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 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.
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
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200727048217N1
Registration date:2020-09-13, 1399/06/23
Registration timing:registered_while_recruiting
Last update:2020-09-13, 1399/06/23
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
Recruitment complete
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
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
Shahroud university of medical science ethics committee
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
Mortality rate from Covid-19
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
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
Prevention
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.