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CTRI Number  CTRI/2021/04/033142 [Registered on: 27/04/2021] Trial Registered Prospectively
Last Modified On: 26/04/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   To see how Methylene blue drug which is used to increase O2 saturation levels, is helpful in treating Covid 19 patients.  
Scientific Title of Study   An Observational pilot study to determine the effectiveness of Methylene Blue treatment in Covid 19 patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SMITHA K S 
Designation  Assistant professor 
Affiliation  Bangalore Medical College and Research Institute. 
Address  Department of Anesthesia Bangalore Medical College and Research Institute Fort K R Road Bangalore
406/A , I main, II cross, BSK III stage, Bangalore
Bangalore
KARNATAKA
560002
India 
Phone  9886935506  
Fax    
Email  smi9685@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SMITHA K S 
Designation  Assistant professor 
Affiliation  Bangalore Medical College and Research Institute. 
Address  Department of Anesthesia Bangalore Medical College and Research Institute Fort K R Road Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9886935506  
Fax    
Email  smi9685@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SMITHA K S 
Designation  Assistant professor 
Affiliation  Bangalore Medical College and Research Institute. 
Address  Department of Anesthesia Bangalore Medical College and Research Institute Fort K R Road Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9886935506  
Fax    
Email  smi9685@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute, Bangalore 
 
Primary Sponsor  
Name  DR SMITHA K S 
Address  406/A, I main, II cross, BSK III Stage, Bangalore 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Smitha K S  Bangalore Medical College and Research Institute  Department of Anaesthesia Fort K R Road Bangalore
Bangalore
KARNATAKA 		 9886935506

smi9685@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Medical College and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Methylene blue injection  1 mg/kg of Methylene blue injection given to covid 19 patients to treat Methemoglobinemia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1) Confirmed case of Covid 19 (RT-PCR)
2) Admission to Intensive care unit
3) Sex-Males and Females
4) Age- 18 to 90 years old.
5) Need for Oxygen support ( HFNC, NIV)
6) Respiratory rate (RR) between 20 to 30
7) SpO2 between ≤90 to 94 on room air.
8) PaO2/FiO2 <200-300
9) Written informed consent 
 
ExclusionCriteria 
Details  Pregnancy and breastfeeding
2) History of G6PD deficiency
3) Severe renal insufficiency (GFR<30ml/min/1.73m2)
4) Medical records of Cirrhosis
5) Active or Chronic Hepatitis
6) History of allergy to Methylene blue
7) Patients on immunosuppressive agents.
8) Patients exposed to aniline dyes and Dapsone 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To observe the effects of Methylene blue treatment in Covid 19 patients.  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
To record side effects of Methylene blue treatment in covid 19 patients  30 days 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/05/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not published yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [smi9685@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   As Covid pandemic has created a havoc through out the world with alarming morbidity and mortality. There are many treatment modalities at present for covid, one such being treatment with methylene blue. As it is seen that in covid patients there will be hypoxia due to methhemoglobinemia.  Methylene blue is FDA approved drug for the same.Hence , the main purpose of this study is to observe the effects of its treatment in covid patients. Also, this pilot study aims to help in generating a protocol for further randomised controlled studies in treatment of covid patients with Methylene blue. 
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