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

April 30, 2020 updated by: Daryoush Hamidi Alamdari, Mashhad University of Medical Sciences

The Clinical Trial of Application of Methylene Blue Vial for Treatment of Covid-19 Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Daryoush Hamidi Alamdari, Ph.D
  • Phone Number: +98 51 3882 8574
  • Email: hamidiad@mums.ac.ir

Study Contact Backup

Study Locations

  • Iran, Islamic Republic of
    • Razavi Khorasan
      • Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 9137913316
        • Recruiting
        • Imam Reza Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Covid-19 patients treated with standard medical therapy (supportive therapy).
Experimental: Intervention group
Covid-19 patients treated with mixture of MCN (Methylene blue, vitamin C, N-acetyl cysteine).
Drug: MCN (Methylene blue, vitamin C, N-acetyl cysteine)
A mixture of MCN will be injected to covid-19 patients.
Other Names:
  • Leucomethylene Blue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients remaining free of need for mechanical ventilation in both groups
Time Frame: Day 7
All patient will be assess for changes in disease severity.
Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality rate in both groups
Time Frame: Day 28
Day 28
Improvement in Pa02/Fi02 ratio in both groups
Time Frame: Day 2
Day 2
Duration of hospital stay in both group.
Time Frame: Day 28
Day 28
Duration of Intensive Care Unit stay in both groups
Time Frame: Day 28
Day 28
Days free of dialysis in both groups
Time Frame: Day 28
Day 28
C-reactive proteins
Time Frame: 3-5 Days
3-5 Days
WBC Count
Time Frame: 3-5 Days
3-5 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Principal Investigator: Daryoush Hamidi Alamdari, Ph.D, Mashhad University of Medical Sciences, Mashhad, Iran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2020

Primary Completion (Anticipated)

September 20, 2020

Study Completion (Anticipated)

September 21, 2020

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 4, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.MUMS.REC.1399.122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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