Evaluation of thrombolytic and anticoagulant in treatment of COVID-19 patients
Design
This study is a randomized control trial with tree arm parallel group without double blind. We have three group, thrombolytic, UFH, and control. Randomization performed with Randlist software
Settings and conduct
This is a RCT of Tabriz, university of medical sciences. .The patients will be divided to three group. Two cases and control group. First will be started on tPA 25 mg over 2 hours and 22 mg next 22 hours. Second group on therapeutic dose of anticoagulation ( UFH with traumatic dose) and third group will be control with usual medications.
Participants/Inclusion and exclusion criteria
Critical COVID patients with d.Dimer more than 3000 ng/ml
Intervention groups
The patients will started on thrombolytic ( tPA) or UFH and third group will be as a control .
Main outcome variables
Some main outcome of this study are improve of oxygenasion, SOFA score and decrease of mortality
General information
Reason for update
Acronym
TACOVID
IRCT registration information
IRCT registration number:IRCT20200515047456N1
Registration date:2020-06-28, 1399/04/08
Registration timing:registered_while_recruiting
Last update:2020-06-28, 1399/04/08
Update count:0
Registration date
2020-06-28, 1399/04/08
Registrant information
Name
Farid Rashidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4901
Email address
fr2652@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-17, 1399/03/28
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Tissue Plasminogen Activator (tPA) in comparition of anticoagulation for treatment of critical COVID 19 patient
Public title
The role of anticoagulant and thrombolitic in treatment of COVID patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID patients with P/F ratio less than 100
D.dimer more than 3000 without response to other medications
Exclusion criteria:
Active bleeding
Platelet less than 30000
Without any contraindication for thrombolytic therapy
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by block method and Randlist software according to Seed schedule with 420059136 number
Blinding (investigator's opinion)
Single blinded
Blinding description
Only participants in this study were blinded, given that the patients are unconscious and under mechanical ventilation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Farid Rashidi, MD, Tuberculosis and Lung diseases research center, Imam Reza Hospital, Daneshgah St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2020-05-18, 1399/02/29
Ethics committee reference number
IR.TBZMED.REC.1399.127
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
Improve of oxygenasion
Timepoint
From first to 6th days of study
Method of measurement
Arterial blood gas
2
Description
Improve SOFA score
Timepoint
From first to 6th days of study
Method of measurement
Questionnaire
3
Description
Improve compliance
Timepoint
From first to 6th days of study
Method of measurement
Ventilator parameter
4
Description
decrease d.Dimer level
Timepoint
From first to 6th days of study
Method of measurement
Blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Without placebo
Category
Treatment - Drugs
2
Description
Intervention group: first intervention group, anticoagulant. ، the patients will be started on unfractional heparin. Blood sample will tale to keep PTT more than 50
Category
Treatment - Drugs
3
Description
Intervention group: second intervention group, thrombolytic ( tPA). The will be started 25 mg over 2 hours and 25 mg for next 22 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hostital
Full name of responsible person
Farid Rashidi, MD
Street address
Danrshgah
City
Tabriz
Province
Ardabil
Postal code
5166614756
Phone
+98 41 3336 4901
Email
fr2652@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farid Rashidi
Street address
Daneshgah
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 4901
Email
fr2652@yahoo.com
Grant name
Dr. Mohammad Samiea
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
10
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
Tabriz University of Medical Sciences
Full name of responsible person
Farid Rashidi
Position
Assistance professor of medicine
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Daneshgah
City
تبریز
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 4901
Email
fr2652@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farid Rashidi
Position
Assistance professor of medicine
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Daneshgah
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 0901
Email
fr2652@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farid Rshidi
Position
Assistance professor of medicine
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Daeshgah
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
0413364901
Email
fr2652@yahoo.com
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
Demographic information
When the data will become available and for how long
Six month after publication
To whom data/document is available
Researchers who work in university
Under which criteria data/document could be used
Only for information
From where data/document is obtainable
Via e.mail
What processes are involved for a request to access data/document