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
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 and/or treatment
of 6 - 10 individuals.
Other: hyper immunoglobulins containing anti-Corona VS2 immunoglobulin
Prospective randomized clinical study for efficacy of anti-SARS-CoV-2 hyper immunoglobulins prepared from COVID19 convalescent plasma using VIPS Mini-Pool IVIG medical device
Inclusion Criteria:
a. Passive immunization group (Group A)
1. 20 high risk exposed persons (HCPs) who are nasopharyngeal swab SARSCoV-2 PCR negative
and seronegative for SARS-CoV-2 IgM/IgG antibodies to receive prophylactic anti-
SARS-CoV-2 hyper immunoglobulin. Selected population can be both male and female with
age range 21 - 50 years b. 20 high risk persons (HCPs) who are nasopharyngeal swab
SARS-CoV-2 PCR negative and seronegative for SARS-CoV-2 IgM/IgG antibodies as control
group. Selected population can be both male and female with age range 21 - 50 years
2. Patient group (group B):
a. 30 patients with COVID19 disease and nasopharyngeal swab or sputum SARSCoV-2 positive
PCR to receive anti-SARS-CoV-2 in addition to applied clinical management protocol.
Selected test group can be male or female with age >20 years b. 30 patients with COVID-19
disease and nasopharyngeal swab or sputum SARS-CoV-2 PCR positive managed according to
applied clinical management protocols of COVID-19 disease as control group. Selected test
group can be male or female with age >30 years
Exclusion Criteria:
1. Passive immunization group (Group A):
1. Age less than 21 or above 50 years
2. . Nasopharyngeal swab SARS-CoV-2 positive PCR
3. . Presence of anti-SARS-CoV-2 IgM, IgG
4. Presence of comorbidities such as hypertension, diabetes, chronic renal disease,
previous thrombotic events or states of allergy such as urticaria or bronchial
asthma as well as previous adverse events due to infusion of IVIG
2. Patient group (group B):
1. Age less than 20 years
2. . SARS-CoV-2 PCR negative
3. . COVID-19 patients who may suffer from co morbidities such as hypertension,
diabetes, chronic renal disease, thrombotic tendency or history of adverse events
to IVIG as well as old age will be excluded to reduce the possibility of
development of serious adverse events related to infusion of IVIG unless it will
be for compassionate use in advanced stages of COVID-19 patients and after
obtaining informed consent
Alshaimaa M Selim, specialist
01003580480
shaimaamokhtargood@yahoo.com
Maha A Mohamed, professor
01000004572
atwa_maha@yahoo.com