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Trial - IRCT20090701002113N2


Column Value
Trial registration number IRCT20090701002113N2
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Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Yunos Ghasemi

Contact
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

info@sums.ac.ir

Registration date
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2020-08-25

Recruitment status
Last imported at : Dec. 15, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Open label

Center
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

>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
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Number of arms
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Shiraz University of Medical Sciences

Inclusion age min
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Severe/critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

260

primary outcome
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Death

Notes
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 797, "treatment_name": "Methylene blue", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]