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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04370288
Recruitment Status : Unknown
Verified April 2020 by Daryoush Hamidi Alamdari, Mashhad University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : April 30, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Daryoush Hamidi Alamdari, Mashhad University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid-19 Drug: MCN (Methylene blue, vitamin C, N-acetyl cysteine) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Trial of Application of Methylene Blue Vial for Treatment of Covid-19 Patients
Actual Study Start Date : April 19, 2020
Estimated Primary Completion Date : September 20, 2020
Estimated Study Completion Date : September 21, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Leucomethylene Blue


Outcome Measures
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Primary Outcome Measures :
  1. 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.


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370288


Contacts
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Contact: Daryoush Hamidi Alamdari, Ph.D +98 51 3882 8574 hamidiad@mums.ac.ir
Contact: Amir Yarahmadi, Ph.D +98 51 3882 8574 yarahmadiA961@mums.ac.ir

Locations
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Iran, Islamic Republic of
Imam Reza Hospital Recruiting
Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 9137913316
Contact: Ahmad Bagheri Moghaddam, M.D    05138412081    bagheria@mums.ac.ir   
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
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Principal Investigator: Daryoush Hamidi Alamdari, Ph.D Mashhad University of Medical Sciences, Mashhad, Iran
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daryoush Hamidi Alamdari, Associate professor, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04370288    
Other Study ID Numbers: IR.MUMS.REC.1399.122
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daryoush Hamidi Alamdari, Mashhad University of Medical Sciences:
Covid-19
Coronavirus
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Acetylcysteine
 N-monoacetylcystine
Methylene Blue
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antidotes
Enzyme Inhibitors