI Hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1100
Email
taleghani@sbmu.ac.ir
Web page address
http://taleghani.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli Ardakani
Street address
chamran Hiway, Yaman St. Arabi St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mobtaker Electric Company ( METEC )
Proportion provided by this source
50
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
Industry

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Mohajeri
Street address
chamran Hiway, Yaman St. Arabi St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Alborz Nanomed-Tech Company
Proportion provided by this source
50
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
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Alborz Nanomed Tech. Co.
Full name of responsible person
Mehran Azodi
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Industrial Engineering- System Management
Street address
No.122, Dr. Hooshyar St., Azadi Ave., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1341879796
Phone
+98 21 6605 7174
Email
mohajeri_maryam@yahoo.com
Web page address
http://www.nanomed.ws

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz Nanomed Tech Co.
Full name of responsible person
Maryam Mohajeri
Position
CEO, R&D manager
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Genetics, Nanomedicine
Street address
No. 122, Dr.HoosSt., Azadi Ave., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1341879796
Phone
+98 21 6600 0561
Fax
Email
mohajeri_maryam@yahoo.com
Web page address
http://nanomed.ws/

Person responsible for updating data

Contact
Name of organization / entity
Alborz Nanomed Tech Co.
Full name of responsible person
Narges Shakeri
Position
IT expert
Latest degree
Bachelor
Other areas of specialty/work
Information Technology
Street address
No. 122, Dr. Hooshyar St., Azadi Ave., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1341879796
Phone
+98 21 6605 7174
Fax
Email
narges.shaker89@gmail.com
Web page address
http://nanomed.ws

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
No - There is not 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
No - There is not 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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