Determining the effect of Pinen.Hydronoplacton.Ribonucleic acid (PHR) spray in reducing the length of hospital stay of patients with Covid-19
Design
A phase 2 clinical trial with control and intervention groups, with parallel, non-blind, randomized, groups on 188 patients. Clustering method was used for randomization
Settings and conduct
This study is a randomized clinical trial that will be performed in the Hospitals of Kashan University of Medical Sciences. Samples will be selected from patients with COVID-19 based on inclusion criteria and patients will be randomly divided into two groups including a control group and an intervention group.
Participants/Inclusion and exclusion criteria
Male or female patients aged 18 to 75 years with COVID-19 who have been diagnosed by PCR or clinical examination and lung scan; Informed consent by the patient or patient companion to participate in the study
Intervention groups
Intervention group: In addition to the routine treatment regimen, patients will receive 1 puff of PHR spray (160 micrograms per puff) every 1 hour to ten times a day on days 1 to 10.
The control group will receive the usual treatment in accordance with the national protocol.
Main outcome variables
Percentage of oxygen saturation, dyspnea, and severity of cough
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210222050457N1
Registration date:2021-04-20, 1400/01/31
Registration timing:registered_while_recruiting
Last update:2021-04-20, 1400/01/31
Update count:0
Registration date
2021-04-20, 1400/01/31
Registrant information
Name
Fatemeh Shirvanizade arani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5472 5800
Email address
dr.shirvanizade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-04, 1399/12/14
Expected recruitment end date
2021-05-04, 1400/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of Pinen.Hydronoplacton.Ribonucleic acid (PHR) spray on reducing the length of hospital stay of patients with Covid-19
Public title
Determining the effect of Pinen.Hydronoplacton.Ribonucleic acid (PHR) spray in reducing the length of hospital stay of patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female patients aged 18 to 75 years with COVID-19 who have been diagnosed with a lung scan, PCR, or clinical examination.
Obtaining informed consent from the patient or patient caregiver to participate in the study
Exclusion criteria:
Cancer patients undergoing chemotherapy
Patients with immunodeficiency diseases receiving immunomodulators
Patients with uncontrolled heart, kidney or liver failure
Women who are pregnant or breastfeeding
Patients with low level of consciousness who are not able to inhale the spray
Age
From 18 years old to 75 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
188
Randomization (investigator's opinion)
Randomized
Randomization description
First, the intervention and control groups were coded with the letter A and Bm respectively, and then randomization list will be prepared using the website www. sealedenvelope.com/simple-randomiser/v1/lists via selecting a sample size of 188 (two groups of 94) and permuted block randomization method (block size=4), (47 blocks of 4). Then, the subjects included in the study will be assigned to one of the two groups A or B through the obtained randomization list. For example, suppose that the permutation method is ABBA in the first four blocks, so the first and fourth samples will be assigned to group A and the second and third samples to group B, and the same will be continued until the last sample (188th person).
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 Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Qutb Ravandi Blvd., Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2021-02-19, 1399/12/01
Ethics committee reference number
IR.KAUMS.REC.1399.047
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
Percentage of arterial oxygen saturation
Timepoint
Before and after intervention on a daily basis
Method of measurement
Pulse oximeter
2
Description
Severity of cough
Timepoint
Before and after intervention on a daily basis
Method of measurement
Based on the degree of severity
3
Description
Shortness of breath
Timepoint
Before and after intervention on a daily basis
Method of measurement
Based on the degree of severity
Secondary outcomes
1
Description
Length of stay in hospital
Timepoint
By day
Method of measurement
Number of days
2
Description
ICU admision time
Timepoint
By day
Method of measurement
Number of days
Intervention groups
1
Description
Intervention group: In addition to the routine treatment regimen, patients will receive a puff of PHR spray 160 (6 micrograms per puff) using a spacer,10 times a day during10 days. PHR160 spray made by Jabr Ibn Hayan Pharmaceutical Company was used in this trial.
Category
Treatment - Drugs
2
Description
Control group: They will receive control of the usual treatment for the disease according to the normal treatment regimen of the hospital including one 250 mg naproxen tablet every 12 hours (for 5 days), 500 mg azithromycin on the first day, and 250 mg on the second to fifth days, 40 mg famotidine every 12 hours for 5 days, and 25 mg prednisolone daily for 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shahid Beheshti Hopspital
Full name of responsible person
Fatemeh Shirvanizadeh Arani
Street address
Shahid Beheshti hospital complex, Qotb –e Ravandi Blvd, km 5 of Ravand road, Kashan
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5472 5800
Email
dr.shirvanizade@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Shirvanizadeh Arani
Street address
Kashan University of Medical Sciences, Qotb –e Ravandi Blvd., Kashan
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5472 5800
Email
dr.shirvanizade@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
50
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
Kashan University of Medical Sciences
Full name of responsible person
Reza Razzaqi
Position
Physician
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Kashan University of Medical Sciences, Qotb –e Ravandi Blvd., Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5472 5800
Email
rrazzaghi33@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Aran O Bidgol Health Center
Full name of responsible person
Fatemeh Shirvani Arani
Position
Physician
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Health Center, Imam Khomeini Boulevard, Aran O Bidgol
City
Aran O Bidgol
Province
Isfehan
Postal code
8741646949
Phone
+98 31 5472 5800
Email
Dr.shirvanizade@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Afshar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, Qotb –e Ravandi Blvd., Kashan
City
Kashan
Province
Isfehan
Postal code
88141-87159
Phone
+98 31 5472 5800
Email
afshar_m_1344@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