The aim of this study is to investigate the effect of methylene blue along with vitamin C and N-acetyl cysteine in the treatment of COVID 19 patients
Design
A randomized, controlled trial, based on patients with Covid-19, which has two parallel groups.
Settings and conduct
Imam Reza Hospital
confirmed case of Covid-19 by RT-PCR on the nasopharyngeal swab collected or clinical and HR-CT features
Treatment with methylene blue (1 mg/kg) along with vitamin C 250 (mg/daily) and N-acetyl cysteine 2 gr/daily
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Confirmed case of Covid-19 (by RT-PCR, HRCT)
Admission to the intensive care unit
Need for intubation and mechanical ventilation (PaO2/FiO2 < 100-200)
Written informed consent
Exclusion criteria:
Age less than 18 years old
Pregnancy
History of renal diseases, heart diseases
Cirrhosis, active chronic hepatitis
The history of G6PDH deficiency
Severe renal failure
Intervention groups
Covid-19 patients treated with standard medical therapy (supportive therapy).
Covid-19 patients treated with mixture of MCN (Methylene blue, vitamin C, N-acetyl cysteine).
Main outcome variables
The respiratory rate-
The oxygen saturation -
The hospital stay-
The mortality rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191228045924N1
Registration date:2020-09-20, 1399/06/30
Registration timing:retrospective
Last update:2020-09-20, 1399/06/30
Update count:0
Registration date
2020-09-20, 1399/06/30
Registrant information
Name
Daryoush Hamidi Alamdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8574
Email address
hamidiad@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-19, 1399/01/31
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of methylene blue administration for treatment of COVID-19 patients
Public title
Effect of methylene blue on treatment of COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed case of Covid-19 (by RT-PCR, HRCT)
Admission to intensive care unit
Need for intubation and mechanical ventilation (PaO2/FiO2 < 100-200)
Written informed consent
Exclusion criteria:
Pregnancy and breastfeeding
G6PDH deficiency
Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
Active chronic hepatitis
Severe hepatic disease defined by GOT or GPT levels three times above the normal upper limit
Patients with history of allergic reaction or significant sensitivity to methylene blue
Treatment with immunosuppressive agents
Use of other investigational drugs in the moment of inclusion
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization, randomization unit: individual, randomization tool: by using the website of randomization: https://www.random.org/lists/
Simple randomization is done by random numbers generated by the randomization site, according to the list produced, individuals will be randomly assigned to the intervention (methylene blue) or control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
www.clinicaltrial.gov
Secondary trial Id
NCT04370288
Registration date
2020-04-30, 1399/02/11
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.MUMS.REC.1399.122
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, Treatment
Primary outcomes
1
Description
Saturated pressure oxygen (SPO2)
Timepoint
Third day, fifth day, tenth day
Method of measurement
Pulse micrometre
2
Description
Respiratory rate in one minute
Timepoint
Third day, fifth day, tenth day
Method of measurement
Physical exam
Secondary outcomes
1
Description
Mortality rate in both groups
Timepoint
Day 28
Method of measurement
Review of medical records
2
Description
Hospital stay
Timepoint
At the beginning of the study and the end of the trial
Method of measurement
Number of days
Intervention groups
1
Description
Intervention group: Covid-19 patients treated with methylene blue, vitamin C, N-acetyl cysteine. Treatment with methylene blue (60mg/daily) along with vitamin C 250 (mg/daily) and N-acetyl cysteine 2 gr/daily. These drugs are used for 7 days until 14 days. Methylene blue will be prepared by Omid Rajabi pharmaceutical company, Mashhad. Vitamin C will be prepared by Jalinous pharmaceutical company, Tehran. N-acetylcysteine will be prepared by Osve pharmaceutical company, Tehran.
Category
Treatment - Drugs
2
Description
Control group: Covid-19 patients treated with standard medical therapy (supportive therapy). Standard medical therapy is done for patients according to the Health Ministry instruction which WHO sends for the Health Ministry.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Daryoush Hamidi Alamdari
Street address
Iman Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3882 8574
Email
hamidiad@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3882 3255
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
Daryoush Hamidi Alamdari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Iman Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3882 8574
Email
hamidiad@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Daryoush Hamidi Alamdari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Iman Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3882 8574
Email
hamidiad@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Yarahmadi
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Iman Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9189511111
Phone
+98 51 3882 8574
Email
yarahmadiA961@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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data related to the project after unidentifiable of people will be shared.
When the data will become available and for how long
Access to data are allowed 6 months after the publication of results.
To whom data/document is available
Our data will be available for university staffs and academic institutions.
Under which criteria data/document could be used
All types of analysis for data are allowed by authorized researchers.
From where data/document is obtainable
hamidiad@mums.ac.ir
What processes are involved for a request to access data/document
Accept permission from the project implementer for the applicant