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

Phase 1

• Conditions: Covid-19
• Interventions: Drug: MCN (Methylene blue, vitamin C, N-acetyl cysteine)

• Registration Number: NCT04370288
• Lead Sponsor: Mashhad University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-19
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-04
• Primary Completion: 2020-09-20
• Study Completion: 2020-09-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of patients remaining free of need for mechanical ventilation in both groups	Day 7	All patient will be assess for changes in disease severity.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Imam Reza Hospital; 🇮🇷 Mashhad, Razavi Khorasan, Iran, Islamic Republic of