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

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

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

Study Overview

• Status: Unknown
• Conditions: COVID19
• Intervention / Treatment: Other: hyper immunoglobulins containing anti-Corona VS2 immunoglobulin

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 and/or treatment of 6 - 10 individuals.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hyper immunoglobulins have anti-Corona VS2 immunoglobulin; safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of COVID19 hyper immunoglobulins for patients	efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19	2 weeks
Efficacy of COVID19 hyper immunoglobulins for high risk groups	efficacy of anti-SARS-CoV-2 hyper immunoglobulins in the prevention of infection in high risk groups exposed to SARS-CoV-2 infection	1 month
Safety of anti-SARS-CoV-2 hyper immunoglobulins assessed by percentage of adverse events	overall percentage of adverse events as hemolysis and anaphylaxis ,headache and other complains that occur during 72 hours of following infusion of anti-SARS-CoV-2 hyper immunoglobulins will be assessed by 1-vital sign 2-hemolysis by LDH and bilirubin level	72 hours

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Maha A Mohamed, professor, Assiut Univeristy; Principal Investigator: Magdy El Ekiaby, Doctor, Sabrawishy hospital,Dokki,Giza,Egypt; Principal Investigator: Azza M Ez-Eldin, professor, Assiut Univeristy; Principal Investigator: Alia M Hussein, professor, Assiut Univeristy

Publications and helpful links

General Publications

• Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
• Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.
• El-Ekiaby M, Sayed MA, Caron C, Burnouf S, El-Sharkawy N, Goubran H, Radosevich M, Goudemand J, Blum D, de Melo L, Soulie V, Adam J, Burnouf T. Solvent-detergent filtered (S/D-F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system. Transfus Med. 2010 Feb;20(1):48-61. doi: 10.1111/j.1365-3148.2009.00963.x. Epub 2009 Sep 23.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: May 10, 2020
• First Posted (ACTUAL): May 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 10, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: Mini-pooled IVIG in COVID19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No