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

NCT04370288 | Unknown Phase 1

• 1 other identifier: IR.MUMS.REC.1399.122
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19

Keywords

Covid-19; Coronavirus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Control group

NO INTERVENTION

Covid-19 patients treated with standard medical therapy (supportive therapy).

Intervention group

EXPERIMENTAL

Covid-19 patients treated with mixture of MCN (Methylene blue, vitamin C, N-acetyl cysteine).

Drug: MCN (Methylene blue, vitamin C, N-acetyl cysteine)

Interventions

MCN (Methylene blue, vitamin C, N-acetyl cysteine) DRUG

A mixture of MCN will be injected to covid-19 patients.

Also known as: Leucomethylene Blue

Intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Imam Reza Hospital

Mashhad, Razavi Khorasan Province, 9137913316, Iran

RECRUITING

Related Publications (2)

• 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.

  PMID: 34019535 DERIVED

• 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.

  PMID: 32828741 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Methylene Blue; Ascorbic Acid; Acetylcysteine; hydromethylthionine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; Cysteine; Amino Acids, Sulfur; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Daryoush Hamidi Alamdari, Ph.D

  Mashhad University of Medical Sciences, Mashhad, Iran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daryoush Hamidi Alamdari, Ph.D

CONTACT

+98 51 3882 8574; hamidiad@mums.ac.ir

Amir Yarahmadi, Ph.D

CONTACT

+98 51 3882 8574; yarahmadiA961@mums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: April 30, 2020
• Study Start: April 19, 2020
• Primary Completion: September 20, 2020
• Study Completion: September 21, 2020
• Last Updated: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

IR (1)