Determining the effectiveness of Methylene Blue on treatment of the Coronavirus Patients in Chaharmahal Va Bakhtiari province
Design
A randomized, controlled trial, based on patients with Covid-19, which has two parallel groups.
Settings and conduct
Shahrekord university of medical sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with no underlying disorders, Patients who are free of any kidney (creatinine test), liver (liver and LFT tests), and heart (echocardiography) damage . The age of inclusion in the study is 20-50 years. Nasopharyngeal RT-PCR test sample is to be positive. Patients are to have lung damage scanned through CT scan. patients are to have no history of viral infections with hepatitis and AIDS. Patients are to not have received recombinant treatments. Patients are to not have G6PD enzyme defect. O2Saturation of patients is to be less or equal to 85.
Exclusion: Pregnant women and women who are planning to become pregnant. Breastfeeding women. People with a history of allergies to methylene blue. People with a BMI above 30. People with kidney, heart, lung disorders.
Investigation the Effects of Methylene Blue on Coronavirus Patients treatment
Public title
Effect of Methylene Blue in treatment of Coronavirus Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are to be free of any underlying disorders.
Patients are to be free of any kidney (creatinine test), liver (liver and LFT tests), and heart damages.
The age of inclusion in the study is to be between 20-50 years
Nasopharyngeal RT-PCR test sample is to be positive
Diagnosed with lung damages through CT scan
Have no history of viral infections with hepatitis and AIDS
Have not had received recombinant treatments
Have not had G6PD enzyme defect
O2Saturation of patients is to be less or equal to 85
Exclusion criteria:
Pregnant women and women who are planning to become pregnant
Breastfeeding women
People with a history of allergies to methylene blue
People with a BMI above 30
People with kidney, heart, lung disorders
Age
From 20 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization
randomization unit: individualized
randomization tool: through the randomization website https://random.org/lists/. Simple randomization will be achieved through numbers randomly generated by the website, in a way that according to the generated list, the target individuals will be randomly divided into two groups of control and treatment (by Methylene blue)
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, Researchers, Health personnel, data collectors, and those evaluating the outcome will be blinded throughout this study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IR.SKUMS.REC.1400.111
Street address
Rahmatyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Approval date
2021-08-14, 1400/05/23
Ethics committee reference number
IR.SKUMS.REC.1400.111
Health conditions studied
1
Description of health condition studied
coronavirus infection
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Blood O2 saturation
Timepoint
daily
Method of measurement
saturation %
Secondary outcomes
empty
Intervention groups
1
Description
In this clinical trial study, 60 patients with Covid-19 admitted to Hajar Hospital in Shahrekord with positive PCR test and O2-Saturation equal to 85 and less are selected and randomly divided into two groups of 30. Control and Intervention. Treated group: O2-Saturation equal to 85 and less. All the 30 patients will be matched in terms of age and gender. Prior to the study, all patients will be tested for biochemical factors such as CRP, methemoglobin, ferritin, serum creatinine, SGOT, SGPT, and LDH, Ddimer, CRP, and O2-Saturation levels will be measured daily. For patients in the treatment group, methylene blue (at the time of hospitalization) with a concentration of 34 mg / kg is given for 4 days, orally, along with the conventional treatments (routine treatment), Remdesiver and corticosteroids. At the end of four days, patients are assessed for improvement in indicators (general condition, O2-Saturation level, and biochemical factors) compared to the control group.
Category
Treatment - Drugs
2
Description
In this clinical trial study, 60 patients with Covid 19 admitted to Hajar Hospital in Shahrekord with positive PCR test and O2-Saturation equal to 85 and less are selected and randomly divided into two groups of 30. Control group:O2-Saturation equal to 85 and less. The 30 patients in both groups will be matched in terms of age and gender. Prior to the study, all patients will be tested for biochemical factors such as CRP, methemoglobin, ferritin, serum creatinine, SGOT, SGPT, and LDH, Ddimer, CRP, and O2-Saturation levels are measured daily. The control group will only receive the usual treatment (routine treatment) of Remdesiver and corticosteroids with placebo. At the end of four days, patients are assessed for improvement in indicators (general condition, O2-Saturation level, and biochemical factors).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Hajar Hospital
Full name of responsible person
Dr. Akbar Soleimani
Street address
Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 1471
Email
j_saffari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Mehraban Sadeghi
Street address
Rahmatyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 1471
Email
j_saffari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Akbar Soleimani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Rahmatyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 35 3333 1471
Email
j_saffari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Akbar Soleimani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Rahmatyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 1471
Email
j_saffari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Akbar Soleimani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Rahmatyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 1471
Email
j_saffari@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 will be shared
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Provide other scientific research
From where data/document is obtainable
Dr Akbar Soleimani
What processes are involved for a request to access data/document