History
# Registration date Revision Id
2 2020-10-24, 1399/08/03 156234
1 2020-10-22, 1399/08/01 155724
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Investigating the efficacy and safety of herbal Myrtus inhalation spray in controlling the symptoms of patients with mild COVID-19
Design
This study is a single-center, prospective, randomized, open-labeled, controlled, parallel phase 3 clinical trial.
Settings and conduct
Outpatients with mild Qovid-19 referred to Baqiyatallah Hospital who are eligible for the study are randomly divided into intervention and control groups and are treated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age: equal or more than 18 years; The patient have written consciously and freely consent to participate in the study; The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19; Confirmed diagnosis of COVID-19, with RT-PCR confirmation; Less than 7 days have passed since the onset of symptoms. Exclusion criteria: History of allergy to this nasal spray ingredients; The patient is in another clinical trial at the same time; The patient needs to receive medical care from the inpatient care; Pregnancy; Lactation.
Intervention groups
Intervention group: Myrtus inhalation spray 1 puff every 12 hours, for 14 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Control group: routine treatment according to the latest national guideline for the treatment of new corona-virus
Main outcome variables
Clinical symptoms changes (dry cough, respiratory distress, fever)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080901001165N63
Registration date: 2020-10-22, 1399/08/01
Registration timing: retrospective

Last update: 2020-10-22, 1399/08/01
Update count: 1
Registration date
2020-10-22, 1399/08/01
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy and safety of herbal Myrtus inhalation spray in controlling the symptoms of patients with mild COVID-19
Public title
Investigating the efficacy and safety of Myrtus inhalation spray in controlling the symptoms of patients with mild COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: equal or more than 18 years; The patient have written consciously and freely consent to participate in the study; The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19. Confirmed diagnosis of COVID-19, with RT-PCR confirmation. Less than 7 days have passed since the onset of symptoms.
Exclusion criteria:
History of allergy to this nasal spray ingredients; The patient is in another clinical trial at the same time; The patient needs to receive medical care from the inpatient care; Pregnancy; Lactation.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method is used to randomized the patients. For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is a single-center, prospective, randomized, open-labeled, controlled, parallel phase 3 clinical trial.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Science
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.BMSU.REC.1399.159

Health conditions studied

1

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

Primary outcomes

1

Description
Clinical symptoms (dry cough)
Timepoint
Baseline (before the initiation of intervention), and day 7 from the initiation
Method of measurement
Physical examination,questionnaire

2

Description
Clinical symptoms (respiratory distress)
Timepoint
Baseline (before the initiation of intervention), and day 7 from the initiation.
Method of measurement
Pulse-oxymetery device

3

Description
Clinical symptoms (fever)
Timepoint
Baseline (before the initiation of intervention), and day 7 from the initiation
Method of measurement
Thermometer

Secondary outcomes

1

Description
Side effects
Timepoint
Before the intervention initiation (baseline) and day 7
Method of measurement
Physical examination

2

Description
Need to be hospitalized
Timepoint
Before the intervention initiation (baseline) and day 7
Method of measurement
Question from the patient

3

Description
Mortality
Timepoint
Day 28 from the initiation
Method of measurement
Clinical assessment

Intervention groups

1

Description
Intervention group: Myrtus inhalation spray 1 puff every 12 hours, for 14 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus)
Category
Treatment - Drugs

2

Description
Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Seyed Mohamad Javad Hosseini
Street address
Baqiyatallah hospital, Mollasadra St., Vanak Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
dr_mjhosseini@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholamhosein Alishiri =
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
R.bmsu@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Mohamad Javad Hosseini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
dr_mjhosseini@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Critical Care Pharmacotherapy
Street address
Baqiyatallah university of medical science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
yunespanahi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parisa Kianpour
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Pharmacotherapy
Street address
Pharmacy faculty, Tehran University of medical science, 16-Azar St., Enghelab Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4709
Email
parisa_kianpour@yahoo.com

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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