Protocol summary

Study aim
Evaluation the effect of trans sodium crocetinate on acute respiratory distress syndrome in covid-19 patients
Design
A randomized and open controlled clinical trial with a parallel group design of 30 inpatients, randomizing with the table of random numbers.
Settings and conduct
This study will be performed on inpatients. In this study, 30 patients with covid-19 disease were selected and randomly assigned to two groups of 15 individuals. Patients in the standard diet control group will receive standard coronavirus treatment . In addition to the standard diet, patients in the treatment group will be treated with 1 mg/kg/day of trans O2 saturation, vital signs as well as adverse drug reactions. 2-On the first, third and seventh day, liver and kidney function tests and CBC will be checked. 3-At the end of treatment, the severity parameters of the disease are checked in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with clinical diagnosis for Covid-19 disease; patients with acute respiratory distress syndrome (ARDS); PF ratio (the ratio of arterial oxygen partial pressure to fractional inspired oxygen) <300; patients not having kidney, liver and heart dysfunction according to clinical and laboratory findings. Exclusion criteria: allergic reactions to saffron; pregnancy or breast-feeding; multi organ dysfunction disease.
Intervention groups
The control group receives standard anti-coronavirus drugs. In addition to the common anticorona virus drugs, the treatment group also receives trans sodium crocetinate vials.
Main outcome variables
Primary outcomes: frequency of patients mortality. Secondary outcomes: days under ventilation; hospitalization days in ICU; getting multi organ dysfunction; improving PF ratio and sofa score.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20081019001369N6
Registration date: 2020-05-17, 1399/02/28
Registration timing: prospective

Last update: 2020-05-17, 1399/02/28
Update count: 0
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
Hossein Hosseinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1193
Email address
hosseinzadehh@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of trans sodium crocetinate in respiratory distress caused by COVID-19
Public title
Clinical trial of trans sodium crocetinate against COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with clinical diagnosis for Covid-19 disease, Patients with acute respiratory distress syndrome (ARDS), Patients not having kidney, liver and heart dysfunction according to clinical and laboratory findings PF ratio (the ratio of arterial oxygen partial pressure to fractional inspired oxygen) <300 ,
Exclusion criteria:
Allergic reactions to saffron Pregnancy or breast-feeding Multi organ dysfunction disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized method according to randome numbers table
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
Medical Ethics Committee of Mashhad University of Medical Sciences
Street address
School of Pharmacy, Vakilabad 2- Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.MUMS.REC.1399.245

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 Disease

Primary outcomes

1

Description
Patients' mortality rate
Timepoint
During 7 days hospitalization
Method of measurement
Meedical Reports

Secondary outcomes

1

Description
Days under ventilation
Timepoint
During 7 days hospitalization
Method of measurement
Meedical Reports

2

Description
Hospitalization days in ICU
Timepoint
During 7 days hospitalization
Method of measurement
Medical Report

3

Description
Getting multi organ dysfunction
Timepoint
During 7 days hospitalization
Method of measurement
Clinical and laboratory evaluation

4

Description
Improving PF ration
Timepoint
daily during 7 days hospitalization
Method of measurement
ratio calculated from PaO2/FiO2

5

Description
Improving Sofa (The sequential organ failure assessment ) score
Timepoint
the first day and during 7 days hospitalization
Method of measurement
According to clinical and laboratory evaluation

Intervention groups

1

Description
Intervention group: In addition to the standard treatment regimen for COVID-19, the trans sodium crocetinate 1 mg/kg/day will be given i.v. for 1 weeks.
Category
Treatment - Drugs

2

Description
Control group: Patients will received the standard treatment regimen for COVID-19 for 7 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Amirhoushang Mohammadpour
Street address
Imam Reza Square
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3180 1592
Email
MohamadpoorAH@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah St
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Amirhoushang Mohammadpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy
Street address
School of Pharmacy, Vakilabad 2 Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1592
Fax
+98 51 1882 3251
Email
MohamadpoorAH@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Hosseinzadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacy
Street address
School of Pharmacy, Vakilabad 2 Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1193
Fax
+98 51 1882 3251
Email
hosseinzadehh@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Hosseinzadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacy
Street address
School of Pharmacy, Vakilabad 2 Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1193
Fax
+98 51 1882 3251
Email
hosseinzadehh@mums.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
Not applicable
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