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

• ClinicalTrials.gov Identifier: NCT04383548
• Recruitment Status: Unknown
• First Posted: May 12, 2020
• Last Update Posted: May 12, 2020
• Sponsor: Assiut University
• Information provided by (Responsible Party): Alshaimaa Mokhtar Selim mohamed, Assiut University

Tracking Information

• First Submitted Date: April 17, 2020
• First Posted Date: May 12, 2020
• Last Update Posted Date: May 12, 2020
• Estimated Study Start Date: June 1, 2020
• Estimated Primary Completion Date: December 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 10, 2020)

• Efficacy of COVID19 hyper immunoglobulins for patients [ Time Frame: 2 weeks ]
  efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19
• Efficacy of COVID19 hyper immunoglobulins for high risk groups [ Time Frame: 1 month ]
  efficacy of anti-SARS-CoV-2 hyper immunoglobulins in the prevention of infection in high risk groups exposed to SARS-CoV-2 infection
• Safety of anti-SARS-CoV-2 hyper immunoglobulins assessed by percentage of adverse events [ Time Frame: 72 hours ]
  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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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

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

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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: COVID19

Intervention

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

Study Arms

Experimental: Hyper immunoglobulins have anti-Corona VS2 immunoglobulin

safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients

Intervention: Other: hyper immunoglobulins containing anti-Corona VS2 immunoglobulin

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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 10, 2020): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2021
• Estimated Primary Completion Date: December 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04383548
• Other Study ID Numbers: Mini-pooled IVIG in COVID19
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Alshaimaa Mokhtar Selim mohamed, Assiut University
• Original Responsible Party: Same as current
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: Assiut University
• Verification Date: May 2020