Evaluation of the effect of GCSF injection in treatment of COVID-19 patients with lymphopenia (less than 1000) in Kosar Hospital
Design
Clinical trial with control group, Randomized, Single-center, Sample size 10 people.
Settings and conduct
Kowsar Hospital in Semnan.
Granulocyte colony-stimulating factor (GCSF) stimulant dose is administered to patients as an intravenous dose. Then a blood test is done one day and 3 days after the injection to check the number of lymphocytes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Covid 19; Conscious consent of the patient. Exclusion criteria: Without lymphopenia.
Intervention groups
Intervention group: Granulocyte colony-stimulating factor (GCSF) stimulant dose is administered to patients as an intravenous dose. Then a blood test is done one day and 3 days after the injection to check the number of lymphocytes.
Control group: Patients are treated according to national protocol. Only for comparison with intervention group.
Main outcome variables
Blood lymphocytes.
General information
Reason for update
Acronym
Granulocyte - colony stimulating factor (G-CSF)
IRCT registration information
IRCT registration number:IRCT20200502047268N1
Registration date:2020-05-16, 1399/02/27
Registration timing:prospective
Last update:2020-05-16, 1399/02/27
Update count:0
Registration date
2020-05-16, 1399/02/27
Registrant information
Name
IRAN Akram alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1021
Email address
alizadeh.a@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of GCSF injection in treatment of COVID-19 patients with lymphopenia (less than 1000)
Public title
Evaluation of the effect of GCSF injection in treatment of COVID-19 patients with lymphopenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 pneumonia
Conscious consent of the patient
Exclusion criteria:
Without lymphopenia
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 2).
Using Excel software to generate random number tables
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-04-21, 1399/02/02
Ethics committee reference number
IR.SEMUMS.REC.1399. 13
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.01
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Blood lymphocytes
Timepoint
Befor entering the study and 3 days after drug injection
Method of measurement
Using hemocytometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Granulocyte colony-stimulating factor (GCSF) stimulant dose is administered to patients as an intravenous dose. Then a blood test is done one day and 3 days after the injection to check the number of lymphocytes.
Category
Treatment - Drugs
2
Description
Control group: Patients are treated according to national protocol. Only for comparison with intervention group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Amir sarabi
Street address
Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 0022
Email
alizadehbio@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaie
Street address
Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 0022
Email
alizadeh.a@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Amir Sarabi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Oncology
Street address
Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 0022
Email
drsam_amir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Akram Alizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 0022
Email
alizadeh.a@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Akram Alizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 0022
Email
alizadeh.a@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available