Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT04500067
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2020-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Immunoglobulin (IVIG, Bioven) Efficacy Assess for COVID-19 / SARS-CoV-2 Severe Pneumonia Complex Treatment
Sponsor:
Biopharma Plasma LLC
Organization:
Study Overview
Official Title:
An Open-label Multicenter Randomized Trial to Evaluate the Efficacy of Bioven, Manufactured by Biopharma Plasma, LLC, in Complex Therapy of Patients With Pneumonia Induced by COVID-19 / SARS-CoV-2
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pneumonia caused by coronavirus infection COVID-19 is characterized by a combination of several dangerous factors that consistently worsen the patient's condition: viral lung damage early in the disease; a sharp increase in inflammation on the background of an unbalanced immune response ("cytokine storm"); joining a bacterial infection.
The condition of patients deteriorates significantly mostly at cytokine storm development. The damaging of a large volume of lung tissue leads to develops of respiratory failure, respiratory distress syndrome, or shock. Ventilatory support becomes ineffective and patients die.
There are reports of the effectiveness of Human Normal Immunoglobulin for Intravenous Administration (IVIG) high doses when used as part of complex therapy in patients with pneumonia caused by coronavirus COVID-19. In particular, IVIG has a positive effect on survival rates, overall disease course, duration of stay in the intensive care unit, and ventilatory support duration.
The probable mechanism of action of high-dose IVIG therapy is considered to be a regulatory effect on the immune system. Similar is the known and confirmed effectiveness of IVIG for autoimmune diseases (Kavasaky disease, Guillain Barre syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy, Multifocal motor neuropathy).
This trial to assesses the Efficacy of IVIG (medication trade name - Bioven, manufactured by Biopharma Plasma LLC) in the High Immunomodulatory Dose in Complex Treatment of Severe Pneumonia Caused by COVID-19 / SARS-CoV-2
The condition of patients deteriorates significantly mostly at cytokine storm development. The damaging of a large volume of lung tissue leads to develops of respiratory failure, respiratory distress syndrome, or shock. Ventilatory support becomes ineffective and patients die.
There are reports of the effectiveness of Human Normal Immunoglobulin for Intravenous Administration (IVIG) high doses when used as part of complex therapy in patients with pneumonia caused by coronavirus COVID-19. In particular, IVIG has a positive effect on survival rates, overall disease course, duration of stay in the intensive care unit, and ventilatory support duration.
The probable mechanism of action of high-dose IVIG therapy is considered to be a regulatory effect on the immune system. Similar is the known and confirmed effectiveness of IVIG for autoimmune diseases (Kavasaky disease, Guillain Barre syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy, Multifocal motor neuropathy).
This trial to assesses the Efficacy of IVIG (medication trade name - Bioven, manufactured by Biopharma Plasma LLC) in the High Immunomodulatory Dose in Complex Treatment of Severe Pneumonia Caused by COVID-19 / SARS-CoV-2
Detailed Description:
The screening stage:
The patient or his legal representative must sign an informed consent. After signing the informed consent, the screening tests\&procedures are performed and the compliance with the inclusion / non-inclusion criteria is assessed.
For patients who have been screened and meet the inclusion criteria and do not fall under the exclusion criteria, a blinded randomization procedure is provided.
Randomization is performed by the IVRS method, according to the blinded-block patient's randomization table.
The clinical stage of the trial:
Begins after patient randomization. At the clinical stage, among other things, provides:
* Determination of the individual dose of the study drug (in the study group)
* Administration of the drug (in the study group)
* Registration of adverse events
* registration of information about taking antiviral drugs for the treatment of COVID-19;
* registration of information on symptomatic therapy and administration of drugs for the treatment of comorbidities;
* measurement of vital signs (blood pressure, heart rate, respiratory rate, body temperature);
* Determination of SPO2 level
* Determining the need for ventilation
* Determining the need for intensive care
* Assessment of compliance with the exclusion criteria
Patients in the Control Group will receive therapy recommended by the COVID-19 coronavirus infection treatment protocol, depending on the severity of their condition according to the prescribing list, which will not include immunoglobulin preparations.
Patients of the Study Group (IVIG) receive high-dose therapy with the study drug (Bioven, 10% solution for infusions produced by Biopharma Plasma LLC, Ukraine). The dose is calculated by body weight. Patients will also receive therapy recommended by the COVID-19 coronavirus infection treatment protocol, depending on the severity of their condition according to the prescribing list.
Bioven administered intravenously, at an initial rate of 0.5 - 1.0 ml/kg body weight/hour for 30 minutes. In the absence of any undesirable side effects, the rate of administration can be gradually increased (recommended increase by 0.5 - 1.5 ml/kg body weight/hour every 10 minutes). According to results previously accomplished clinical studies, the maximum rate of Bioven administration is up to 8.5 ml/kg body weight/hour.
