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IRCT20200409047007N2 IRCT 2021-11-29 Mashhad University of Medical Sciences The effect of methylene blue on acute respiratory distress syndrome in Covid-19 disease The effect of methylene blue on acute respiratory distress syndrome in Covid-19 disease 2021-09-16 anticipated 130 Complete https://irct.ir/trial/59923 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is done using online websites so that each block contains 6 patients. The generated sequence will be placed in sealed, opaque and numbered envelopes. 3 COVID 19 Disease. Intervention 1: Intervention group: Patients in this group receive methylene blue in addition to conventional therapies (corticosteroids, anticoagulants, remdesivir, and antibiotics). Methylene blue is given to the patient in the form of a sachet to be dissolved in a glass of lukewarm water and drunk after one hour. The drug is prescribed every 8 hours on the first and second day and every 12 hours from the third day until discharge. Intervention 2: Control group: Patients in this group receive only conventional therapies, including oxygen, corticosteroids, anticoagulants, Remdesivir and antibiotics. Yes - There is a plan to make this available What will be shared: After collecting and analyzing the data, the results will be made available to the public in the form of articles. When: After the publication of the article To whom: physicians Conditions: There are no restrictions Where to obtain: Dr Mohsen Seddigh Shamsi, Mashhad University of Medical Science How to obtain: Refer to the project supervisor Comments:
public Dr Zahra-Sadat Sanei
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3859 8818 zahrasanei93@gmail.com Mashhad University of Medical Sciences scientific Dr Mohsen Seddigh-Shamsi
Department of Internal Medicine, Imam Reza Hospital, Shariati Square
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3859 8818 seddighshamsim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The patient has received remdesivir and corticosteroids and antibiotics and anticoagulants At least one day and at most 5 days have passed since the patient's hospitalization. O2 saturation for 10 minutes without oxygen is less than 89 and more than 75 Age between 18 to 75 year Does not have a history of G6PD Deficiency Absence of chronic renal failure with GFR <30 Absence of heart failure with EF<40% Does not have COPD with CO2>45 The patient is not intubated Does not have systolic Blood Pressure <90 Do not take SSRI, MAO Inhibitor drugs Has not received plasma therapy, IVIG, hemoperfusion, Tocilizumab and plasmapheresis before administration of methylene blue Does not be pregnant The patient should be conscious 18 years 75 years Both Patient dissatisfaction History of allergy or gastrointestinal intolerance to methylene blue B34.2 Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group receive methylene blue in addition to conventional therapies (corticosteroids, anticoagulants, remdesivir, and antibiotics). Methylene blue is given to the patient in the form of a sachet to be dissolved in a glass of lukewarm water and drunk after one hour. The drug is prescribed every 8 hours on the first and second day and every 12 hours from the third day until discharge. Control group: Patients in this group receive only conventional therapies, including oxygen, corticosteroids, anticoagulants, Remdesivir and antibiotics. Mortality. Timepoint: One month after entering the study. Method of measurement: Patient death. Mashhad University of Medical Sciences Approved 2021-09-14 Ethics Committee of Mashhad University of Medical Sciences Department of Internal Medicine, Imam Reza Hospital, Shariati Square Mashhad Razavi Khorasan Iran (Islamic Republic of)