Comparison between the efficacy of intravenous immunoglobulin and convalescent plasma in improving the condition of patients with COVID-19: A randomized clinical trial
Comparison between the efficacy of intravenous immunoglobulin and convalescent plasma in improving the condition of patients with COVID-19
Design
clinical trial with control group- randomized- parallel groups
Settings and conduct
This study is a clinical trial with control group that will be performed in Vali-e-Asr Hospital in Birjand. 15 COVID19 patients will be divided into three groups by permuted block randomization: intravenous immunoglobulin therapy group (5 patients), convalescent plasma therapy group (5 patients), and control group(5 patients).
Participants/Inclusion and exclusion criteria
This study is a clinical trial with control group that will be performed in Vali-e-Asr Hospital in Birjand. 15 COVID19 patients will be divided into three groups by permuted block randomization: intravenous immunoglobulin therapy group (5 patients), convalescent plasma therapy group (5 patients), and control group(5 patients). All groups will receive common national protocol treatments. While one group will receive intravenous immunoglobulin in addition to the common national protocol (400 mg/kg/d) and the other group will receive common national protocol treatments twice and 200 cc each time in addition to the common national protocol.
Intervention groups
common national protocol treatments+common national protocol treatments
common national protocol treatments+intravenous immunoglobulin
Main outcome variables
Lung involvement in X-ray and CT-scan, SPO2, LDH enzyme, viral load, acute phase protein, white blood cell count, ESR, length of hospital stay, duration of mechanical ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200413047056N1
Registration date:2020-04-17, 1399/01/29
Registration timing:prospective
Last update:2020-04-17, 1399/01/29
Update count:0
Registration date
2020-04-17, 1399/01/29
Registrant information
Name
malihe zangoue
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 7036
Email address
mzangoue@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the efficacy of intravenous immunoglobulin and convalescent plasma in improving the condition of patients with COVID-19: A randomized clinical trial
Public title
Comparison between the efficacy of intravenous immunoglobulin and convalescent plasma in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
RT-PCR Confirm the infection in the throat swab or sputum or lower respiratory tract samples.
Sign the Informed Consent Form on a voluntary basis.
Meet any of the following criteria for severe or critical ill conditions:Respiratory rate >=30/min; orRest SPO2<=90%; orPaO2/FiO2<=300mmHg; orRespiratory failure and needs mechanical ventilation; orMultiple organ failure and needs ICU monitoring
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization
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 Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari st.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2020-04-13, 1399/01/25
Ethics committee reference number
IR.BUMS.REC.1399.008
Health conditions studied
1
Description of health condition studied
COVID-19 disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Lung involvement in X-ray and CT-scan, SPO2, LDH enzyme, viral load, acute phase protein, white blood cell count, ESR, length of hospital stay, duration of mechanical ventilation
Timepoint
from the start of the intervention for 12 days
Method of measurement
Blood and biochemical factors are measured using laboratory tests by an autoanalyzer. Pulmonary function indicators are measured by pulse oximetry and ABG.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the common national protocol, this group will receive convalescent plasma of recovered individuals twice and 200 cc each time.
Category
Treatment - Other
2
Description
Intervention group: In addition to the common national protocol, this group will receive intravenous immunoglobulin (400mg/kg/d).
Category
Treatment - Other
3
Description
Control group: This group will receive common national protocol.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali- e- Asr hospital
Full name of responsible person
Malihe Zangoue
Street address
Vali- e- Asr hospital , Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3234 7036
Email
mzangoue@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba Kazemi
Street address
Birjand University of Medical Sciences, Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Malihe Zangoue
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Birjand university of medical sciences, Ghaffari st.,
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
mzangoue@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Fereidouni
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Birjand University of Medical Sciences, Ghaffari st.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
dr.m.fereidouni@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Malihe Zangoue
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 41 , 24th alley, Ghaffari st.
City
Birjand
Province
South Khorasan
Postal code
9717945341
Phone
+98 56 3234 7036
Fax
Email
mzangoue@yahoo.com
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
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