Observation and completion stage:
Begins and continues from the last administration of the study drug until the discharge of the patient from the hospital, but not less than 28 days from the confirmation of the diagnosis of pneumonia caused by coronavirus infection COVID-19.
The following procedures are provided at the stage:
* registration of information about taking antiviral drugs for the treatment of COVID-19;
* registration of information on symptomatic therapy and administration of drugs for the treatment of comorbidities;
* measurement of vital signs (blood pressure, heart rate, respiratory rate, body temperature);
* determination of SPO2 level
* registration of the results of the examination of the lungs by computed tomography (or radiography)
* taking biomaterials for laboratory research:
* general blood test (erythrocytes, hemoglobin, expanded leukocyte formula, platelets, etc.);
* general analysis of urine;
* biochemical analysis of blood;
* state of the coagulation system
* determination of inflammatory factors in the dynamics (CRP, ferritin, procalcitonin; TNF-α), IL-1-beta, IL-6, complement component C3 (C3), circulating immune complexes (CIC), etc.),
* determination of IgG subclasses (G1, G2, G3, G4,);
* Determining the need for ventilation
* Determining the need for intensive care
* Adverse reactions registration
* Assessment of compliance with the exclusion criteria
The patient's condition is assessed daily till discharge; and by schedule after discharge (if it happen earlier), during 28 days period after diagnosis of severe pneumonia caused by coronavirus infection COVID-19 In case of death of the patient - the date and cause of death are fixed. The results of the study are evaluated by endpoints.
The patient or his legal representative must sign an informed consent. After signing the informed consent, the screening tests\&procedures are performed and the compliance with the inclusion / non-inclusion criteria is assessed.
For patients who have been screened and meet the inclusion criteria and do not fall under the exclusion criteria, a blinded randomization procedure is provided.
Randomization is performed by the IVRS method, according to the blinded-block patient's randomization table.
The clinical stage of the trial:
Begins after patient randomization. At the clinical stage, among other things, provides:
* Determination of the individual dose of the study drug (in the study group)
* Administration of the drug (in the study group)
* Registration of adverse events
* registration of information about taking antiviral drugs for the treatment of COVID-19;
* registration of information on symptomatic therapy and administration of drugs for the treatment of comorbidities;
* measurement of vital signs (blood pressure, heart rate, respiratory rate, body temperature);
* Determination of SPO2 level
* Determining the need for ventilation
* Determining the need for intensive care
* Assessment of compliance with the exclusion criteria
Patients in the Control Group will receive therapy recommended by the COVID-19 coronavirus infection treatment protocol, depending on the severity of their condition according to the prescribing list, which will not include immunoglobulin preparations.
Patients of the Study Group (IVIG) receive high-dose therapy with the study drug (Bioven, 10% solution for infusions produced by Biopharma Plasma LLC, Ukraine). The dose is calculated by body weight. Patients will also receive therapy recommended by the COVID-19 coronavirus infection treatment protocol, depending on the severity of their condition according to the prescribing list.
Bioven administered intravenously, at an initial rate of 0.5 - 1.0 ml/kg body weight/hour for 30 minutes. In the absence of any undesirable side effects, the rate of administration can be gradually increased (recommended increase by 0.5 - 1.5 ml/kg body weight/hour every 10 minutes). According to results previously accomplished clinical studies, the maximum rate of Bioven administration is up to 8.5 ml/kg body weight/hour.
Observation and completion stage:
Begins and continues from the last administration of the study drug until the discharge of the patient from the hospital, but not less than 28 days from the confirmation of the diagnosis of pneumonia caused by coronavirus infection COVID-19.
The following procedures are provided at the stage:
* registration of information about taking antiviral drugs for the treatment of COVID-19;
* registration of information on symptomatic therapy and administration of drugs for the treatment of comorbidities;
* measurement of vital signs (blood pressure, heart rate, respiratory rate, body temperature);
* determination of SPO2 level
* registration of the results of the examination of the lungs by computed tomography (or radiography)
* taking biomaterials for laboratory research:
* general blood test (erythrocytes, hemoglobin, expanded leukocyte formula, platelets, etc.);
* general analysis of urine;
* biochemical analysis of blood;
* state of the coagulation system
* determination of inflammatory factors in the dynamics (CRP, ferritin, procalcitonin; TNF-α), IL-1-beta, IL-6, complement component C3 (C3), circulating immune complexes (CIC), etc.),
* determination of IgG subclasses (G1, G2, G3, G4,);
* Determining the need for ventilation
* Determining the need for intensive care
* Adverse reactions registration
* Assessment of compliance with the exclusion criteria
The patient's condition is assessed daily till discharge; and by schedule after discharge (if it happen earlier), during 28 days period after diagnosis of severe pneumonia caused by coronavirus infection COVID-19 In case of death of the patient - the date and cause of death are fixed. The results of the study are evaluated by endpoints.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: