View older revisions Content changed at 2020-12-10, 1399/09/20

Protocol summary

Study aim
Effect of dimethyl sulfoxide (DMSO) and ethanol solution in the prevention of COVID-19 patients
Design
A clinical trial with a control group, with parallel groups, triple-blind, randomized, phase 3 on 440 patients. Excel software rand function was used for randomization.
Settings and conduct
This study will be performed on patients who are admitted to Imam Hossein hospital and health employees in Shahroud. Patients will randomly be allocated into two groups. The intervention group will receive dimethyl sulfoxide (DMSO) and ethanol solution inhalation spray and normal saline as a placebo for the control group respectively. This study performed as triple blinds.
Participants/Inclusion and exclusion criteria
-All outpatients with positive PCR tests with informed consent to participate in the study will be included. - Immigrants or those who are temporarily present in Shahroud, pregnant or lactating women, patients who develop an obsessive-compulsive disorder or anxiety due to interventions during the study, and non-compliance with the study protocol will be excluded. - Shahroud health employees
Intervention groups
The intervention group will receive dimethyl sulfoxide 3%(DMSO) inhalation spray and ethanol solution20%, and the control group will receive routine protocols and normal salin as placebo.
Main outcome variables
1. O2 Saturation (8, 14, 21) 2. Respiratory Rate (8, 14, 21) 3. Temperature (8, 14, 21) 4.Duration of hospital stay (at the end of the study) 5. Treatment outcome including recovery, ERDS, and duration of oxygen therapy (during the study period) 6. Need for intensive care and respiratory support (during the study period) 7. Time of separation from the device (during the study period) 8. Lymphocyte count (at the beginning of the study and during the study period) 9.Puls rate 10. COVID-19 incidence in prevention phase

General information

Reason for update
Addition in prevention phase
Acronym
IRCT registration information
IRCT registration number: IRCT20200727048217N1
Registration date: 2020-09-13, 1399/06/23
Registration timing: registered_while_recruiting

Last update: 2020-12-10, 1399/09/20
Update count: 1
Registration date
2020-09-13, 1399/06/23
Registrant information
Name
Moslem Jafarisani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
moslem.jafarisani@shmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylaxis and treatment of COVID-19 using a nasal spray containing 3% dimethyl sulfoxide (DMSO) and 20% ethanol solution
Public title
Effect of ethanol and DMSO in prophylaxis and treatment of COVID-19
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 Patients Close contact with COVID-19 Patinets No current and previous infection with COVID-19 (for the preventive phase)
Exclusion criteria:
immigrant patients pregnant patients Anxiety and obsessive-compulsive disorder Protocol noncompliance
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 610
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation in SPSS software will be done using random quadruple blocks. Because patients are gradually admitted to the study and to block the sample size in the two groups, the block method of volume 4 is used. For this purpose, 6 quadruple blocks will be created as follows 1-AABB 2- ABAB 3-ABBA 4-BBAA 5-BABA 6-BAAB Where A is for treatment 1 and B is for treatment 2. The random order will be such that first a random number will be created in Excel from 0 to 9. Depending on which block the random number belongs to, the sequence of that block will be used to assign patients to the control and intervention groups. For example, if the random number generated is 6, the first person will be assigned to group B, the second person to group A, the third person to group A, and the fourth person to group B. To reach the calculated sample size, the random number creation will be repeated 110 times. Because each time the task is assigned, four diseases are identified. It should be noted that if the random number is 7, 8, 9 and 0, it will be ignored.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study will be done in triple blinds. placebo will be used for blinding, which is prepared in packages similar to the main intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Hafte-tire square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2020-08-23, 1399/06/02
Ethics committee reference number
IR.SHMU.REC.1399.091

Health conditions studied

1

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

Primary outcomes

1

Description
The mortality rate from Covid-19 patients
Timepoint
2 weeks after intervention
Method of measurement
Survived or died according to the records

2

Description
- Recovery rate from Covid-19
Timepoint
2 weeks after intervention
Method of measurement
qRT-PCR

3

Description
COVID-19 incidence in health employees
Timepoint
In intervention period
Method of measurement
qRT-PCR

Secondary outcomes

1

Description
General Health
Timepoint
At the start and the end of study
Method of measurement
Check list according to the Likert scale

2

Description
O2 Saturation
Timepoint
Daily, 8,14 and 21 O'clock
Method of measurement
Pals Oxy-meter

3

Description
Respiratory Rate
Timepoint
Daily, 8,14 and 21 O'clock
Method of measurement
Physical examination and berth count

4

Description
Temperature
Timepoint
Daily, 8,14 and 21 O'clock
Method of measurement
Thermometer

5

Description
Length of hospitalization
Timepoint
At the end of study
Method of measurement
Date of hospitalization and discharge stated in the patient file

6

Description
The need for intensive care and respiratory support
Timepoint
At the end of study
Method of measurement
Date of transfer to the ICU and discharge stated in the patient file

7

Description
Time of separation from the ventilator
Timepoint
At the end of study
Method of measurement
Date stated in the patient file

8

Description
Lymphocyte
Timepoint
At the beginning and end of the study
Method of measurement
Cell counter

Intervention groups

1

Description
Intervention group: patients will receive nasal spray containing 20% ​​ethanol (German Merck), 3% dimethyl sulfoxide (German Merck) based on physiological serum. Three times a day (every 8 hours) a puff of spray will be applied to each nostril. The duration of use will be two weeks.
Category
Treatment - Drugs

2

Description
Control group: patients will use a spray containing normal saline (Razi Iran). Three times a day (every 8 hours) a puff spray will be applied to each nostril. The duration of use will be two weeks.
Category
Placebo

3

Description
Intervention group: employees will receive nasal spray containing 20% ​​ethanol (German Merck), 3% dimethyl sulfoxide (German Merck) based on physiological serum. Two times a day one puff of spray will be applied to each nostril. The duration of use will be 45 dayes.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Moslem Jafarisani
Street address
Hafte-Tir square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
moslem.jafarisani@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Emamian
Street address
7-e- Tir SQ
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۵۵
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
vcr@shmu.ac.ir
Web page address
http://shmu.ac.ir/research/fa/page/689/%D9%85%D8%B9%D8%A7%D9%88%D9%86-%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA-%D9%88-%D9%81%D9%86%D8%A7%D9%88%D8%B1%DB%8C
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Moslem Jafarisani
Position
Assiatant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Hafte Tir SQ
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۵۵
Phone
+98 21 8670 5503
Fax
+98 21 8670 5503
Email
moslem.jafarisani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Moslem Jafarisani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Hafte Tir square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۵۵
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
moslem.jafarisani@shmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Moslem Jafarisani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Hafte Tir square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۵۵
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
moslem.jafarisani@shmu.ac.ir

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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
Primary and secendry outcomes
When the data will become available and for how long
6 month after result publication
To whom data/document is available
Reserachers
Under which criteria data/document could be used
for citation
From where data/document is obtainable
SHMU Vice-Chancellor for Research and Technology - +982332396714
What processes are involved for a request to access data/document
Send a requste form to SHMU Vice-Chancellor for Research and Technology
Comments
Loading...