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

NCT ID: NCT04370288

Last Updated: 2020-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-19

Study Completion Date

2020-09-21

Brief Summary

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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.

Detailed Description

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Conditions

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Covid-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Other Intervention Names

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Leucomethylene Blue

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Daryoush Hamidi Alamdari

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daryoush Hamidi Alamdari, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Mashhad University of Medical Sciences, Mashhad, Iran

Locations

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Imam Reza Hospital

Mashhad, Razavi Khorasan Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Daryoush Hamidi Alamdari, Ph.D

Role: CONTACT

+98 51 3882 8574

Amir Yarahmadi, Ph.D

Role: CONTACT

+98 51 3882 8574

Facility Contacts

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Ahmad Bagheri Moghaddam, M.D

Role: primary

05138412081

References

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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.

Reference Type DERIVED
PMID: 34019535 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32828741 (View on PubMed)

Other Identifiers

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IR.MUMS.REC.1399.122

Identifier Type: -

Identifier Source: org_study_id

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