Protocol summary
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Study aim
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Evaluation of methylene blue administration on mortality of patients with acute respiratory distress syndrome caused by Covid disease 19
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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One-month mortality rate
General information
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Reason for update
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The sample size reduction from 87 to 65 participants in each group was done after the approval of the ethics committee of the university.
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Acronym
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IRCT registration information
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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
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Registration date
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2021-11-29, 1400/09/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-09-16, 1400/06/25
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Expected recruitment end date
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2022-03-16, 1400/12/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of methylene blue on acute respiratory distress syndrome in Covid-19 disease
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Public title
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The effect of methylene blue on acute respiratory distress syndrome in Covid-19 disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
130
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-09-14, 1400/06/23
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Ethics committee reference number
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IR.MUMS.REC.1400.171
Health conditions studied
1
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Description of health condition studied
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COVID 19 Disease
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ICD-10 code
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B34.2
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ICD-10 code description
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Coronavirus infection, unspecified
Primary outcomes
1
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Description
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mortality
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Timepoint
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One month after entering the study
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Method of measurement
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Patient death
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients in this group receive only conventional therapies, including oxygen, corticosteroids, anticoagulants, Remdesivir and antibiotics.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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After collecting and analyzing the data, the results will be made available to the public in the form of articles.
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When the data will become available and for how long
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After the publication of the article
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To whom data/document is available
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physicians
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Under which criteria data/document could be used
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There are no restrictions
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From where data/document is obtainable
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Dr Mohsen Seddigh Shamsi, Mashhad University of Medical Science
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What processes are involved for a request to access data/document
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Refer to the project supervisor
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Comments
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