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IRCT20191228045924N1 IRCT 2020-09-20 Mashhad University of Medical Sciences Effect of methylene blue on treatment of COVID-19 patients Evaluation of the efficacy and safety of methylene blue administration for treatment of COVID-19 patients 2020-04-19 anticipated 80 Complete https://irct.ir/trial/49767 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple randomization, randomization unit: individual, randomization tool: by using the website of randomization: https://www.random.org/lists/ Simple randomization is done by random numbers generated by the randomization site, according to the list produced, individuals will be randomly assigned to the intervention (methylene blue) or control groups. 3 Covid-19. Intervention 1: Intervention group: Covid-19 patients treated with methylene blue, vitamin C, N-acetyl cysteine. Treatment with methylene blue (60mg/daily) along with vitamin C 250 (mg/daily) and N-acetyl cysteine 2 gr/daily. These drugs are used for 7 days until 14 days. Methylene blue will be prepared by Omid Rajabi pharmaceutical company, Mashhad. Vitamin C will be prepared by Jalinous pharmaceutical company, Tehran. N-acetylcysteine will be prepared by Osve pharmaceutical company, Tehran. Intervention 2: Control group: Covid-19 patients treated with standard medical therapy (supportive therapy). Standard medical therapy is done for patients according to the Health Ministry instruction which WHO sends for the Health Ministry. Yes - There is a plan to make this available What will be shared: All data related to the project after unidentifiable of people will be shared. When: Access to data are allowed 6 months after the publication of results. To whom: Our data will be available for university staffs and academic institutions. Conditions: All types of analysis for data are allowed by authorized researchers. Where to obtain: hamidiad@mums.ac.ir How to obtain: Accept permission from the project implementer for the applicant Comments:
public Daryoush Hamidi Alamdari
Iman Reza Hospital, Daneshgah Ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3882 8574 hamidiad@mums.ac.ir Mashhad University of Medical Sciences scientific Daryoush Hamidi Alamdari
Iman Reza Hospital, Daneshgah Ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3882 8574 hamidiad@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 18 years 90 years Both Pregnancy and breastfeeding G6PDH deficiency Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2) 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 U07.1 COVID-19, Treatment Treatment - Drugs Treatment - Other Intervention group: Covid-19 patients treated with methylene blue, vitamin C, N-acetyl cysteine. Treatment with methylene blue (60mg/daily) along with vitamin C 250 (mg/daily) and N-acetyl cysteine 2 gr/daily. These drugs are used for 7 days until 14 days. Methylene blue will be prepared by Omid Rajabi pharmaceutical company, Mashhad. Vitamin C will be prepared by Jalinous pharmaceutical company, Tehran. N-acetylcysteine will be prepared by Osve pharmaceutical company, Tehran. Control group: Covid-19 patients treated with standard medical therapy (supportive therapy). Standard medical therapy is done for patients according to the Health Ministry instruction which WHO sends for the Health Ministry. Saturated pressure oxygen (SPO2). Timepoint: Third day, fifth day, tenth day. Method of measurement: Pulse micrometre. Respiratory rate in one minute. Timepoint: Third day, fifth day, tenth day. Method of measurement: Physical exam. Mortality rate in both groups. Timepoint: Day 28. Method of measurement: Review of medical records. Hospital stay. Timepoint: At the beginning of the study and the end of the trial. Method of measurement: Number of days. NCT04370288 www.clinicaltrial.gov Mashhad University of Medical Sciences Approved 2020-04-19 Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Daneshgah Ave Mashhad Razavi Khorasan Iran (Islamic Republic of)