Effect of Intravenous immunoglobulin (IVIG) versus Kaletra (lopinavir and ritonavir) tablets in patients with acute respiratory infection (COVID-19): A clinical trial studies
Investigation of the effect of Intravenous immunoglobulin (IVIG) in comparison with Kaletra (lopinavir and ritonavir) tablets in patients with acute respiratory COVID-19 infection
Design
This study is a non-randomized, not blinded clinical trial with control group in phase 2 and sample size of 20.
Settings and conduct
This interventional study will be conducted as a prospective, Single-center trial. 20 patients with COVID-19 infection admitted to Bohlool hospital and have not responded to routine treatment, will be selected. All patients who meet the eligibility criteria with informed consent will receive IVIG or Kaletra. Patient's symptoms and their severity, clinical examinations and findings of chest CT scan will be evaluated before and after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Subjects (men or women) at least 18 years with definitive diagnosis with COVID-1; Having one of the factors of decrease in consciousness level; hypoxemia; hypercapnia; Increased lung involvement despite treatment; Informed consent.Exclusion criteria: Sensitivity to IVIG; Pregnancy; Breastfeeding; IgA deficiency.
Intervention groups
Intervention group will receive a standard regimen for COVID-19 plus intravenous immunoglobulin (IVIG),They will receive 400 mg/kg/day of IVIg in 3 doses (max=25 g). Control group will receive Kaletra (200/50) two tablet every 12 hr for 7-14 days.
Main outcome variables
Improvement the radiologic and laboratory parameters; necessity to ICU admission; duration of ventilation; duration the hospitalization; the mortality rate; SpO2.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200418047116N1
Registration date:2020-05-04, 1399/02/15
Registration timing:registered_while_recruiting
Last update:2020-05-04, 1399/02/15
Update count:0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Negar Shafaei bajestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5723 6833
Email address
shafaei.n@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-10, 1398/12/20
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intravenous immunoglobulin (IVIG) versus Kaletra (lopinavir and ritonavir) tablets in patients with acute respiratory infection (COVID-19): A clinical trial studies
Public title
The effect of Intravenous immunoglobulin on COVID-19 infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive PCR for COVID -19
Informed consent for inclusion
Hypoxemia not responsive to oxygen therapy
Loss of consciousness (GCS<=14)
Hemodynamic instability
Hypercapnia
Extent of pulmonary involvement
Non-use estrogen-containing compounds
Non-be pregnant or breastfeeding
Exclusion criteria:
Sensitivity to IVIG
IgA deficiency history
Allergic reaction during IVIG injection
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Gonabad University of Medical Sciences
Street address
Dr.Mehdizade Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2020-04-06, 1399/01/18
Ethics committee reference number
IR.GMU.REC.1399.009
Health conditions studied
1
Description of health condition studied
COVID-19 disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Pulmonary manifestations
Timepoint
before and after treatment
Method of measurement
Computed Tomography scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intravenous immunoglobulin (IVIG), brand name Intratect ®, 400 mg/kg/day in 3 doses will be administered by slow intravenous infusion.
Category
Treatment - Drugs
2
Description
Control group: Lopinavir/ritonavir, brand name Kaletra®, two tablet of 200/50 mg dose every 12 hours will be administered orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bohlol Hospital
Full name of responsible person
Najme Davoodian
Street address
Vahdat Blvd.,Saadi St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Email
shafaei-n@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
Dr.Mehdizade Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Negar Shafaei Bajestani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Allameh Bohlool Gonabadi Hospital, Vahdat Blvd.,Saadi St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Fax
Email
Shafaei.n@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Negar Shafaei Bajestani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Allameh Bohlool Gonabadi Hospital, Vahdat Blvd.,Saadi St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Fax
Email
Shafaei.n@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Negar Shafaei Bajestani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Allameh Bohlool Gonabadi Hospital, Vahdat Blvd.,Saadi St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Fax
Email
Shafaei.n@gmu.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
The researchers in university and other scientific institutes.
Under which criteria data/document could be used
Help in managing of patients.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.