Evaluation of the Effect of Methylene Blue with Supplements in the Treatment of Patients with Moderate to Severe Outpatient COVID-19 Infection in Comparison with the Control Group
Determining the effect of methylene blue with supplements on reducing the symptoms of hospitalization and mortality of patients with COVID virus 19 referred to the lung 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 are treated with methylene blue at standard dose / day (1mg /kg) and supplements
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Outpatients with COVID-19 virus referred to a Lung Clinic Confirmed by HRCT or PCR; SPO2 without Mask after Ten Minutes between 70-96; Age Over 18 Years Old. Exclusion Criteria: Pregnancy; Severe Liver and Heart Disease; Acute Renal Failure Associated with the Need for Dialysis; Glucose 6-Phosphate Dehydrogenase Deficiency.
Intervention groups
COVID-19 outpatients treated with standard medical therapy (supportive therapy) and methylene blue and supplements
Evaluation of the Effect of Methylene Blue with Supplements in the Treatment of Patients with Moderate to Severe Outpatient COVID-19 Infection in Comparison with the Control Group
Public title
Evaluation of the Effect of Methylene Blue in the Treatment of Outpatients with COVID-19 Referred to the Lung Clinic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Outpatients with COVID-19 virus referred to a Lung Clinic Confirmed by HRCT or PCR
SPO2 without Mask after Ten Minutes between 70-96
Age Over 18 Years Old
Exclusion criteria:
Pregnancy
Severe Liver and Heart Disease
Acute Renal Failure Associated with the Need for Dialysis
Glucose 6-Phosphate Dehydrogenase Deficiency
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
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 Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2022-02-26, 1400/12/07
Ethics committee reference number
IR.MUMS.REC.1400.344
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19
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
Intervention 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 Saeed Hafizi
Full name of responsible person
Dr Soroush Attaran
Street address
between 1st and 3rd Besat Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176756697
Phone
+98 51 3882 8574
Email
attarand@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 Avenue
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 Davood Attaran
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Qaem Hospital, Ahmadabad Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
91871 45785
Phone
+98 51 3833 2746
Email
attarand@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Davood Attaran
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Qaem Hospital, Ahmadabad Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
91871 45785
Phone
+98 51 3833 2746
Email
attarand@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Davood Attaran
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Qaem Hospital, Ahmadabad Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
91871 45785
Phone
+98 51 3833 2746
Email
attarand@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