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Clinical Application of Methylene Blue for Treatment of Covid-19 Patients (Covid-19)

Primary Purpose

Covid-19

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
MCN (Methylene blue, vitamin C, N-acetyl cysteine)
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring Covid-19, Coronavirus

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Confirmed case of Covid-19 (by RT-PCR, HRCT)
  2. Admission to Intensive Care Unit
  3. Need for intubation and mechanical ventilation (PaO2/FiO2 < 100-200)
  4. Written informed consent

Exclusion Criteria:

  1. Pregnancy and breastfeeding
  2. History of G6PDH deficiency
  3. Preadmission anticoagulation
  4. Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
  5. Medical records of cirrhosis
  6. Active chronic hepatitis
  7. Severe hepatic disease defined by GOT or GPT levels three times above the normal upper limit
  8. Patients with history of allergic reaction or significant sensitivity to Methylene blue
  9. Treatment with immunosuppressive agents
  10. Use of other investigational drugs in the moment of inclusion

Sites / Locations

  • Imam Reza HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

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).

Outcomes

Primary Outcome Measures

Proportion of patients remaining free of need for mechanical ventilation in both groups
All patient will be assess for changes in disease severity.

Secondary Outcome Measures

Mortality rate in both groups
Improvement in Pa02/Fi02 ratio in both groups
Duration of hospital stay in both group.
Duration of Intensive Care Unit stay in both groups
Days free of dialysis in both groups
C-reactive proteins
WBC Count

Full Information

First Posted
April 29, 2020
Last Updated
April 30, 2020
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04370288
Brief Title
Clinical Application of Methylene Blue for Treatment of Covid-19 Patients
Acronym
Covid-19
Official Title
The Clinical Trial of Application of Methylene Blue Vial for Treatment of Covid-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 19, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Anticipated)
Study Completion Date
September 21, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The severe acute respiratory syndrome caused by COVID-19 is now a global catastrophic event. Currently there is no approved drug or vaccine for the disease. Methylene blue (MB, oxidized form, blue color) has been used in many different areas of clinical medicine, ranging from malaria to orthopedics. Leucomethylene Blue (reduced form of MB, colorless) may be applied for the treatment of COVID-19 according to the scientific evidences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
Covid-19, Coronavirus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Covid-19 patients treated with standard medical therapy (supportive therapy).
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Covid-19 patients treated with mixture of MCN (Methylene blue, vitamin C, N-acetyl cysteine).
Intervention Type
Drug
Intervention Name(s)
MCN (Methylene blue, vitamin C, N-acetyl cysteine)
Other Intervention Name(s)
Leucomethylene Blue
Intervention Description
A mixture of MCN will be injected to covid-19 patients.
Primary Outcome Measure Information:
Title
Proportion of patients remaining free of need for mechanical ventilation in both groups
Description
All patient will be assess for changes in disease severity.
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Mortality rate in both groups
Time Frame
Day 28
Title
Improvement in Pa02/Fi02 ratio in both groups
Time Frame
Day 2
Title
Duration of hospital stay in both group.
Time Frame
Day 28
Title
Duration of Intensive Care Unit stay in both groups
Time Frame
Day 28
Title
Days free of dialysis in both groups
Time Frame
Day 28
Title
C-reactive proteins
Time Frame
3-5 Days
Title
WBC Count
Time Frame
3-5 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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 History of G6PDH deficiency Preadmission anticoagulation Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2) Medical records of cirrhosis 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daryoush Hamidi Alamdari, Ph.D
Phone
+98 51 3882 8574
Email
hamidiad@mums.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Yarahmadi, Ph.D
Phone
+98 51 3882 8574
Email
yarahmadiA961@mums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daryoush Hamidi Alamdari, Ph.D
Organizational Affiliation
Mashhad University of Medical Sciences, Mashhad, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imam Reza Hospital
City
Mashhad
State/Province
Razavi Khorasan
ZIP/Postal Code
9137913316
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Bagheri Moghaddam, M.D
Phone
05138412081
Email
bagheria@mums.ac.ir

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
34019535
Citation
Hamidi-Alamdari D, Hafizi-Lotfabadi S, Bagheri-Moghaddam A, Safari H, Mozdourian M, Javidarabshahi Z, Peivandi-Yazdi A, Ali-Zeraati A, Sedaghat A, Poursadegh F, Barazandeh-Ahmadabadi F, Agheli-Rad M, Tavousi SM, Vojouhi S, Amini S, Amini M, Majid-Hosseini S, Tavanaee-Sani A, Ghiabi A, Nabavi-Mahalli S, Morovatdar N, Rajabi O, Koliakos G. METHYLENE BLUE FOR TREATMENT OF HOSPITALIZED COVID-19 PATIENTS: A RANDOMIZED, CONTROLLED, OPEN-LABEL CLINICAL TRIAL, PHASE 2. Rev Invest Clin. 2021;73(3):190-198. doi: 10.24875/RIC.21000028.
Results Reference
derived
PubMed Identifier
32828741
Citation
Alamdari DH, Moghaddam AB, Amini S, Keramati MR, Zarmehri AM, Alamdari AH, Damsaz M, Banpour H, Yarahmadi A, Koliakos G. Application of methylene blue -vitamin C -N-acetyl cysteine for treatment of critically ill COVID-19 patients, report of a phase-I clinical trial. Eur J Pharmacol. 2020 Oct 15;885:173494. doi: 10.1016/j.ejphar.2020.173494. Epub 2020 Aug 20.
Results Reference
derived

Learn more about this trial

Clinical Application of Methylene Blue for Treatment of Covid-19 Patients

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