Application of Methylene Blue Along with Complementary Materials for Treatment of COVID-19 Outpatients with Less Than 8 Days from First Day of Clinical Symptoms
The determination of the effect of methylene blue along with complementary materials in decreasing the symptoms of disease, hospitalization and mortality in COVID-19 outpatients who referred to pulmonary clinic
Design
A randomized, controlled trial, based on outpatients with Covid-19, which has two parallel groups.
Settings and conduct
Covid-19 patients with positive PCR or HRCT who refer to the lung clinic and treatment with methylene blue (1 mg/kg/day) along with complementary materials
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Outpatients with COVID-19 referred to a lung clinic confirmed by HRCT or PCR.
SPO2 is between 70-96 after taking off the mask.
Age over 18 years old.
Exclusion Criteria:
Pregnancy
Severe impairment of liver and heart
Renal insufficiency including severe renal impairment
G6PD enzyme deficiency
Intervention groups
Covid-19 outpatients treated with standard medical therapy (supportive therapy) and methylene blue along with complementary materials
Application of Methylene Blue Along with Complementary Materials for Treatment of COVID-19 Outpatients with Less Than 8 Days from First Day of Clinical Symptoms
Public title
Investigation of Methylene Blue for treatment of COVID-19 outpatients referred to pulmonary clinic.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Outpatient COVID-19 patients who confirmed by PCR or HRCT referred to pulmonary clinic
SPO2 is between 70-96 after taking off the mask
Exclusion criteria:
Pregnancy
Severe impairment of liver and heart
Renal insufficiency including severe renal impairment
G6PD enzyme deficiency
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
240
Actual sample size reached:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization, randomization unit: individual, randomization tool: by using the website of randomization: https://www.random.org/lists/
Simple randomization is done by random numbers generated by the randomization site, according to the list produced, individuals will be randomly assigned to the intervention (methylene blue) or control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single blind, the evaluator, who is a health care professional (nurse) and is responsible for collecting data (symptoms and hospitalization and mortality) from patients after using the drug, is not aware that each patient belongs to control group or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2021-11-06, 1400/08/15
Ethics committee reference number
IR.MUMS.REC.1400.243
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
COVID-19,
ICD-10 code description
U07.1
Primary outcomes
1
Description
Oxygen pressure saturation
Timepoint
Interval time: the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue
Method of measurement
Pulse oximeter
2
Description
Respiratory Rate
Timepoint
Interval time: the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue
Method of measurement
Physical exam
3
Description
Headache
Timepoint
Interval time: the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue
Method of measurement
Physical exam
4
Description
Cough
Timepoint
Interval time: the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue
Method of measurement
Physical exam
5
Description
Shivery
Timepoint
Interval time: the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue
Method of measurement
Physical exam
6
Description
Chest pain
Timepoint
Interval time: the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue
Method of measurement
Physical exam
7
Description
Vomiting
Timepoint
Interval time: the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue
Method of measurement
Physical exam
8
Description
Diarrhea
Timepoint
Interval time: the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue
Method of measurement
Physical exam
9
Description
Fever
Timepoint
Interval time: the third day, the sixth day, the eleventh day, the fourteenth day after using Methylene Blue
Method of measurement
Physical exam
Secondary outcomes
1
Description
Hospital stay time
Timepoint
After 15 days
Method of measurement
Number of days
2
Description
Mortality rate
Timepoint
After 30 days
Method of measurement
Review of medical records
Intervention groups
1
Description
Intervention group: In addition to the standard treatment, Covid-19 outpatients are received orally methylene blue along with complementary materials two times per day in interval time 12 hours. The drug is used for 7 days until 14 days. Drug is prepared by Omid Rajabi pharmaceutical company. Methylene Blue (1 mg/Kg), Vitamin C, Glucose or sugar, Vitamine B1, B2, B3, Calcium Phosphate, Citrate Potassium, Carbonate Sodium, Glycine Amino Acid, Ginger, Lecithin, Ascorbyl Palmitate, Magnesium Stearate will be prepared as powder (in one sacchet) and it will used orally after dissolving in water.
Category
Treatment - Drugs
2
Description
Control group: Patients will received just the standard treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pulmonary clinic- Dr Davod Ataran- Dr Saeid Hafizi
Full name of responsible person
Dr. Daryoush Hamidi Alamdari
Street address
Iman Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3882 8574
Email
hamidiad@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour Mobarhan
Street address
Iman Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3882 8574
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
ِDr. Daryoush Hamidi Alamdari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Iman Reza Hospital, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3882 8574
Email
hamidiad@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Daryoush Hamidi Alamdari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Azadi Square, Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3882 8574
Fax
Email
hamidiad@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
ِDr. Daryoush Hamidi Alamdari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Azadi Square, Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3882 8574
Fax
Email
hamidiad@mums.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