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

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: Covid-19
• Intervention / Treatment: Drug: MCN (Methylene blue, vitamin C, N-acetyl cysteine)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Razavi Khorasan
    • Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 9137913316
      • Recruiting
      • Imam Reza Hospital
      • Contact: Ahmad Bagheri Moghaddam, M.D; Phone Number: 05138412081; Email: bagheria@mums.ac.ir

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	All patient will be assess for changes in disease severity.	Day 7

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

General Publications

• 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.
• 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.

Study record dates

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: Covid-19; Coronavirus
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Protective Agents; Micronutrients; Respiratory System Agents; Vitamins; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine; Ascorbic Acid; Methylene Blue
• 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