Clinical trial NCT04370288: Clinical Application of Methylene Blue for Treatment of Covid-19 Patients
Official title: The Clinical Trial of Application of Methylene Blue Vial for Treatment of Covid-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Covid-19
Keywords: Covid-19
Coronavirus
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients remaining free of need for mechanical ventilation in both groups
timeFrame: Day 7
Secondary outcomes:
measure: Mortality rate in both groups
timeFrame: Day 28
measure: Improvement in Pa02/Fi02 ratio in both groups
timeFrame: Day 2
measure: Duration of hospital stay in both group.
timeFrame: Day 28
measure: Duration of Intensive Care Unit stay in both groups
timeFrame: Day 28
measure: Days free of dialysis in both groups
timeFrame: Day 28
measure: C-reactive proteins
timeFrame: 3-5 Days
measure: WBC Count
timeFrame: 3-5 Days
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Imam Reza Hospital
state: Razavi Khorasan
Study officials:
affiliation: Mashhad University of Medical Sciences, Mashhad, Iran
name: Daryoush Hamidi Alamdari, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamidi-Alamdari D, Hafizi-Lotfabadi S, Bagheri-Moghaddam A, Safari H, Mozdourian M, Javidarabshahi Z, Peivandi-Yazdi A, Ali-Zeraati A, Sedaghat A, Poursadegh F, Barazandeh-Ahmadabadi F, Agheli-Rad M, Tavousi SM, Vojouhi S, Amini S, Amini M, Majid-Hosseini S, Tavanaee-Sani A, Ghiabi A, Nabavi-Mahalli S, Morovatdar N, Rajabi O, Koliakos G. METHYLENE BLUE FOR TREATMENT OF HOSPITALIZED COVID-19 PATIENTS: A RANDOMIZED, CONTROLLED, OPEN-LABEL CLINICAL TRIAL, PHASE 2. Rev Invest Clin. 2021;73(3):190-198. doi: 10.24875/RIC.21000028.
citation: Alamdari DH, Moghaddam AB, Amini S, Keramati MR, Zarmehri AM, Alamdari AH, Damsaz M, Banpour H, Yarahmadi A, Koliakos G. Application of methylene blue -vitamin C -N-acetyl cysteine for treatment of critically ill COVID-19 patients, report of a phase-I clinical trial. Eur J Pharmacol. 2020 Oct 15;885:173494. doi: 10.1016/j.ejphar.2020.173494. Epub 2020 Aug 20.