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

Mashhad University of Medical Sciences

Status and phase: Unknown; Phase 1

Conditions: Covid-19

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04370288

IR.MUMS.REC.1399.122

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Control group

No Intervention group

Description:

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

Intervention group

Experimental group

Description:

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

Treatment:

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