Evaluation of convalescent plasma therapy in the treatment of patients with COVID-19 disease
Design
Criteria of selection for plasma donors
1. The persons previously infected with COVID-19 and now recovered and discharged from hospitals
2. Donors should have normal laboratory tests according to guideline of Iran blood transfusion organization criteria
3. Voluntary consent to donate plasma
4. Maximum plasma volume of 650 ml
Selection criteria for plasma recipients
1. Blood oxygen saturation <90%
2. Abnormal lung CT scan
3. Significant shortness of breath
4- Fever
5. Not improving in the next 48 hours
6- There is no possibility of discharge in the next 48 hours
7- consent
Settings and conduct
1. Convalescent plasma will be received from those recovering from COVID-19 disease previously hospitalized at Baqiyatallah; Masih Daneshvari; hospitals in Tehran and Shahid Beheshti hospital in Qom.
2- Convalescent Plasma received from volunteers will be infused to the patients with confirmed infection of COVID-19.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Blood oxygenation saturation <90%
2. Abnormal lung CT scan
3. Significant shortness of breath
4. Fever
5. Not improving in the next 48 hours
6. There is no possibility of discharge of patient in the next 48 hours
7. Patient consent
Exclusion criteria
1. The patient should not be connected to a ventilator .
2. The patient has not given consent.
Intervention groups
Patients with confirmed COVID-19 disease
Main outcome variables
Reduction in all causes mortality; reduction of hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200325046860N1
Registration date:2020-03-30, 1399/01/11
Registration timing:registered_while_recruiting
Last update:2020-03-30, 1399/01/11
Update count:0
Registration date
2020-03-30, 1399/01/11
Registrant information
Name
Hassan Abolghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 3166
Email address
h.abolghasemi.ha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-15, 1398/12/25
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Convalescent Plasma as a Potential Therapy for COVID-19 infected patients
Public title
Convalescent Plasma therapy for COVID-19 Patients
Purpose
Treatment
Inclusion/Exclusion criteria
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
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Molla Sadra Street
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2020-03-14, 1398/12/24
Ethics committee reference number
IR.BMSU.REC.1398.434
2
Ethics committee
Name of ethics committee
Ethical Committee of Higher Education and Research Institute of Blood Transfusion Medicine
Street address
Higher Education Institute of Blood Transfusion Medicine, Sheikh Fazlollah Nouri Highway, Shahid Hemmat Intersection , Next to Milad Tower
City
Tehran
Province
Tehran
Postal code
146651157
Approval date
2020-03-09, 1398/12/19
Ethics committee reference number
IR.TMI.REC.1398.031
Health conditions studied
1
Description of health condition studied
COVID-19 Disease
ICD-10 code
U07.02
ICD-10 code description
COVID-19 Disease
Primary outcomes
1
Description
Improving Respiratory function of patients
Timepoint
Every 24 hours
Method of measurement
Clinical and, Para-clinical
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
Control group: Patients hospitalized with COVID-19 disease who are receive routine treatment