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

Protocol summary

Study aim
To evaluate the effect of intravenous methylene blue on the clinical course and outcomes of patients with COVID-19 infections
Design
This is a parallel design, single center, phase 3, concealed randomized clinical trial study which will be conducted on 260 patients. Patients will be randomized into two groups using an online program available from https://www.sealedenvelope.com/simple-randomiser/v1/lists.
Settings and conduct
This study will be conducted in the Shiraz Transplant Center, Abu Ali Sina Hospital, Shiraz, Iran. Patient will have 24-hour heart monitoring. In order to minimize any bias between groups as a general policy, all patients will only receive lopinavir/retonavir (Kaletra®) as their treatment regimen for COVID-19.
Participants/Inclusion and exclusion criteria
inclusion criteria: 1. >18 yrs old 2. PCR confirmation of COVID-19 3. Severe or critical diseases as: RR>30 breaths/second, SpO2<94% on room air sea level, lung infiltration of >50%, PaO2/FiO2 <300 mmHg and/or any individual with respiratory failure, septic shock, and/or multiple organ dysfunction exclusion criteria: 1. Pregnancy 2. G6PD deficiency 3. Severe renal failure (defined as GFR<30 mL/min/1.3m2) 4. History of allergic reaction to drug 5. Patients on serotonergic psychiatric drugs (including SSRIs, SNRIs, TCAs, MAOIs), dapsone and different hydroxylamine 6. Organ transplantation recipients 7. Not consenting to enter study
Intervention groups
Intervention group: Kaletra and corticosteroid and methylene blue. Control group: Kaletra and corticosteroid.
Main outcome variables
Death; partial pressure of oxygen/Fraction of inspired oxygen ; Length of intensive care unit stay; In-hospital complications rates; white blood cell count/leukopenia; C-reactive protein levels

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090701002113N2
Registration date: 2020-08-25, 1399/06/04
Registration timing: registered_while_recruiting

Last update: 2020-08-25, 1399/06/04
Update count: 0
Registration date
2020-08-25, 1399/06/04
Registrant information
Name
Jamshid Roozbeh
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 6400
Email address
roozbehj@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-15, 1399/05/25
Expected recruitment end date
2020-12-15, 1399/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Methylene Blue for the Treatment of COVID-19: A Randomized Clinical Trial
Public title
Methylene Blue in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 260
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2020-04-05, 1399/01/17
Ethics committee reference number
IR.SUMS.REC.1399.016

Health conditions studied

1

Description of health condition studied
COVID-19 infection
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Death
Timepoint
2 weeks after intervention
Method of measurement
follow-up visit

Secondary outcomes

1

Description
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

2

Description
Length of hospital stay
Timepoint
Daily until discharge
Method of measurement
Daily follow-up visitation

3

Description
ICU admission rate
Timepoint
ِDaily until the end of hospitalization
Method of measurement
Daily follow-up visitation

4

Description
In-hospital complications rates
Timepoint
Daily until the end of hospitalization
Method of measurement
Daily follow-up visitation

5

Description
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

6

Description
C-reactive protein levels
Timepoint
first day of hospital admission, and 1, 3, and 5 days after administration
Method of measurement
By blood test

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Abu Ali Sina Hospital
Full name of responsible person
Siavash Gholami
Street address
Sadra street
City
Shiraz
Province
Fars
Postal code
71994-67985
Phone
+98 71 3334 4000
Fax
+98 71 3643 0038
Email
abualisinacharity@gmail.com
Web page address
https://abualisina.net/%d8%aa%d9%85%d8%a7%d8%b3-%d8%a8%d8%a7-%d9%85%d8%a7/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yunos Ghasemi
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5401
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Roozbeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Faghihi Hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 1235 6400
Fax
+98 71 1234 9336
Email
roozbehj@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Roozbeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Faghihi Hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 1235 6400
Fax
+98 71 1234 9336
Email
roozbehj@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Roozbeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Faghihi Hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 1235 6400
Fax
+98 71 1234 9336
Email
roozbehj@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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