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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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21 April 2020 |
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Main ID: |
IRCT20200325046860N1 |
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Date of registration:
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2020-03-30 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Convalescent Plasma therapy for COVID-19 Patients
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Scientific title:
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Evaluation of Convalescent Plasma as a Potential Therapy for COVID-19 infected patients |
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Date of first enrolment:
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2020-03-15 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://en.irct.ir/trial/46759 |
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Study type:
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interventional |
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Study design:
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Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: Since convalescent plasma therapy in patients with COVID-19 disease has been approved by FDA as a investigational modality and being used in some other countries such as China and due to lack of curative medicine for the disease, this project will be performed in Iran as treatment for the patients.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Hassan Abolghasemi
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Address:
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Baqiyatallah University of Medical Sciences, Molla Sadra Ave ,Tehran,Iran
1435915371
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 81261 |
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Email:
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h.abolghasemi.ha@gmail.com |
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Affiliation:
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Bagheiat-allah University of Medical Sciences |
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Name:
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Hassan Abolghasemi
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Address:
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Baqiyatallah University of Medical Sciences, Molla Sadra Ave
1435915371
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 81261 |
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Email:
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h.abolghasemi.ha@gmail.com |
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Affiliation:
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Bagheiat-allah University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: COVID-19 infected patients with moderate to severe symptoms
COVID-19 infected patients with severe symptoms non responding to other treatments
Exclusion criteria: NO confirmed COVID-19 Disease
Age minimum:
no limit
Age maximum:
no limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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COVID-19 Disease.
COVID-19 Disease
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U07.02
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Intervention(s)
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Intervention 1: Treatment group: Patients with confirmed COVID-19 infection who in addition to their current treatment will be infused with 500 Ml convalescent plasma in 4 hrs. Intervention 2: Control group: Patients hospitalized with COVID-19 disease who are receive routine treatment.
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Primary Outcome(s)
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Improving Respiratory function of patients. Timepoint: Every 24 hours. Method of measurement: Clinical and, Para-clinical.
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Source(s) of Monetary Support
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Darmanara .Co
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Iran Blood Transfusion Organization
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Ethics review
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Status: Approved
Approval date: 09/03/2020
Contact:
Ethical Committee of Higher Education and Research Institute of Blood Transfusion Medicine
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Status: Approved
Approval date: 14/03/2020
Contact:
Medical Ethics Committee of Baqiyatallah University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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