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IRCT20090701002113N2 IRCT 2020-08-25 Shiraz University of Medical Sciences Methylene Blue in COVID-19 Methylene Blue for the Treatment of COVID-19: A Randomized Clinical Trial 2020-08-15 anticipated 260 Complete https://irct.ir/trial/50275 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation (case:control 1:1) will be done using the permuted block randomization method (block size of 4). The randomization sequence will be generated with an online program available from https://www.sealedenvelope.com/simple-randomiser/v1/lists. The generated random sequence will be inserted in an opaque envelop enumerated in sequence from 001 to 260, each of which will be used for consecutive study participants. 3 COVID-19 infection. Intervention 1: Intervention group: In order to minimize any bias between groups as a general policy, all patients will only receive lopinavir/retonavir (Kaletra®) and corticosteroids as their treatment regimen for COVID-19. Antibiotic medications use will be limited as much as possible and will only be used in each specific case based on the diagnosis of the infectious specialist or intensivist when necessary. On the second day of hospital admission, the intervention group will initially receive a single intravenous bolus of 1 mg/kg (1% solution) of methylene blue administered over 20-60 minutes. The patients will then be given 0.25 mg/kg per hour dose of methylene bluefor 24 hours. Methylene blue has a commercial name of METIBLO and generic name of Methylthioninium chloride . Each 1ml ampule contains 10 mg methylthionium chloride. It is made in Belgium by Oterop company. Intervention 2: Control group: These patients will only receive lopinavir/retonavir (Kaletra®) and corticosteroids as their treatment regimen for COVID-19. Antibiotic medications use will be limited as much as possible and will only be used in each specific case based on the diagnosis of the infectious disease specialist or emergency medicine specialist when necessary. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We have not yet decided on this.
public Jamshid Roozbeh
Shahid Faghihi Hospital
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 1235 6400 roozbehj@sums.ac.ir Shiraz University of Medical Sciences scientific Jamshid Roozbeh
Shahid Faghihi Hospital
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 1235 6400 roozbehj@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) >18 yrs old PCR confirmation of COVID-19 Severe or critical diseases as: respiratory rate>30 breaths/second, oxygen saturation<94% on room air sea level, lung infiltration of >50%, partial pressure of oxygen/Fraction of inspired oxygen <300 mmHg and/or any individual with respiratory failure, septic shock, and/or multiple organ dysfunction 18 years no limit Both Pregnancy G6PD deficiency Severe renal failure (defined as glomerular filtration rate<15 mL/min/1.3m2) History of allergic reaction to drug Patients on serotonergic psychiatric drugs (including selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake Inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors), dapsone and different hydroxylamine Organ transplantation recipients Not consenting to enter study U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: In order to minimize any bias between groups as a general policy, all patients will only receive lopinavir/retonavir (Kaletra®) and corticosteroids as their treatment regimen for COVID-19. Antibiotic medications use will be limited as much as possible and will only be used in each specific case based on the diagnosis of the infectious specialist or intensivist when necessary. On the second day of hospital admission, the intervention group will initially receive a single intravenous bolus of 1 mg/kg (1% solution) of methylene blue administered over 20-60 minutes. The patients will then be given 0.25 mg/kg per hour dose of methylene bluefor 24 hours. Methylene blue has a commercial name of METIBLO and generic name of Methylthioninium chloride . Each 1ml ampule contains 10 mg methylthionium chloride. It is made in Belgium by Oterop company. Control group: These patients will only receive lopinavir/retonavir (Kaletra®) and corticosteroids as their treatment regimen for COVID-19. Antibiotic medications use will be limited as much as possible and will only be used in each specific case based on the diagnosis of the infectious disease specialist or emergency medicine specialist when necessary. Death. Timepoint: 2 weeks after intervention. Method of measurement: follow-up visit. Partial pressure of oxygen/Fraction of inspired oxygen. Timepoint: first day of hospital admission, and 1, 3, and 5 days after administration. Method of measurement: By measuring arterial blood gas. Length of hospital stay. Timepoint: Daily until discharge. Method of measurement: Daily follow-up visitation. ICU admission rate. Timepoint: ِDaily until the end of hospitalization. Method of measurement: Daily follow-up visitation. In-hospital complications rates. Timepoint: Daily until the end of hospitalization. Method of measurement: Daily follow-up visitation. White blood cell count/leukopenia. Timepoint: first day of hospital admission, and 1, 3, and 5 days after administration. Method of measurement: By blood test. C-reactive protein levels. Timepoint: first day of hospital admission, and 1, 3, and 5 days after administration. Method of measurement: By blood test. Shiraz University of Medical Sciences Approved 2020-04-05 Ethics Committee of Shiraz University of Medical Sciences Zand Street Shiraz Fars Iran (Islamic Republic of)