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Protocol summary
A randomized, phase 3, clinical trial with parallel groups and without blinding is performed on 174 patients. Simple randomization is done using online websites so that each block contains 6 patients.
A randomized, phase 3, clinical trial with parallel groups and without blinding is performed on 130 patients. Simple randomization is done using online websites so that each block contains 6 patients.
A randomized, phase 3, clinical trial with parallel groups and without blinding is performed on 174130 patients. Simple randomization is done using online websites so that each block contains 6 patients.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، بدون کور سازی ، تصادفی شده، فاز 3 بر روی 174 بیمار انجام می شود. برای تصادفی سازی از وبسایتهای آنلاین و در بلوکهای 6 تایی استفاده شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، بدون کور سازی ، تصادفی شده، فاز 3 بر روی 130 بیمار انجام می شود. برای تصادفی سازی از وبسایتهای آنلاین و در بلوکهای 6 تایی استفاده شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، بدون کور سازی ، تصادفی شده، فاز 3 بر روی 174130 بیمار انجام می شود. برای تصادفی سازی از وبسایتهای آنلاین و در بلوکهای 6 تایی استفاده شد.
General information
174
130
174130
empty
The sample size reduction from 87 to 65 participants in each group was done after the approval of the ethics committee of the university.
The sample size reduction from 87 to 65 participants in each group was done after the approval of the ethics committee of the university.
empty
کاهش حجم نمونه از 87 نفر به 65 نفر در هر گروه پس از تایید کمیته اخلاق دانشگاه انجام شد.
کاهش حجم نمونه از 87 نفر به 65 نفر در هر گروه پس از تایید کمیته اخلاق دانشگاه انجام شد.
Protocol summary
Study aim
Evaluation of methylene blue administration on mortality of patients with acute respiratory distress syndrome caused by Covid disease 19
Design
A randomized, phase 3, clinical trial with parallel groups and without blinding is performed on 130 patients. Simple randomization is done using online websites so that each block contains 6 patients.
Settings and conduct
Patients admitted to Imam Reza Hospital in Mashhad are enrolled to the study after obtaining informed consent, considering the inclusion and exclusion criteria. These patients are randomly divided into intervention and control groups.
Finally, one-month mortality is compared between the two groups.
Participants/Inclusion and exclusion criteria
1- The patient has received remdesivir and corticosteroids and antibiotics and anticoagulants
2- At least one day and at most 5 days have passed since the patient's hospitalization.
3- O2 saturation for 10 minutes without oxygen is less than 89 and more than 75
4- Age between 18 to 75 year
5- Does not have a history of G6PD Deficiency
6- Absence of chronic renal failure with GFR <30
7- Absence of heart failure with EF<40%
8- Does not have COPD with CO2>45
9- The patient is not intubated
10- Does not have systolic Blood Pressure <90
11- Do not take SSRI, MAO Inhibitor drugs
12- Has not received plasma therapy, IVIG, hemoperfusion, Tocilizumab and plasmapheresis before administration of methylene blue
13- Does not be pregnant
14- The patient should be conscious
Intervention groups
Patients who are treated with methylene blue in addition to remdesivir, anticoagulants, corticosteroids, and antibiotics form the intervention group.
In the control group, patients are treated only with remdesivir, anticoagulants, corticosteroids and antibiotics.
Main outcome variables
One-month mortality rate
General information
Reason for update
The sample size reduction from 87 to 65 participants in each group was done after the approval of the ethics committee of the university.
Acronym
IRCT registration information
IRCT registration number:IRCT20200409047007N2
Registration date:2021-11-29, 1400/09/08
Registration timing:registered_while_recruiting
Last update:2023-10-15, 1402/07/23
Update count:1
Registration date
2021-11-29, 1400/09/08
Registrant information
Name
Mohsen Seddigh-Shamsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 8818
Email address
seddighshamsim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-16, 1400/06/25
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of methylene blue on acute respiratory distress syndrome in Covid-19 disease
Public title
The effect of methylene blue on acute respiratory distress syndrome in Covid-19 disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has received remdesivir and corticosteroids and antibiotics and anticoagulants
At least one day and at most 5 days have passed since the patient's hospitalization.
O2 saturation for 10 minutes without oxygen is less than 89 and more than 75
Age between 18 to 75 year
Does not have a history of G6PD Deficiency
Absence of chronic renal failure with GFR <30
Absence of heart failure with EF<40%
Does not have COPD with CO2>45
The patient is not intubated
Does not have systolic Blood Pressure <90
Do not take SSRI, MAO Inhibitor drugs
Has not received plasma therapy, IVIG, hemoperfusion, Tocilizumab and plasmapheresis before administration of methylene blue
Does not be pregnant
The patient should be conscious
Exclusion criteria:
Patient dissatisfaction
History of allergy or gastrointestinal intolerance to methylene blue
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using online websites so that each block contains 6 patients.
The generated sequence will be placed in sealed, opaque and numbered envelopes.
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 Mashhad University of Medical Sciences
Street address
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Approval date
2021-09-14, 1400/06/23
Ethics committee reference number
IR.MUMS.REC.1400.171
Health conditions studied
1
Description of health condition studied
COVID 19 Disease
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
mortality
Timepoint
One month after entering the study
Method of measurement
Patient death
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group receive methylene blue in addition to conventional therapies (corticosteroids, anticoagulants, remdesivir, and antibiotics). Methylene blue is given to the patient in the form of a sachet to be dissolved in a glass of lukewarm water and drunk after one hour. The drug is prescribed every 8 hours on the first and second day and every 12 hours from the third day until discharge.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive only conventional therapies, including oxygen, corticosteroids, anticoagulants, Remdesivir and antibiotics.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Mohsen Seddigh-Shamsi
Street address
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3859 8818
Email
seddighshamsim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayour Mobarhan
Street address
Deputy of Research and Technology, Central University Building, next to Hoveyzeh Cinema, University Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@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
Dr Zahra-Sadat Sanei
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3859 8818
Email
zahrasanei93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Seddigh-Shamsi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3859 8818
Email
seddighshamsim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Seddigh-Shamsi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3859 8818
Email
seddighshamsim@mums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After collecting and analyzing the data, the results will be made available to the public in the form of articles.
When the data will become available and for how long
After the publication of the article
To whom data/document is available
physicians
Under which criteria data/document could be used
There are no restrictions
From where data/document is obtainable
Dr Mohsen Seddigh Shamsi, Mashhad University of Medical Science
What processes are involved for a request to access data/document