Clinical Application of Methylene Blue for Treatment of Covid-19 Patients
NCT ID: NCT04370288
Last Updated: 2020-05-04
Study Results
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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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2020-04-19
2020-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
Covid-19 patients treated with standard medical therapy (supportive therapy).
No interventions assigned to this group
Intervention group
Covid-19 patients treated with mixture of MCN (Methylene blue, vitamin C, N-acetyl cysteine).
MCN (Methylene blue, vitamin C, N-acetyl cysteine)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Admission to Intensive Care Unit
3. Need for intubation and mechanical ventilation (PaO2/FiO2 \< 100-200)
4. Written informed consent
Exclusion Criteria
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
18 Years
90 Years
ALL
No
Sponsors
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Mashhad University of Medical Sciences
OTHER
Responsible Party
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Daryoush Hamidi Alamdari
Associate professor
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
Other Identifiers
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IR.MUMS.REC.1399.122
Identifier Type: -
Identifier Source: org_study_id
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