MedPath

Methylene Blue in COVID-19

Phase 3
Recruiting
Conditions
U07.1
COVID-19 infection.
COVID-19, virus identified
Registration Number
IRCT20090701002113N2
Lead Sponsor
Shiraz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
260
Inclusion Criteria

>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

Exclusion Criteria

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Death. Timepoint: 2 weeks after intervention. Method of measurement: follow-up visit.
Secondary Outcome Measures
NameTimeMethod
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.
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