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

Covid-19 Clinical Trial

— Covid-19  

Official title:

The Clinical Trial of Application of Methylene Blue Vial for Treatment of Covid-19 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04370288
• Other study ID #: IR.MUMS.REC.1399.122
• Status: Recruiting
• Phase: Phase 1
• Start date: April 19, 2020
• Est. completion date: September 21, 2020

Study information

• Verified date: April 2020
• Source: Mashhad University of Medical Sciences
• Contact: Daryoush Hamidi Alamdari, Ph.D
• Phone: +98 51 3882 8574
• Email: hamidiad[@]mums.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 21, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid-19

Intervention

Drug:
• MCN (Methylene blue, vitamin C, N-acetyl cysteine)
A mixture of MCN will be injected to covid-19 patients.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Reza Hospital	Mashhad	Razavi Khorasan

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality rate in both groups		Day 28
Secondary	Improvement in Pa02/Fi02 ratio in both groups		Day 2
Secondary	Duration of hospital stay in both group.		Day 28
Secondary	Duration of Intensive Care Unit stay in both groups		Day 28
Secondary	Days free of dialysis in both groups		Day 28
Secondary	C-reactive proteins		3-5 Days
Secondary	WBC Count		3-5 Days