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The Evaluation of effectiveness of heparin nebulizer in reduction of respiratory distress in patients with COVID-19

Protocol summary

Study aim
The Evaluation of effectiveness of heparin nebulizer in reduction of respiratory distress in patients with COVID-19
Design
This study is a one-blind randomized clinical trial, without control group, with 2 intervention parallel groups and phase 2-3, in which 64 patients are randomly divided into 2 groups of 30 using a random number table.
Settings and conduct
main outcome variables will be studied before the intervention. Patients will be intervened for three days and after three days the main outcome variables in the two groups will be re-evaluated and the results will be recorded in the two groups. And will be compared. This study is performed in Shohada Kargar and Shahid Sadoughi hospitals in Yazd.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with COVID-19 treated in Yazd in the summer of 1400 with lung involvement proven on radiography and with respiratory distress. Patients treated with anticoagulants, patients with Types of coagulation disorders, Patients with proven cardiovascular disease, Patients taking medications that interfere with the medications we are using.
Intervention groups
total of 60 patients selected by simple random sampling using a random number table will be divided into two groups of 30: intervention and placebo. Then, 60 questionnaires were prepared in advance, 30 of which were written in group A and the other 30 in group B. Is provided to the patient and The patient is asked to choose one of them blindly. If he chooses A, he will receive a 5,000-unit heparin nebulizer every 8 hours, and if he chooses B, he will be given the same amount of normal saline.
Main outcome variables
Respiratory rate, severity of lung involvement on radiograph, percentage of arterial blood oxygen saturation, patient body temperature and severity of shortness of breath

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210513051275N1
Registration date: 2021-07-06, 1400/04/15
Registration timing: prospective

Last update: 2021-07-06, 1400/04/15
Update count: 0
Registration date
2021-07-06, 1400/04/15
Registrant information
Name
Maryam Tavakoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3825 4040
Email address
m.tavakoli@iayazd.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of effectiveness of heparin nebulizer in reduction of respiratory distress in patients with COVID-19
Public title
The Evaluation of effectiveness of heparin nebulizer in reduction of respiratory distress in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with COVID-19 treated in Yazd In the Summer of 2021, which was proven by radiographic involvement in radiography andThey have respiratory distress and O2 SAT below 90%.
Exclusion criteria:
Patients treated with anticoagulants Patients with a variety of coagulation disorders Patients who have impaired coagulation tests at initial evaluation. Patients with proven cardiovascular disease Patients taking medications that interfere with the medications we use. Patients with severe COVID-19 who require ICU admission and mechanical ventilation prior to intervention. Patients who do not have clear lung involvement on radiography and respiratory distress.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
60 patients selected by simple random sampling and Using a table of random numbers, they will be divided into two groups of 30 intervention and placebo. Then, 60 questionnaires were prepared in advance, on 30 of which were group A and It is written on the other 30 numbers of group B. It is given to the patient and the patient is asked to choose one of them blindly. If he chooses A, he will receive a heparin nebulizer and If B is selected, the same amount of normal saline will be nebulized for it.
Blinding (investigator's opinion)
Single blinded
Blinding description
En Only patients are unaware of how to group and the amount and type of medication used It is necessary to mention in this research the drugs used and Their levels in both experimental groups are completely routine and tested
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran Islamic Azad University of Medical Sciences
Street address
No: 403, Corner of Gol Yakh St., Aineh Blvd., Amir Paberja St., Gholhak Intersection, Dr.Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2021-04-10, 1400/01/21
Ethics committee reference number
IR.IAU.PS.REC.1400.002

Health conditions studied

1

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

Primary outcomes

1

Description
Number of breaths
Timepoint
Before the intervention and three days after the start of the intervention
Method of measurement
Cardiac device for monitoring and recording information in a questionnaire

2

Description
Percentage of arterial blood oxygen saturation (SpO2)
Timepoint
Before the intervention and three days after the start of the intervention
Method of measurement
Pulse oximetry of cardiac monitoring device and recording information in a questionnaire

3

Description
Patient body temperature
Timepoint
Before the intervention and three days after the start of the intervention
Method of measurement
Digital thermometer (forehead temperature measurement)

4

Description
Severity of lung involvement
Timepoint
Before the intervention and three days after the start of the intervention
Method of measurement
Radiographic device

5

Description
Severe shortness of breath
Timepoint
Before the intervention and three days after the start of the intervention
Method of measurement
Patient self-declaration

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They will be treated with a heparin nebulizer at a dose of 5,000 units every 8 hours
Category
Treatment - Drugs

2

Description
Intervention group: They will be treated with normal saline (placebo) at a dose of 5,000 units every 8 hours
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd
Full name of responsible person
ِDr. Maryam Tvakoli
Street address
Ibn Sina Street, Shahid Ghandi Boulevard, Safaieh
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
sadoghi-hospital@ssu.ac.ir
Web page address
https://web.ssu.ac.ir

2

Recruitment center
Name of recruitment center
Yazd Shohada Kargar Hospital
Full name of responsible person
ِDr. Maryam Tvakoli
Street address
Prayer Square, Modares Bolvd
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3182 2000
Fax
+98 35 3825 0007
Email
shohadakargar.hos@tamin.ir
Web page address
https://shohadakargar.tamin.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Seyed Mohammadreza Mortazavi Zade
Street address
Boulevard of the Shohadaie Gomnam, Safaieh
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3187 2200
Fax
+98 35 3821 5034
Email
info@iauyazd.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
ِDr.Maryam Tavakoli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Shohada kargar hospital, Modares blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3825 4040
Fax
+98 35 3825 0007
Email
shohadakargar.hos@tamin.ir
Web page address
https://shohadakargar.tamin.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
ِDr.Maryam Tavakoli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Shohada kargar hospital, Modares blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3825 4040
Fax
+98 35 3825 0007
Email
shohadakargar.hos@tamin.ir
Web page address
https://shohadakargar.tamin.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
ِDr.Maryam Tavakoli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Shohada kargar hospital, Modares blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3825 4040
Fax
+98 35 3825 0007
Email
shohadakargar.hos@tamin.ir
Web page address
https://shohadakargar.tamin.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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