The investigation of the effectiveness of ASA usage on the incidence of cardiovascular events in patients with corona virus (COVID-19) A clinical trial study
Determining of the effectiveness of ASA usage on the incidence of cardiovascular events in patients with corona virus (COVID-19) in Rasht in 2020.
Design
Clinical trial with control group, with parallel groups, single blind, randomized, phase 2 on 36 patients. Random permutation block method will be used to assign treatment to the subjects. Therefore, considering that group A is patients who are taking aspirin 80 mg and group B is the group who are not taking aspirin 80 mg. The complete randomization file is available as an Excel file (randomization is done with SAS software version 9
Settings and conduct
Patients diagnosed with Covid 19 are randomly divided into two groups receiving aspirin 80 mg for three months and the group not receiving aspirin. Demographic and clinical information is then obtained from the patient by the physician. Patients in the intervention group will be followed up for six months (during these three months as well as three months later). This research will be single blind. Patients and data analysts and researchers evaluate blind outcome.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients admitted to Razi Hospital over 18 years of age based on CT scan or PCR diagnosis of COVID 19
Exclusion criteria: patients admitted to the ICU, Patients with a history of ulcers and gastrointestinal problems, patients receiving aspirin, patients with a history of thrombotic events such as heart attack or stroke or a history of atrial fibrillation, congestive heart failure, active bleeding or coagulation disorders such as thrombocytopenia.
Intervention groups
Patients are randomly divided into two intervention groups receiving aspirin and the control group not receiving aspirin.
Main outcome variables
Incidence of cardiovascular events
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038626N7
Registration date:2020-12-27, 1399/10/07
Registration timing:registered_while_recruiting
Last update:2020-12-27, 1399/10/07
Update count:0
Registration date
2020-12-27, 1399/10/07
Registrant information
Name
Zahra Ahmadnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
zahmadnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-04-04, 1400/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of the effectiveness of ASA usage on the incidence of cardiovascular events in patients with corona virus (COVID-19) A clinical trial study
Public title
The investigation of the effectiveness of ASA usage on corona virus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients admitted with a diagnosis of Covid 19 based on CT scan or PCR
Over 18 years
Exclusion criteria:
patients admitted to the ICU.
Patients with a history of ulcers and gastrointestinal problems.
Patients receiving aspirin.
patients with a history of thrombotic events such as heart attack or stroke or a history of atrial fibrillation, congestive heart failure, active bleeding or coagulation disorders such as thrombocytopenia.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In order to allocate treatment to the subjects, randomized permutation block method and considering six hex blocks, 6 blocks will be produced for 36 patients. Therefore, considering that group A is patients who are taking aspirin 80 mg and group B is the group who are not taking aspirin 80 mg. The complete randomization file is available as an Excel file (randomization is done with SAS software version 9).
Blinding (investigator's opinion)
Single blinded
Blinding description
The two groups studied can be divided into two letters (A group receiving aspirin) and B (group not receiving drugs) in the form of a sealed envelope to the evaluating researcher, and at the end the envelope will be opened and it will be determined that What are the treatments A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Rasht, Namjoo Ave., Shahid Siadati St., Faced to the 17th Shahrivar Hospital, Old Building, School of Health, University of Technology Research and Technology
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2020-11-09, 1399/08/19
Ethics committee reference number
IR.GUMS.REC.1399.372
Health conditions studied
1
Description of health condition studied
COVID-19 disease
ICD-10 code
U07. 1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Thromboembolic events
Timepoint
Thromboembolic events at the beginning of the study and 3 and 6 months later
Method of measurement
Clinical signs and laboratory tests
2
Description
Cardiovascular accidents
Timepoint
Cardiovascular accidents at the beginning of the study and 3 and 6 months later
Method of measurement
Electrocardiography, Echocardiography
3
Description
Brain accidents
Timepoint
Brain accidents at the beginning of the study and 3 and 6 months later
Method of measurement
CT scan
Secondary outcomes
1
Description
Death
Timepoint
6 months later
Method of measurement
Phone call with the patient
Intervention groups
1
Description
Intervention group: Patients with covid 19 were treated daily with aspirin 80 mg for three months.
Category
Treatment - Drugs
2
Description
Control group: Patients with covid19 received standard treatment for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital, Rasht
Full name of responsible person
Zahra ahmadnia
Street address
Razi Educational and Medical Center, Sardar Jangal St
City
Rasht
Province
Guilan
Postal code
41448
Phone
+98 13 3354 1001
Email
razi.hospital@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
Namjoo Ave., Shahid Siadati St., Rasht., Technology & Research Vice-chancellor of University
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 5821
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Zahra ahmadnia
Position
Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
gums.icrc@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra ahmadnia
Position
Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
gums.icrc@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra ahmadnia
Position
پرستاری
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
gums.icrc@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Request to receive unidentifiable personal data or other documents
From where data/document is obtainable
Dr, Elham Ramezanzadeh
What processes are involved for a request to access data/document