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

Study Overview
=================
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.

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

Conditions
-----------------
Covid-19

Intervention / Treatment
-----------------
* Drug: MCN (Methylene blue, vitamin C, N-acetyl cysteine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed case of Covid-19 (by RT-PCR, HRCT) Admission to Intensive Care Unit Need for intubation and mechanical ventilation (PaO2/FiO2 < 100-200) Written informed consent Exclusion Criteria: Pregnancy and breastfeeding History of G6PDH deficiency Preadmission anticoagulation Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2) Medical records of cirrhosis Active chronic hepatitis Severe hepatic disease defined by GOT or GPT levels three times above the normal upper limit Patients with history of allergic reaction or significant sensitivity to Methylene blue Treatment with immunosuppressive agents Use of other investigational drugs in the moment of inclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Covid-19 patients treated with standard medical therapy (supportive therapy). | |
| Experimental: Intervention group<br>Covid-19 patients treated with mixture of MCN (Methylene blue, vitamin C, N-acetyl cysteine). | Drug: MCN (Methylene blue, vitamin C, N-acetyl cysteine)<br>* A mixture of MCN will be injected to covid-19 patients.<br>* Other names: Leucomethylene Blue;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19, Coronavirus