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IRCT20200727048217N1 IRCT 2020-09-13 Shahroud University of Medical Sciences Effect of ethanol and DMSO in prophylaxis and treatment of COVID-19 Prophylaxis and treatment of COVID-19 using a nasal spray containing 3% dimethyl sulfoxide (DMSO) and 20% ethanol solution 2020-08-22 anticipated 610 Complete https://irct.ir/trial/49924 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 Covid-19. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: Primary and secendry outcomes When: 6 month after result publication To whom: Reserachers Conditions: for citation Where to obtain: SHMU Vice-Chancellor for Research and Technology - +982332396714 How to obtain: Send a requste form to SHMU Vice-Chancellor for Research and Technology Comments:
public Moslem Jafarisani
Hafte Tir SQ
Shahroud Iran (Islamic Republic of) ۳۶۱۴۷۷۳۹۵۵ +98 21 8670 5503 moslem.jafarisani@gmail.com Shahroud University of Medical Sciences scientific Moslem Jafarisani
Hafte Tir square
Shahroud Iran (Islamic Republic of) ۳۶۱۴۷۷۳۹۵۵ +98 23 3239 5054 moslem.jafarisani@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) COVID-19 Patients Close contact with COVID-19 Patinets No current and previous infection with COVID-19 (for the preventive phase) 20 years no limit Both immigrant patients pregnant patients Anxiety and obsessive-compulsive disorder Protocol noncompliance U07.1 U07.1 COVID-19, virus identified Treatment - Drugs Placebo Prevention 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. 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. 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. The mortality rate from Covid-19 patients. Timepoint: 2 weeks after intervention. Method of measurement: Survived or died according to the records. - Recovery rate from Covid-19. Timepoint: 2 weeks after intervention. Method of measurement: qRT-PCR. COVID-19 incidence in health employees. Timepoint: In intervention period. Method of measurement: qRT-PCR. General Health. Timepoint: At the start and the end of study. Method of measurement: Check list according to the Likert scale. O2 Saturation. Timepoint: Daily, 8,14 and 21 O'clock. Method of measurement: Pals Oxy-meter. Respiratory Rate. Timepoint: Daily, 8,14 and 21 O'clock. Method of measurement: Physical examination and berth count. Temperature. Timepoint: Daily, 8,14 and 21 O'clock. Method of measurement: Thermometer. Length of hospitalization. Timepoint: At the end of study. Method of measurement: Date of hospitalization and discharge stated in the patient file. 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. Time of separation from the ventilator. Timepoint: At the end of study. Method of measurement: Date stated in the patient file. Lymphocyte. Timepoint: At the beginning and end of the study. Method of measurement: Cell counter. Shahroud University of Medical Sciences Approved 2020-08-23 Ethics committee of Shahroud University of Medical Sciences Hafte-tire square Shahroud Semnan Iran (Islamic Republic of)