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Methylene Blue in COVID-19

Methylene Blue for the Treatment of COVID-19: A Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090701002113N2
Enrollment
260
Registered
2020-08-25
Start date
2020-08-15
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 infection. COVID-19, virus identified

Interventions

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 treatme

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: >18 yrs old PCR confirmation of COVID-19 Severe or critical diseases as: respiratory rate>30 breaths/second, oxygen saturation50%, 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

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

Design outcomes

Primary

MeasureTime frame
Death. Timepoint: 2 weeks after intervention. Method of measurement: follow-up visit.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJamshid Roozbeh

Shiraz University of Medical Sciences

roozbehj@sums.ac.ir+98 71 1235 6400

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026