Ignite Creation Date:
2024-05-06 @ 2:40 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04383548
Status:
UNKNOWN
Last Update Posted:
2020-05-12
First Post:
2020-04-17
Brief Title:
Clinical Study for Efficacy of Anti-Corona VS2 Immunoglobulins Prepared From COVID19 Convalescent Plasma Prepared by VIPS Mini-Pool IVIG Medical Devices in Prevention of SARS-CoV-2 Infection in High Risk Groups as Well as Treatment of Early Cases of COVID19 Patients
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Randomized Prospective Clinical Study for Efficacy of Anti-Corona VS2 Immunoglobulins Prepared From COVID19 Convalescent Plasma in Prevention of Infection in High Risk Groups as Well as Treatment of Early Cases of COVID19 Patients
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
NOT_YET_RECRUITING
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:
Preparation of safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients to be used to
1 To determine efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19
2 To determine efficacy of anti-SARS-CoV-2 hyper immunoglobulins in the prevention of infection in high risk groups exposed to SARS-CoV-2 infection
1 To determine efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19
2 To determine efficacy of anti-SARS-CoV-2 hyper immunoglobulins in the prevention of infection in high risk groups exposed to SARS-CoV-2 infection
Detailed Description:
The current COVID19 pandemic poses a huge challenge on health authorities and infrastructure due to rapid progression of infection with an estimated rate of severe disease that needs hospitalization and medical intervention It is also noteworthy that health care workers are at high risk of contracting COVID19 when dealing with cases
Previous experience with Corona SARS demonstrated a therapeutic benefit of using convalescent plasma for patients with Corona SARS in Hong Kong Passive immunization using hyper immunoglobulin preparations against measles as well as early treatment was proven effective when compared to no intervention conservative approach A recent publication encourages the use of COVID19 convalescent serum for the preparation of hyper immunoglobulins to be used for passive immunization as well as treatment of early disease before the development of lower respiratory tract disease pneumonia
Provision of Convalescent COVID19 hyper immunoglobulin
This can be achieved through one of the following three approaches
Fist approach Convalescent COVID19 immunoglobulins can be obtained by transfusion of 1 - 4 units of COVID19 FFP for passive immunization or treatment of early disease The advantages of this approach is that it is easy to prepare such units of FFP through regular blood banks Disadvantages include variability of existence and levels of neutralizing COVID19 immunoglobulins in individual plasma units This may result in variability of effectiveness for such an approach for prevention and treatment Risk of transfusion transmitted infections as well as immunological adverse events due to infusion of large volume of FFP are among other disadvantages of using individual FFP units
Second approach Classical industrial COVID19 hyper immunoglobulins from convalescent donors This approach provides more consistent small volumes of concentrated hyperimmunoglobulin preparations due to pooling of plasma donations from large number of convalescent donors which bypasses the variability of neutralizing immunoglobulins in individual plasma donations The preparation of hyper immunoglobulins includes steps for virus inactivation which results in safer products compared to non-virally inactivated FFP Production of COVID19 convalescent hyper immunoglobulins under current situation is practically not feasible due to limited source COVID19 convalescent plasma regulatory hurdles and the large volume of production batches minimum of 100s of liters of convalescent plasma
Third approach Recently a Swiss company developed medical device to prepare Intravenous Immunoglobulin IVIG preparations from only 4 liters of plasma 20 units of FFP which is sufficient to produce 20 grams of IVIG The technology involves the concentration of immunoglobulins from 20 plasma donations into IVIG preparations as well as virus inactivation of lipid enveloped viruses HBV HCV HIV Corona VS2 Safety of Mini-Pool IVIG was proven in a previous clinical trial conducted in ITP pediatric population The yield of one batch of this Mini-Pool IVIG is about 20 gms which can be sufficient for prophylaxis andor treatment of 6 - 10 individuals
Previous experience with Corona SARS demonstrated a therapeutic benefit of using convalescent plasma for patients with Corona SARS in Hong Kong Passive immunization using hyper immunoglobulin preparations against measles as well as early treatment was proven effective when compared to no intervention conservative approach A recent publication encourages the use of COVID19 convalescent serum for the preparation of hyper immunoglobulins to be used for passive immunization as well as treatment of early disease before the development of lower respiratory tract disease pneumonia
Provision of Convalescent COVID19 hyper immunoglobulin
This can be achieved through one of the following three approaches
Fist approach Convalescent COVID19 immunoglobulins can be obtained by transfusion of 1 - 4 units of COVID19 FFP for passive immunization or treatment of early disease The advantages of this approach is that it is easy to prepare such units of FFP through regular blood banks Disadvantages include variability of existence and levels of neutralizing COVID19 immunoglobulins in individual plasma units This may result in variability of effectiveness for such an approach for prevention and treatment Risk of transfusion transmitted infections as well as immunological adverse events due to infusion of large volume of FFP are among other disadvantages of using individual FFP units
Second approach Classical industrial COVID19 hyper immunoglobulins from convalescent donors This approach provides more consistent small volumes of concentrated hyperimmunoglobulin preparations due to pooling of plasma donations from large number of convalescent donors which bypasses the variability of neutralizing immunoglobulins in individual plasma donations The preparation of hyper immunoglobulins includes steps for virus inactivation which results in safer products compared to non-virally inactivated FFP Production of COVID19 convalescent hyper immunoglobulins under current situation is practically not feasible due to limited source COVID19 convalescent plasma regulatory hurdles and the large volume of production batches minimum of 100s of liters of convalescent plasma
Third approach Recently a Swiss company developed medical device to prepare Intravenous Immunoglobulin IVIG preparations from only 4 liters of plasma 20 units of FFP which is sufficient to produce 20 grams of IVIG The technology involves the concentration of immunoglobulins from 20 plasma donations into IVIG preparations as well as virus inactivation of lipid enveloped viruses HBV HCV HIV Corona VS2 Safety of Mini-Pool IVIG was proven in a previous clinical trial conducted in ITP pediatric population The yield of one batch of this Mini-Pool IVIG is about 20 gms which can be sufficient for prophylaxis andor treatment of 6 - 10 individuals
Study Oversight
Has Oversight DMC:
None
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?:
None