COVID19NCT04383548
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
A study testing hyper immunoglobulins containing anti-Corona VS2 immunoglobulin in people with COVID19, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- COVID19
- What is being tested?
- hyper immunoglobulins containing anti-Corona VS2 immunoglobulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Passive immunization group (Group A)
- 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
- Patient group (group B):
- 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
Who cannot join
- Passive immunization group (Group A):
- Age less than 21 or above 50 years
- . Nasopharyngeal swab SARS-CoV-2 positive PCR
- . Presence of anti-SARS-CoV-2 IgM, IgG
- 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
- Patient group (group B):
Show all 9Show fewer
- Age less than 20 years
- . SARS-CoV-2 PCR negative
- . 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
Trial locations and contacts
No sites are listed yet.
About this study
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
Preparation of safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients to be used to:
- To determine efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19
- 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
Read the 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.
- Conditions
- COVID19
- Being tested
- hyper immunoglobulins containing anti-Corona VS2 immunoglobulin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyper immunoglobulins containing anti-Corona VS2 immunoglobulinOther
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 group | Role | What they receive |
|---|---|---|
| Hyper immunoglobulins have anti-Corona VS2 immunoglobulin | Experimental | safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients Receives: Other: hyper immunoglobulins containing anti-Corona VS2 immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaimaa Mokhtar Selim mohamed, Assiut University
- Investigators
- Maha A Mohamed, professor, Study director, Assiut univeristyMagdy El Ekiaby, Doctor, Principal investigator, Sabrawishy hospital,Dokki,Giza,EgyptAzza M Ez-Eldin, professor, Principal investigator, Assiut univeristyAlia M Hussein, professor, Principal investigator, Assiut univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383548
- Sponsor's protocol ID
- Mini-pooled IVIG in COVID19
- Status last verified
- May 2020
- First submitted
- 17 Apr 2020
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 15616839Chen 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.
PubMed 32113510El-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.
PubMed 19778318
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04383548
- Acronym / sponsor ID
- Mini-pooled IVIG in COVID19
- Conditions
- COVID19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preparation of safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients to be used to:
- To determine efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyper immunoglobulins have anti-Corona VS2 immunoglobulin | Experimental | Other: hyper immunoglobulins containing anti-Corona VS2 immunoglobulinsafe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Passive immunization group (Group A)
- 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
- Patient group (group B):
- 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
Key exclusion criteria (9 listed)
- Passive immunization group (Group A):
- Patient group (group B):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyper immunoglobulins containing anti-Corona VS2 immunoglobulinProspective randomized clinical study for efficacy of anti-SARS-CoV-2 hyper immunoglobulins prepared from COVID19 convalescent plasma using VIPS Mini-Pool IVIG medical device | Other | Hyper immunoglobulins have anti-Corona VS2 immunoglobulin |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Background: PubMed 15616839Cheng 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.
- Background: PubMed 32113510Chen 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.
- Background: PubMed 19778318El-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha A Mohamed, professor study director
Assiut univeristy
Magdy El Ekiaby, Doctor principal investigator
Sabrawishy hospital,Dokki,Giza,Egypt
Azza M Ez-Eldin, professor principal investigator
Assiut univeristy
Questions about this trial
What is this clinical trial studying?
A study testing hyper immunoglobulins containing anti-Corona VS2 immunoglobulin in people with COVID19, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alshaimaa M Selim, specialist (01003580480, shaimaamokhtargood@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of COVID19 hyper immunoglobulins for patients (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383548, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.