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Evaluation of the effectiveness of PHR-160 spray in hospitalized COVID-19 patients with severe lung involvement in improving oxygen saturation; a randomized clinical trial study

Protocol summary

Study aim
The effectiveness of phr-160 spray in improving the respiratory status of Covid-19 patients in the emergency department
Design
Clinical trial with control group, parallel groups, randomized, phase 1 on 240 patients. Excel software rand function was used for randomization
Settings and conduct
This multicenter study is in coordination with Baqiyatallah Hospital / Martyrs of Tajrish Hospital / Khorshid Hospital of Isfahan. After confirming the patient's pulmonary involvement in favor of Covid-19 with CT scan and obtaining informed consent from the patient and checking the inclusion / exclusion criteria, they enter the study.
Participants/Inclusion and exclusion criteria
Inclusion creteria: Both sexes, Ages 15-75, Oxygen saturation percentage between 88 and 93% Confirmation of 19 patients by RT-PCR, Confirmation of Covid-19 using CT scan, Signing a informed consent form ٍExclusion creteria: Both sexes, Ages 15-75, Oxygen saturation percentage between 88 and 93%. Confirmation of 19 patients using RTPCR. Confirmation of Covid-19 using CT scan, Signing a informed consent form
Intervention groups
Treatment group: Inhalation of PHR-160 spray one puff per hour with Damiar during 6 hours after randomization in emergency depatment + standard emergency treatment Control group: Standard emergency treatment based on protocol Naproxen 250 mg, one tablet Famotidine 40 mg, one tablet Vitamin C 500 mg, one tablet
Main outcome variables
Primary outcome: 1. Comparison of oxygen saturation percentage in two intervention groups after randomization 2. Mean changes in oxygen saturation percentage after the intervention compared to oxygen saturation percentage at the beginning of the patient's entry into two intervention groups

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201223049816N1
Registration date: 2021-01-11, 1399/10/22
Registration timing: registered_while_recruiting

Last update: 2021-01-11, 1399/10/22
Update count: 0
Registration date
2021-01-11, 1399/10/22
Registrant information
Name
Fahimeh Shahjoei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 0067
Email address
fshahjooei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2021-03-17, 1399/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of PHR-160 spray in hospitalized COVID-19 patients with severe lung involvement in improving oxygen saturation; a randomized clinical trial study
Public title
Evaluation of the effectiveness of PHR-160 spray in hospitalized patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both sexes Ages 15-75 Oxygen saturation percentage between 88 and 93%. Confirmation of 19 patients using RTPCR. Confirmation of Covid-19 using CT scan Signing a informed consent form
Exclusion criteria:
Attending another trial in the last three months pregnancy/lactation drug sensitivity to the ingredients in the intervention very high severity of the disease in the emergency room (consciousness less than 15 / oxygen concentration less than 88%, etc) history of chronic respiratory disease Previous pulmonary embolism (last three months)
Age
From 15 years old to 75 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Data collection and data management will be done using electronic patient report forms and electronic data management system, and the steps of data cleaning and locking and data monitoring will be done on-line during the study.This set of forms is required for the initial assessment of the patient and the necessary examinations to determine the presence of COVID-19 disease and a checklist of exclusion and inclusion conditions. If patients are eligible to enter the study , they will enter the randomization stage and start the intervention. It is necessary to have this separate form set to prepare a Participant flow table according to the consort reporting standard.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah Hospital, Mollasadra Ave., Vanak Square ., Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2020-12-14, 1399/09/24
Ethics committee reference number
IR.BMSU.REC.1399.495

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
Percentage of oxygen saturation in two intervention groups after randomization
Timepoint
1. After randomization at the beginning of the patient's arrival, and every day
Method of measurement
Using Pulse Oximeter

Secondary outcomes

1

Description
The time required to reduce at least one grade of disease severity according to the Covid-19 national guideline
Timepoint
Every day
Method of measurement
Data collection and data management will be done using electronic patient report forms and electronic data management system, and the steps of data cleaning and locking and data monitoring will be done on-line during the study.

2

Description
Number and percentage of patients with adverse events and number and percentage of total adverse events
Timepoint
Evry day
Method of measurement
Data collection and data management will be done using electronic patient report forms and electronic data management system, and the steps of data cleaning and locking and data monitoring will be done on-line during the study.

Intervention groups

1

Description
Intervention group: 1. Phr-160 spray group: PHR spray:160 micrograms per puff, 1 puff every 1 hour up to ten times a day, on days 1 to 10 (use of Damir is required) in addition to the latest covid-19 treatment in the country protocol. Due to the clinical symptoms, this treatment protocol can be continued for 10 days if needed.
Category
Treatment - Drugs

2

Description
Control group: Standard emergency treatment based on protocol, Naproxen 250 mg , Famotidine 40 mg , Vitamin C 500 mg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences
Full name of responsible person
Fahime Shahjoei
Street address
Baqiyatallah university of Medical science, Mollasadra Ave., Vanak Square ., Tehran-
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8860 1624
Email
fshahjooie@yahoo.com

2

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Amir Hossein Ghazale
Street address
NO. 19899 34148, Shahrdari St., Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 8860 0067
Email
a.h.ghazale@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mostafa Ghanei
Street address
Baqiyatallah university of Medical science, Mollasadra Ave., Vanak Square ., Tehran
City
Tehran
Province
Tehran
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 21 8860 0067
Email
mghaneister@gmail.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
30
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 Hassan Saadat
Position
Assistanc professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Baqiyatallah university of Medical science, Mollasadra Ave., Vanak Square ., Tehran
City
Tehran
Province
Tehran
Postal code
۷۳۴۶۱-۸۱۷۴۶.
Phone
+98 21 8860 0067
Email
saadat350@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali asghar Akhlahghi
Position
Specialist, non-faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
District 6, Por Sina aVE., Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
6446-14155
Phone
+98 21 8860 0067
Email
akhlaghi90@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Amir Hosein Ghazale
Position
پزشک
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Baqiyatallah university of Medical science, Mollasadra Ave., Vanak Square ., Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8860 1624
Email
a.h.ghazale@gmail.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
Yes - There is 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
Title and more details about the data/document
Data can potentially be shared after people are not identifiable, but some data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
The access period will start 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of data will be allowed with the permission of the authors and obtaining written consent
From where data/document is obtainable
Dr. Fahimeh Shahjoui in Baqiyatallah Hospital.
What processes are involved for a request to access data/document
At the request of the applicant, the principal of the project can provide the license to the applicant within 3 months.
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