Effect of oral Organosulfur Compounds as adjuvant therapy on patients Hospitalized with COVID-19: A phase III, multicenter and double-blind randomized placebo-controlled clinical trial
Due to the prevalence of COVID-19 and its mortality, we decided to investigate whether the use of this drug can be effective in reducing the burden and course of the disease due to its anti-inflammatory properties of organosulfur compounds.
Design
The multi-center clinical trial, with the control group, parallel groups, double-blind, randomized, phase 3 on 60 patients. Participants were grouped 1: 1 in the placebo or drug group.
Settings and conduct
The test was performed at the Persian Gulf Martyrs Hospital in Bushehr. Each drug package had its own code, and the code is registered in the system.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-70 years old; no pregnancy or lactation; the patient does not need a ventilator. Exclusion criteria: history of sensitivity to organosulfurs; history of allergies to garlic and onions; patient with a history of hypotension or gastrointestinal bleeding; low blood pressure of the patient at the beginning of the study (below 120/80); patients with immunodeficiency (undergoing chemotherapy, organ and bone marrow transplantation, and patients with autoimmune diseases); inability of the patient to swallow oral medication that is not embedded for any reason NGtube or other means of receiving.
Intervention groups
Intervention group: administration of the organosulfur derivative capsule (90 mg) three times a day for 5 days with standard treatment of COVID-19. Control group: placebo three times a day for 5 days with standard treatment of COVID-19.
Main outcome variables
Clinical signs; lymphocyte percentage; LDH and SpO2; CRP; CBC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210422051044N1
Registration date:2021-05-28, 1400/03/07
Registration timing:prospective
Last update:2021-05-28, 1400/03/07
Update count:0
Registration date
2021-05-28, 1400/03/07
Registrant information
Name
Mohamed Gholizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 4111 8334
Email address
gholizadeh7575@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral Organosulfur Compounds as adjuvant therapy on patients Hospitalized with COVID-19: A phase III, multicenter and double-blind randomized placebo-controlled clinical trial
Public title
Effect of Organosulfur Compounds on COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants age are within 18-70 years
Participants should not be pregnant or Breastfeeding
Participants who not ventilator dependence
Exclusion criteria:
History of allergy to Organosulfur Compounds
History of allergies to garlic and onions
The patient has a history of hypotension
The patient has a history of Gastrointestinal bleeding
hypotension at the beginning of the study (below 120/80)
The patient has a history immunodeficiency diseases
The inability of the patient to swallow the oral medication or via NG tube
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who will admit to Shohadaye-Khalij-e-Fars Hospital in Bushehr province will randomly assign in a 1:1 ratio. Control groups receive a placebo three times a day for 5 days. Other groups receive 90 mg tab of Organosulfur Compounds three times a day for 5 days.
Blinding (investigator's opinion)
Double blinded
Blinding description
For each pack of pills, there is a code recorded in the computer, and the drug or placebo is determined, and these codes are not disclosed until after the analysis of the results. The code of each pack which the patient will use will be recorded in the patient file and none of the patient, nurse, physician, or person analyzing the data know whether the relevant pill is a drug or a placebo.
Information of hospitalized patients through direct examination and information entered in the file and patients who are discharged are referred to the clinic on an outpatient basis on the tenth day.
Secondary outcomes
1
Description
Lymphocytopenia
Timepoint
Before starting the study, 10 days later
Method of measurement
Cell Counter (CBC)
Intervention groups
1
Description
Control group: Positive PCR patients referred to Bushehr Persian Gulf Hospital who received placebo
Category
Placebo
2
Description
Intervention group: PCR positive patients referred to Bushehr Persian Gulf Hospital who received a capsule of organosulfur compounds in a dose of 90 mg every 8 hours for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Khalij Fars Hospital (Bushehr University of Medical Sciences and Health Services)
Full name of responsible person
Katayoun Vahdat
Street address
Bushehr Province, Bushehr, Kuy-e-Bandar, Moallem St
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3332 3123
Email
k.vahdat@bpums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
NICOVIDEO Research Company
Full name of responsible person
Hossein Nik Tale
Street address
First floor, No. 92, Mulla Sadrap St., Dadgar St., Ahmadabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9176655158
Phone
+98 51 3841 1538
Fax
Email
hoseen.nikta@gmail.com
Web page address
http://coronanicovid.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
NICOVIDEO Research Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mohamed Gholizade
Position
Medical researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Morvarid camp, Bushehr Nuclear Power Plant, Boushehr
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 4111 8334
Fax
Email
gholizadeh7575@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Katayoun Vahdat
Position
Professor of Infectious Diseases
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Moallem St., Kuy-e-Bandar, Bushehr
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
0098 77 33254 1828
Fax
+98 77 3334 1827
Email
vahdatk@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mohamed Gholizade
Position
Medical researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Morvarid camp, Bushehr Nuclear Power Plant, Boushehr
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 4111 8334
Fax
Email
gholizadeh7575@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared with any applicant who has contacted the project manager after the publication of the article
When the data will become available and for how long
Access to data begins after the article is published
To whom data/document is available
The data is available to academics as well as people working in the industry
Under which criteria data/document could be used
Use of the data is unrestricted if the reference is mentioned
From where data/document is obtainable
With the numbers that are provided for them, they can also visit the clinics of Bohsher Medical Sciences in person.
What processes are involved for a request to access data/document
After contacting the project manager, the applicant will receive an answer within 3 working days