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

Conditions

Covid-19

Keywords

Covid-19, Coronavirus

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.

Taher A, Lashgari M, Sedighi L, Rahimi-Bashar F, Poorolajal J, Mehrpooya M.

2021-06-1037 citations

10.1007/s43440-021-00296-2

Methylene Blue for Treatment of Hospitalized COVID-19 Patients: A Randomized, Controlled, Open-Label Clinical Trial, Phase 2

Daryoush Hamidi-Alamdari, Saied Hafizi-Lotfabadi, Ahmad Bagheri Moghaddam, Hossin Safari, Mahnaz Mozdourian et al. (23 authors)

Revista de investigaci�n Cl�nica2021-05-0129 citations

10.24875/ric.21000028

Application of methylene blue -vitamin C -N-acetyl cysteine for treatment of critically ill COVID-19 patients, report of a phase-I clinical trial.

Alamdari DH, Moghaddam AB, Amini S, Keramati MR, Zarmehri AM, Alamdari AH, Damsaz M, Banpour H, Yarahmadi A, Koliakos G.

2020-08-2080 citations

10.1016/j.ejphar.2020.173494

Interventions

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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
Mortality rate in both groups	Day 28
C-reactive proteins	3-5 Days
WBC Count	3-5 Days
Days free of dialysis in both groups	Day 28

Countries

Iran

Contacts

Primary ContactDaryoush Hamidi Alamdari, Ph.D

hamidiad@mums.ac.ir+98 51 3882 8574

Backup ContactAmir Yarahmadi, Ph.D

yarahmadiA961@mums.ac.ir+98 51 3882 8574

Outcome results

None listed