Evaluation of the effectiveness of PHR-160 spray in recovery of hospitalized patients with Covid-19 in Isfahan province in 1399
Design
Clinical trial with control group, with parallel groups, blind, randomized, phase 2 on 198 patients. RANDOM SAMPLING SPSS software was used for randomization.
Settings and conduct
Type of study
Randomized clinical trial, two parallel groups, blinded
Study community:
Patients hospitalized with Covid-19 with pulmonary involvement in Khorshid Hospital in Isfahan
Participants/Inclusion and exclusion criteria
Inclusion criteria
Age more than 18 years
Definite diagnosis of SARS-CoV-2 virus based on PCR
Diagnosis of pneumonia consistent with lung involvement with COVID-19 on CT scan
Criteria for non-entry
Having comorbidities (chronic kidney failure, cirrhosis, severe heart failure (less than 25% EF), active or untreated cancer)
Pregnancy and breastfeeding
Patients with hepatic enzymes including aspartate transaminase (AST) and alanine transaminase (ALT) at 5 times more than normal amount
Requirement to be admitted to the ICU at the beginning of hospitalization
Intervention groups
Intervention and control group:
1. Intervention group: PHR 160 spray, which contains 160 micrograms of active ingredient in each puff, 2 puffs every 2 hours during the awakening period using Damiar with national standard treatment
2. Control group: placebo spray containing proplant (HFA gas which is a carrier and inert) in double puff every 2 hours (except sleeping hours), along with the national standard treatment
Main outcome variables
• Duration and severity of symptoms (cough and shortness of breath)
• Duration of hospitalization
• Blood oxygen levels
• Requirement for ICU admission
• Duration of hospitalization in the ICU
• Death rate
General information
Reason for update
Acronym
ISF PHR-160 Study
IRCT registration information
IRCT registration number:IRCT20200411047029N1
Registration date:2021-04-24, 1400/02/04
Registration timing:registered_while_recruiting
Last update:2021-04-24, 1400/02/04
Update count:0
Registration date
2021-04-24, 1400/02/04
Registrant information
Name
Ramin Sami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2892
Email address
r.sami@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-05-21, 1400/02/31
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 recovery of hospitalized patients with Covid-19 in Isfahan province in 1399
Public title
Effectiveness of PHR-160 spray in recovery of hospitalized patients with Covid-19 in Isfahan province in 1399
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years
Definite diagnosis of SARS-CoV-2 virus based on PCR
Diagnosis of pneumonia consistent with lung involvement with COVID-19 on CT scan
Need to be admitted to the ICU at the beginning of hospitalization
Exclusion criteria:
Having comorbidities (chronic kidney failure, cirrhosis, severe heart failure (less than 25% EF), active or untreated cancer)
Pregnancy and breastfeeding
Patients with hepatic enzymes including aspartate transaminase (AST) and alanine transaminase (ALT) at 5 times more than normal amount
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
198
Randomization (investigator's opinion)
Randomized
Randomization description
If patients agree to participate, they will be placed in one of two intervention or control groups in the random allocation project using SPSS software. For this purpose, they are numbered from 1 to 198 in SPSS software. Then, using RANDOM SAMPLING, we select 50% of the samples and place the selected samples in the CASE group and the deleted samples in the control group.
Intervention and control group:
1. Intervention group: PHR 160 spray, which contains 160 micrograms of active ingredient in each puff, 2 puffs every 2 hours during the awakening period using Damiar with national standard treatment
2. Control group: placebo spray containing proplant (HFA gas which is a carrier and inert) in double puff every 2 hours (except sleeping hours), along with the national standard treatment
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding: Three-way blind
Blind groups in the study:
participant
research fellow
Analyzer
The study will be blinded in three ways. Patients will be blinded to the type of intervention, as well as the researcher who must enter the data into the relevant checklist, and the data analyzer will be blinded to the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine, Isfahan University of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-04-11, 1400/01/22
Ethics committee reference number
IR.MUI.MED.REC.1400.020
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
Duration and severity of symptoms (cough and shortness of breath)
Timepoint
Daily
Method of measurement
Case file-Query from patients
2
Description
Duration of hospitalization
Timepoint
Daily
Method of measurement
Case file
3
Description
Blood oxygen levels
Timepoint
Daily
Method of measurement
Pulse Oximeters
4
Description
Requirement for ICU admission
Timepoint
Daily
Method of measurement
Doctor diagnosis
5
Description
Duration of hospitalization in the ICU
Timepoint
Daily
Method of measurement
Case file
6
Description
Death rate
Timepoint
Daily
Method of measurement
Case file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: PHR 160 spray, which contains 160 micrograms of active ingredient in each puff, 2 puffs every 2 hours during the awakening period using Damiar with national standard treatment
Category
Treatment - Drugs
2
Description
Control group: Placebo spray containing proplant (HFA gas that is carrier and inert) in two puffs every 2 hours (except sleeping hours), along with the national standard treatment
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Ramin Sami
Street address
Sofe Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
2
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Dr. Ramin Sami
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2127
Email
nour@mui.ac.ir
Web page address
http://nour.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Research Institute of Food and Secrets TAAMASRAR
Full name of responsible person
hamidreza shekhroshandel
Street address
Unit 2, Corner of Hazrat Abolfazl St., Marzdaran Boulevard, Ashrafi Esfahani Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1461744366
Phone
+98 21 4425 4747
Email
info@taamasrar.com
Web page address
http://sibdiet.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Research Institute of Food and Secrets TAAMASRAR
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ramin Sami
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3222 2892
Email
r.sami@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ramin Sami
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hezaer Jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3222 2892
Email
r.sami@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ramin Sami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3222 2892
Email
r.sami@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After de-identifying the outcome data
When the data will become available and for how long
Six months after the article is published
To whom data/document is available
The data will only be available to researchers working at academic institutions.
Under which criteria data/document could be used
In order to spread the knowledge and with the permission of the research team
From where data/document is obtainable
The person responsible for updating the data
What processes are involved for a request to access data/document