Evaluation of the effect of Bosentan in the treatment of pulmonary pressure in patients with COVID-19 in Bu Ali Sina Hospital in Qazvin in 2021
Design
A double-blind randomized clinical trial study with a control group with a parallel design; on 60 patients. Block randomization method was used for randomization.
Settings and conduct
The study population is patients with COVID-19 admitted to Bouali sina Hospital in Qazvin in 2021 who has developed COVID-19 pneumonia and pulmonary hypertension. Blinding in this study is double blind that the drug and placebo are labeled by the manufacturer as "Group A" and "Group B". They are quite similar in appearance and the person participating in the study and the person distributing the medicine does not know about this labeling.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with COVID-19 referred to Bouali Hospital, Qazvin, in 2021, Patients with COVID-19 pneumonia and pulmonary hypertension
Exclusion criteria: age under 14 years, pregnant women, history of pulmonary hypertension, no severe obstructive pulmonary disease.
Intervention groups
The intervention group is patients with COVID-19 with pulmonary pressure that receive Bosentan 62.5mg twice a day for 10 days in addition to the drugs used in the treatment of COVID-19 (approved by the National Committee).
The control group is patients with COVID-19 with pulmonary pressure that receive only the drugs used in the treatment of COVID-19 (approved by the National Committee).
Main outcome variables
Pulmonary artery systolic pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210710051831N1
Registration date:2021-08-09, 1400/05/18
Registration timing:prospective
Last update:2021-08-09, 1400/05/18
Update count:0
Registration date
2021-08-09, 1400/05/18
Registrant information
Name
Fahimeh Shokrollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3378 5097
Email address
fahimeshokrollahi@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-12-23, 1400/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison assessment of Bosentan and routine medication on pulmonary hypertension among hospitalized patients with COVID-19
Public title
The effect of Bosentan in the treatment of pulmonary hypertension in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COVID-19 referred to Boali Sina hospital, Qazvin during 1400
patients with COVID-19 pneumonia and pulmonary hypertension
Willingness to participate in a research project
Signing the informed consent form
Exclusion criteria:
Age range under 14 years
Pregnant women
History of pulmonary hypertension
Severe obstructive pulmonary disease
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling is simple in that the names of all patients participating in the project is written and 60 people, which is equivalent to the sample size, will be selected by lot and through Permuted- Block randomization with blocks of size 8 (consisting of 4 participants in the intervention and 4 participants in the control groups) is used for random allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding in this study is double blind that the drug and placebo are labeled by the manufacturer as "Group A" and "Group B". They are quite similar in appearance and the person participating in the study and the person distributing the medicine does not know about this labeling.
the drug and placebo were labeled by the manufacturer Group A and Group B. Which are quite similar in appearance and the person participating in the study and the person distributing the medicine does not know about this labeling.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Boali Sina hospital, Boali Ave
City
Qazvin
Province
Qazvin
Postal code
3413786165
Approval date
2021-04-19, 1400/01/30
Ethics committee reference number
IR.QUMS.REC.1400.026
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified
2
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Pulmonary artery systolic pressure
Timepoint
Before and 10 days after the intervention
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The case group in addition to the drugs used in the treatment of COVID-19 (approved by the National Committee), is treated with Bosentan 62.5mg twice a day for 10 days.
Category
Treatment - Drugs
2
Description
Control group: Patients receive only the drugs used to treat COVID-19 (approved by the National Committee).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali Sina Hospital
Full name of responsible person
Fahimeh Shokrollahi
Street address
Boali Sina Hospital, Boali Sina Ave
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
fahimeshorollahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad mahdi Emamjomeh
Street address
Vice Chancellor of Research and Technology, Valiasr Street
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 7006
Email
memamjomeh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Fahimeh Shokrollahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Boali Sina Hospital, Boali Sina Ave
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
fahimeshorollahi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fahimeh Shokrollahi
Position
Reident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Boali Sina Hospital, Boali Sina Ave
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
fahimeshorollahi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fahimeh Shokrollahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Boali Sina Hospital, Boali Sina Ave
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
fahimeshokrollahi@ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD